Comparison of Depression Interventions after Acute Coronary Syndrome. Treatment Manual

Transcription

1 Comparison of Depression Interventions after Acute Coronary Syndrome Treatment Manual v. 05/11/2010

2 Table of Contents Treatment Manual... 0 Table of Contents CODIACS TREATMENT MANUAL BACKGROUND AND OVERVIEW... 4 Post-ACS Depressive Symptoms... 4 Overview of the Enhanced Depression Care Approach... 4 Overview of Enhanced Depression Care The Team... 5 The Patient... 6 The Central PST Treatment Specialist (PST-TS)... 6 Case Supervision... 6 The Site Team Antidepressant Medication Treatment Specialist (M-TS)... 6 Clinical consultation... 6 Stepped care decisions and direct patient consultation on treatment resistant cases INTERVENTION FLOW... 7 Initial Patient Contact after Randomization... 7 Scheduling the Initial Visit with the PST-TS or M-TS... 7 PST... 7 Medication... 7 Initial Visit with the PST-TS or M-TS - Usually within 1 Week of Randomization... 7 PST... 7 Anti-Depressant Medication... 8 Initial Treatment Course (6-8 Weeks)... 8 Assessment of Treatment Course- (Week 6-8 and 14-16)... 9 Continuation and Maintenance Phase STEPPED CARE FOR POST-ACS DEPRESSIVE SYMPTOMS Stepped Care Treatment Algorithm Stepped Care Details Initial treatment choice (Step 1) Titration of initial medication dose Determination of treatment response Antidepressant selection at Step Augmentation Strategies Step Additional treatments to be considered during the program Some Special Populations Patients with comorbid anxiety and panic disorders: Patients with comorbid alcohol or substance abuse Patients with psychotic depression Patient with bipolar depression: MANAGEMENT OF DEPRESSIVE SYMPTOMS IN PRIMARY CARE/OUTPATIENT CARE A. Seven Key Challenges in Managing Depression B. Diagnosing Depressive symptoms in Primary Care/Outpatient C. Conditions Characterized by Depressive Symptoms D. Patient Information about Antidepressant Medications How do antidepressants work? How to find an antidepressant that works for you What about side effects? E. Common Questions about Treatments for Depression Questions about antidepressant medications Questions about Problem Solving Treatment (PST): F. Guidelines for Using Antidepressant Medications

3 1. Antidepressant Medication Dosing Titrating Commonly Used Antidepressants Guidelines for Switching Antidepressants Rates of SSRI Antidepressant Side Effects across Clinical Trials a Strategies for Managing Antidepressant Side Effects Antidepressant Drug Interactions Troubleshooting: What to Do if Patients Don t Improve as Expected DOCUMENTING AND TRACKING CLINICAL ENCOUNTERS APPENDICES APPENDIX A: GUIDELINES TO TALKING TO PATIENTS AND CAREGIVERS ABOUT DEPRESSIVE SYMPTOMS Working with older adults experiencing depressive symptoms: Working with difficult patients: Working with older adults: Working with minority elderly: Working with family members and significant others: APPENDIX B: PSYCHIATRIC EVALUATION FOR PERSISTENT DEPRESSION APPENDIX C: RESOURCES FOR THE TREATMENT SPECIALIST (TS) SCRIPT FOR INITIAL TELEPHONE CALL GUIDE FOR THE INITIAL VISIT GUIDE TO MAKING A Relapse Prevention PLAN PLAN FOR PSYCHIATRIC EMERGENCIES Training Role Plays for Initial Assessment and Follow-up PHQ Clinical Evaluation of Current Depression (optional) TREATING INSOMNIA APPENDIX D. How to Schedule a PST Session How to Request Access How to Schedule an Initial PST Session How to Schedule Subsequent PST Sessions Questions APPENDIX E: Tracking Forms Psychiatric Evaluation PST Initial Assessment PST Follow Up Contact PHQ-9 History and Missed Appointments Log SESSIONS MISSED SESSIONS Date PHQ9 Score Location (1) Office (2) Phone (3) Webcam Contact Duration (minutes) Suicidality Form Completed (No / Yes) Unanticipated Problem Reported (No / Yes) Date Reason (1) No show (2) Cancelled/not rescheduled (3) Rescheduled

4 MEDICATION CHANGES Date Medication Dose Units Treatment Change Review RELAPSE PREVENTION PLAN APPENDIX F: NATIONAL AND LOCAL RESOURCES NATIONAL RESOURCES OTHER AGING-RELATED WEBSITES LOCAL RESOURCES APPENDIX G. Schedule and Timing of Measures

5 1. CODIACS TREATMENT MANUAL BACKGROUND AND OVERVIEW Post-ACS Depressive Symptoms Depressive symptoms are common and often persistent in patients after an Acute Coronary Syndrome. Up to 35% of patients experience some degree of depressive symptoms or dysphoria after an acute coronary syndrome (ACS). For many, these symptoms can persist for months. In some, these symptoms give rise to diagnosable depressive disorders. The importance of this phenomenon is underlined by the many studies that have found this clinical presentation to predict early death or reinfarction after an initial cardiac event. Post-ACS depressive symptoms have a profound impact on functioning, quality of life, and health care costs. Post-ACS depressive symptoms have been associated with impairments in physical, mental, and social functioning and health related quality of life. Although many cardiac patients adapt to their medical illness successfully, the development of depressive symptoms can inhibit this adaptation and lead to an amplification of physical symptoms. Depressive symptoms can also increase health care costs. Few post-acs patients receive specialty services for depressive symptoms. As the care of the cardiac patient has been revolutionized over the past decade, the focus of the treating physician has become more and more focused on the details of the cardiac disease process. Often lost in this approach is the way the patient is adjusting to their medical condition the thoughts and feelings they are having, their ability to grapple with the necessary changes in lifestyle, and the loss of roles they often experience. These factors can give rise to adjustment problems that can eventually lead to elevated depressive symptoms and depressive disorders. There are significant gaps between what is known about the efficacy of treatments for depression under research conditions and the effectiveness of care for elevated depressive symptoms in post-acs patients. Depression treatments are well tolerated and accepted in psychiatric patients. Further, their efficacy and effectiveness have been repeatedly supported by large randomized controlled trials (RCTs), again predominantly in psychiatric patients. However, observational studies of post-acs patients have demonstrated that the typical course of depression may be shorter, but that even subthreshold symptoms of depression predict adverse clinical outcomes such as re-hospitalizations for cardiac events and mortality. The willingness to volunteer and accept intervention may be lower in patients with sub-threshold symptoms of depression who do not fulfill diagnostic criteria for major depressive episode and who have not themselves presented seeking treatment. This should be considered when extending existing depression treatments to a post-acs population. Overview of the Enhanced Depression Care Approach A patient with persistent depressive symptoms 2-4 months post-acs, as evidenced by a score on the Beck Depression Inventory (BDI) > 15 on one occasion, or 10 and < 15 on each of 2 occasions, is enrolled in the study and randomized to either Referred Care or Stepped Care. Stepped Care includes, a) patient preference for either brief, problem solving therapy (PST), delivered centrally or antidepressant medication managed at the local site, and 2) review of progress at approximately 2-month intervals, with stepping up of care if sufficient progress is not being realized. Stepped care is delivered by a team of professionals in collaboration with the patient. The Treatment Team includes the site Unblinded Coordinator (UC), the central PST Specialist, and the site Medication Prescriber (psychiatrist, physician, or APRN). 4

6 The UC assigned to work with patients who are randomized to Stepped Care conducts an initial assessment, provides patient education regarding the Stepped Care treatment approach, and helps the patient make their choice as to their treatment preference either Problem Solving Therapy (PST) or antidepressant medication. The patient is thus encouraged to become an active participant in their treatment. The UC coordinates all depression care delivered as part of the patient s participation in the study, keeping the patient s regular health care provider informed. The UC also participates in the regular CODIACS Treatment meetings along with other members of the treatment team. The treatment team also conducts a formal review of the patient s progress at key time points over the 6-month treatment window. These key points are 6-8 weeks and weeks after treatment begins. For patients who demonstrate an insufficient response to treatment at these designated time points, the team will recommend augmentation of initial treatment or switching to another treatment. Overview of Enhanced Depression Care Step 1 Patient Choice 6-8 weeks 6-8 weeks Step 2 Antidepressant (usually Sertraline)* Insufficient response options: Augment with PST Switch to different antidepressant type Full response: Maintenance PST Insufficient response options: Augment with 1 st line antidepressant Switch to 1 st line antidepressant Full response: Maintenance Insufficient response options: Insufficient response options: Step 3 Augment with PST Augment with other antidepressant Referral for other types of psychotherapy Augment with other antidepressant Referral for other types of psychotherapy Full response: Maintenance Full response: Maintenance * If history of SSRI intolerance/unresponsiveness, another antidepressant class is considered 2. The Team Stepped care is delivered to a study patient by an organized team of professionals including the Unblinded Coordinator (UC), the Central PST-Treatment Specialist (PST-TS), a local team Medication Treatment Specialist (M-TS) - e.g., physician or APRN - responsible for prescribing and managing antidepressant medication, and other local support personnel as needed. This clinical team meets regularly (e.g., weekly) to discuss new and ongoing patients. The patient s treating cardiologist or other primary physician is kept informed about the patient s participation in the trial, and the depression treatment he or she is receiving, using standard study forms developed for this use.. 5

7 The Patient The program aims to include the patient as an active collaborator in his or her treatment. Patients are given a copy of an educational brochure on post-acs depressive symptoms and the approach taken in the CODIACS study. This brochure is used by the UC to explain the study to patient, and the choices they have in the type of treatment they receive. The randomization visit with the UC has a heavy emphasis on patient education and patient activation. The UC and the patient review the educational brochure and address any questions about depression treatments. The UC also encourages the patient to discuss the educational brochure with his or her spouse, partner, friends, other significant others, or caregivers. The Central PST Treatment Specialist (PST-TS) For patients who choose PST, treatment is provided centrally by a Central Problem Solving Therapy Treatment Specialist (PST-TS). This individual works with local team members throughout a patient s participation in the study, and closely follows each patient until he or she has reached a requisite level of improvement (see section on Continuation and Maintenance). After a PST patient is in remission, the PST-TS completes a relapse prevention plan and follows the patient with monthly telephone contacts and additional contacts as needed to reduce their risk of relapse or depression recurrence. The PST-TS also documents all services provided to patients using forms developed for this purpose, with copies provided securely to the local site and the DCC. Case Supervision The PST-TS receives protocol clinical supervision within the context of the Treatment QA Core, and consultation during weekly team meetings. During these meetings, the PST-TS goes over their caseload and discusses both new patients and ongoing patients who are experiencing difficulties with their treatments or are not responding as expected. This weekly meeting also facilitates effective and efficient communication and interaction between all members of the treatment team. The site team members (e.g., UC, antidepressant medication providers) are also available to the PST-TS throughout the week to answer clinical or logistic questions. The Site Team Antidepressant Medication Treatment Specialist (M-TS) Some study patients randomized to receive Stepped Care will elect antidepressant medication as their initial treatment choice, while some others may be placed on these medications as part of being stepped up at formal treatment reviews due to insufficient treatment progress with PST. Antidepressant medication is prescribed locally, according to CODIACS study algorithms. The individual(s) providing these medications have two essential responsibilities. Clinical consultation These team members meet weekly with the UC, PST-TS, and other clinical team members to review treatment plans for all new cases and discuss all cases that are not improving as expected. They are available to the PST-TS by beeper or telephone to discuss any psychiatric questions or emergencies. The M-TS(s) also specifically consults on questions concerning pharmacological treatment of patients participating in the CODIACS study. Stepped care decisions and direct patient consultation on treatment resistant cases. The Treatment Team - including the central PST-TS, conduct a formal review of a patient s progress after 6-8 weeks and weeks (see Appendix E, Treatment Change Form). For patients who do not have a sufficient response to treatment at these designated time points, the Team will recommend augmentation of initial treatment or switching to another treatment. If it is determined that a patient s depressive symptoms would be better cared for in a specialty mental health setting outside of the study, the local team (UC, M-TS, and/or others) can make a referral to appropriate specialty mental health care in consultation with other members of the local team (e.g., study psychologist or psychiatrist). Extended consultations with the patient may be involved as a precursor to making these recommendations. These consultations are focused on a 6

8 more comprehensive diagnostic evaluation and assessment, more detailed treatment recommendations, and possibly recommendations for more complex management outside of the study, in collaboration with the patient s health care providers. Team members (e.g., psychiatrists/psychologists) who see patients for in person consultations may use the web based systems to engage in and document these clinical encounters. 3. INTERVENTION FLOW Initial Patient Contact after Randomization Members of the screening and recruitment team identify the patient as eligible for randomization and patients who consent are randomized to either intervention (Stepped Care) or usual cardiologic care (Referred Care). The UC either immediately sees patients randomized to Stepped Care or contacts them by telephone to arrange an initial visit. The goals of this contact are: - Determine the patient s treatment preference (PST or Medication); - Arrange for a scheduled appointment with the appropriate Treatment Specialist; and - Answer any questions or concerns the patient may have at this point. Appendix C1 suggests a script for this initial telephone call. Scheduling the Initial Visit with the PST-TS or M-TS The local site UC will be responsible for arranging the initial visit, distributing the appropriate information to the PTS or MTS as indicated, and following up with this individual to ensure that the initial visit has been scheduled and completed. It is suggested that the UC supply this individual with the appropriate Evaluation Forms (see Appendix E) prior to the initial visit and subsequent visits. PST If the patient chooses PST, the UC will arrange the first PST session with the central Treatment Specialist during that contact. This will include scheduling the visit on Google calendars, making all arrangements for the video-conference link with the central PST-TS and for making all necessary introductions to that therapist at that time. See Appendix D: How to Schedule a PST Sessions. Medication If the patient chooses anti-depressant medication, the local UC will arrange the first Medication session at that time. When possible, the UC will contact the M-TS with the patient and find a time for the initial medication visit. If this is not possible, then the UC will inform the patient that the M-TS will be directly in touch with him/her to schedule the initial visit. The UC will then forward the patient s contact information to the M-TS according to local site protocol (e.g. or phone call). The M-TS will contact the patient to arrange the initial visit. Initial Visit with the PST-TS or M-TS - Usually within 1 Week of Randomization The initial visit with the PST-TS or M-TS should occur within one-week of randomization. This visit focuses on initial clinical assessment, patient education, and discussion of initial treatment plans, and follows the general outline provided in Appendix C2. At the end of the visit, the PST-TS/M-TS completes an Evaluation form (PST-TS complete PST Initial Form and M-TS completes Psych Form; see Appendix E). The UC informs the cardiologic care provider about the patient s initial treatment in the study, using the standard letter devised for this purpose. PST The first session will occur at the outpatient practice/recruiting spot, in a private office, with a computer and a webcam. The UC will join in the first session for the first 10 minutes or so, while general questions are asked (before the formal psychiatric history/treatment questioning) to ensure the equipment is working, and that introductions occur between patient and the PST-TS. The UC 7

9 then leaves the room. History of depression and prior treatment is taken by the PST-TS, and PST is initiated. The patient then has the choice of scheduling future sessions in the office, with the webcam, or by phone, or a combination of these. A local psychologist, psychiatrist, or responsible physician is available for emergencies and available for contact by the PST-TS if an emergency occurs. The centralized PST-TS will participate by phone in the regular site clinical team meetings for all PST and anti-depressant patients, where progress/barriers are reviewed and discussed. Anti-Depressant Medication If the patient chooses antidepressant medication, the local M-TS will provide a prescription after a visit with the patient, following the pharmacotherapy protocol for selection of the agent and dose, and such treatment will begin immediately. The local M-TS may be a study psychiatrist/physician/advanced nurse practitioner. Patients who are already on antidepressant medication but demonstrate trial eligibility at the time of the initial visit will be discussed within the clinical team, and recommendations will be made for initiating protocol treatment, in collaboration/consultation with the treatment provider who prescribed the antidepressant medication. Initial Treatment Course (6-8 Weeks) After initiating treatment, the PST-TS/M-TS will have a phone contact before the next visit. This contact will be to see how the patient is following through with their homework (if they are doing PST) and/or to make sure that the patient is taking their medication and not experiencing any side effects that might lead to early treatment dropout. A guideline on how to manage antidepressants is provided below. The PST-TS will then have weekly contact with the patient during the active treatment phase. These contacts can be via webcam or by telephone, based on participant preference. For the M- TS, at a minimum, the first two visits should be conducted in person as medication dose is titrated up. During each follow-up contact, the PST-TS/M-TS will assess the patient s symptoms by asking the patient to complete the 9-item Patient Health Questionnaire (see Appendix C6). The PHQ-9 can be completed by the patient at the start of each visit in 2-3 minutes and scored quickly by the PST- TS/M-TS. It often provides a good opportunity at the beginning of a session to start a discussion of changes in the patient s symptoms. The PHQ-9 also can provide the team with a rough indicator as to the patient s progress. Copies of completed PHQ-9 forms will be securely sent to the local site and the DCC. The PST-TS/M-TS will document all follow-up contacts using an Evaluation Form (see Appendix E). Patients who are started in PST as the first line of treatment will be seen for 4-16 sessions by the PST-TS (see separate PST treatment manual), according to treatment progress and achievement of criterion PHQ-9 score. These sessions will usually be scheduled weekly but not less frequently than every other week. Because the overall strategy may include elements other than PST, each follow-up visit should be started with a minute period in which the PST-TS reassesses the patient s symptoms using the PHQ-9 and reviews any questions. After these initial minutes, the PST-TS tells the patient that he / she is now formally starting with a 30 minute PST session. This will allow the patient and the PST-TS to focus on PST as outlined in the separate PST treatment manual while attending to other clinical tasks as needed at the beginning of a visit. The PST-TS will consult with the team psychologist/ psychiatrist as needed if the patient is experiencing symptoms or problems that are not easily addressed. The patient may require visits 8

10 with the psychologist/psychiatrist if such problems are not easily resolved by the PST-TS so as to determine whether out of study treatment is indicated. The PST-TS will immediately contact and consult with the team psychologist/psychiatrist if the patient develops any of the following problems: - acute suicidal symptoms - psychotic symptoms - manic symptoms - severe lack of appetite and insufficient PO intake or rapid weight loss - suspected alcohol or drug misuse (including prescription medications) - severe side effects - skin rash (small, red, itching, and spreading) - seizures or severe tremors - vomiting - fever - edema (face or body) - ataxia - confusion Each clinical team will use a local plan for the evaluation and treatment of psychiatric emergencies such as acute suicidality (see Appendix C5). This plan starts with an evaluation by the PST-TS/M- TS and is integrated with the response mechanisms for psychiatric emergencies that are available at each site s system of care. This is especially important to assure coverage during times when the PST-TS is not immediately available and to ensure that treatment plans for psychiatric emergencies involve the larger treatment setting as needed. As part of their orientation to the study, patients will be informed of the steps to follow should any emergency arise. The local UC plays an essential role in this regard. Assessment of Treatment Course- (Week 6-8 and 14-16) All patients will have a more formal assessment visit at 6-8 weeks after initiating treatment and again at weeks. The purpose of these assessments is to formally assess response to the treatment and to determine whether the patient s symptoms are on the appropriate response trajectory. Patients who have not had a sufficient response to the first line of treatment will be discussed in the regular clinical team meeting; they may also be seen for a consultation by the team psychologist/psychiatrist. After discussion, the team will decide with the patient on a 2 nd course of action following the guidelines provided by the stepped care model below. Patients who demonstrate a sufficient treatment response will, with their assent, remain on the care they have been receiving. Patients who have had a successful response to treatment will complete a Relapse Prevention Plan and will be encouraged to engage in appropriate maintenance activities (e.g., continue pleasurable activities, stay on maintenance medication). They will also be followed on a monthly basis by the PST-TS/M-TS and encouraged to contact that person or the UC if symptoms of depression return or if they have questions about their treatment. Continuation and Maintenance Phase Patients who have had a successful treatment response, defined as a PHQ-9 score of < 3 for two consecutive treatment sessions, will meet with the PST-TS/M-TS to complete a Relapse Prevention Plan (see Appendix E) and will be encouraged to engage in appropriate maintenance activities (e.g., continue pleasurable activities, stay on maintenance medication). They will also be followed on a monthly basis by the PST-TS/M-TS and encouraged to contact that person or the UC if symptoms of depression return or if they have questions about their treatment.. They will be 9

11 followed with monthly telephone calls for the remainder of their study participation. During each of these telephone calls, the PHQ-9 will be administered (see Appendix C6). The PHQ-9 scores will be used to determine whether the patient should continue with maintenance or return to active study treatment. Specifically, If during a Maintenance monthly telephone call, the patient has a PHQ-9 score of > 4, the PTS-TS/M-TS will call one week later to administer the PHQ-9. If the second PHQ-9 score is > 4, then the PST-TS/M-TS will encourage the patient to resume study treatment. All patients are encouraged to stay on continuation treatment (either maintenance PST or full dose of the antidepressant that led to clinical response) for at least 6 months after their symptoms are in remission. Patients who are at high risk for relapse (history of dysthymia, more than 2 prior depressive episodes, or persistent depressive symptoms) are encouraged to continue maintenance treatments for at least 2 years. Since study treatment ends after 6 months of enrollment, the local team will work with the patient s provider to ensure that proper follow-up is arranged at the conclusion of study treatment. During study treatment, patients will be encouraged to call their PST-TS/M-TS if symptoms of depression return or if they have questions about their treatment. Patients who show signs of recurrence or relapse during this follow-up period will be discussed in the clinical team meeting and may be scheduled for additional follow-up visits with their PST-TS/M-TS as clinically indicated. 4. STEPPED CARE FOR POST-ACS DEPRESSIVE SYMPTOMS CODIACS patients are likely to differ in terms of any prior history of adjustment problems, depressive disorders, treatment histories, current treatments, and medical and other comorbidities. Some patients will already be on active treatments, most commonly antidepressants. Others may be receiving treatments of questionable or limited benefit such as benzodiazepines or other class(es) of medications. Others may have had counseling for adjustment problems and/or depression but still have elevated depressive symptoms. Some patients may have a long history of problems with depression while others may be experiencing a first episode of elevated depressive symptoms. Some patients will have significant comorbid medical or psychiatric disorders such as panic disorder or PTSD. Some patients have strong preferences for antidepressant medications or psychotherapy, and such treatment preferences will be incorporated in treatment planning. Because of this considerable variation in each patient s clinical circumstances, it is not possible to specify a treatment algorithm that will be a perfect fit for each patient. The stepped care treatment algorithm outlined in the next few pages provides a general guideline to be followed in treating CODIACS patients with depressive symptoms. Within this guideline, the clinical team will have to use their best clinical judgments to ensure that patients enter the stepped care algorithm at the correct step and that each patient has a treatment plan that is best suited for his or her circumstances. The recommended stepped care algorithm is based on a number of consensus statements and treatment guidelines for depression in primary care: - AHCPR Treatment Guidelines for Depression in Primary Care (AHCPR 1993) - Treatment recommendations by a consensus panel convened by the American Association for Geriatric Psychiatrists (Am J Geriatr Psychiatry 1996) and a recent Consensus Statement on Late-Life Depression by the DBSA (Depressive and Bipolar Support Alliance; 2002) - Treatment Guidelines for Major Depression by the American Psychiatric Association including those arising from STAR*D 10

12 The recommendations from these consensus statements and guidelines were adapted for the treatment of post-acs patients with persistent high BDI, 2-4 months after their index ACS event by the COPES study investigators. The ultimate goals of treatment are to (a) achieve symptomatic remission (see below) and to (b) prevent relapse and recurrence of symptoms. Step 1 Stepped Care Treatment Algorithm Patient Choice 6-8 weeks 6-8 weeks Step 2 Antidepressant (usually Sertraline)* Insufficient response options: Augment with PST Switch to different antidepressant type Full response: Maintenance PST Insufficient response options: Augment with 1 st line antidepressant Switch to 1 st line antidepressant Full response: Maintenance Insufficient response options: Insufficient response options: Step 3 Augment with PST Augment with other antidepressant Referral for other types of psychotherapy Augment with other antidepressant Referral for other types of psychotherapy Full response: Maintenance Full response: Maintenance * If history of SSRI intolerance/unresponsiveness, another antidepressant class is considered * Patients who come into the trial with a history of intolerance or unresponsiveness to SSRI medication will be started with a Step 2 medication (bupropion). 11

13 Stepped Care Details Initial treatment choice (Step 1) Patients who have a preference for psychotherapy will be started on problem solving treatment (PST) in Step 1. See Appendix C2 for details on this initial choice. For patients who have a preference for medication, the Medical Treatment Specialist (M-TS) will gather a medical history specifically concerning any prior treatment for depression, with a focus on antidepressant medication. If the patient reports no prior history, begin with sertraline. If the patient reports that they responded to sertaline, citalopram, or bupoprion in past, treatment should begin with that medication. If the patient reports that they experienced side effects with sertraline or citalopram, begin with the other medication. If the patient reports a history of intolerance or unresponsiveness to SSRI medication they will be started on bupropion. Titration of initial medication dose Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week, with further adjustment higher in the therapeutic range possible at 3-4 weeks (see Section F2 for dosing guidelines). Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated. If a patient cannot tolerate a particular treatment (i.e., intolerable side effects even with careful titration and clinical management), a switch to an alternative antidepressant or PST after 2-4 weeks and restart step 1. Strategies for managing common side effects of antidepressants are outlined in Section F5. An adequate response to antidepressant treatment in Step 1 is defined as a 20% or greater reduction in PHQ-9 score from baseline. If this is not attained by 1-2 weeks subsequent to achieving a therapeutic medication dose (e.g., mg sertraline, 40mg citalopram), the medication should be switched (e.g., from sertraline to citalopram or vice versa). Determination of treatment response An adequate treatment response is defined by a sufficient response trajectory, as follows: Decision rules: Initial PHQ Score Needed Improvement to Remain at Step % (score of 4-7) % (score of 6-10) > 20 60% (score of 8-11) Patients who are on the above response trajectory stay in Step 1. The decision at 6-8 weeks is based on the score at the initial visit, and the decision at weeks is based on the score at 8 weeks. Patients who have a remission of symptoms (PHQ < 3 for 2 weeks) proceed to relapse prevention planning (see below) and maintenance treatment. Patients who do not have a sufficient response to Step 1 treatment will be discussed in the weekly clinical team meeting in consultation with the treatment providers, and the decision made, with consideration of the patient s preferences, for a change in treatment regimen. Appendix B provides an outline for such consultations. Antidepressant selection at Step 2 Patients who have failed an adequate trial of a first-line antidepressant and wish to continue with pharmacotherapy as at least a part of their overall treatment, will be considered for a trial of an antidepressant from a different class. The choice of the second agent may vary depending on the clinical circumstances. If the first trial was with an SSRI (sertraline, citalopram), bupropion is considered. 12

14 Augmentation Strategies Recommended augmentation strategies at this stage are to augment an antidepressant with PST, or augment PST with a first line antidepressant (sertraline, citalapram). Step 3 Patients who have not had a sufficient response at Step 2 will be discussed in the weekly clinical team meeting. Potential treatment strategies for step 3 include: - Combination of antidepressant and PST (if this has not already been tried at Step 2) - Other types of psychotherapy such as CBT. - Other augmentation strategies (SSRI + bupropion). - Out of study treatment for comorbid psychiatric disorders such as OCD, panic disorder, or PTSD. When patients are referred for out of study mental health care, they can continue to work with the treatment team. The appropriate TS follows them with regular (at least monthly) telephone calls and keeps the patient s regular cardiology care provider apprised of the patient s progress. Additional treatments to be considered during the program. Additional treatments that may be considered by the appropriate TS or the clinical team at any stage in the treatment course can include as examples: - referrals to self help groups such as AA and NA, - referrals to support groups run by the Depression and Bipolar Support Alliance (DBSA), Alzheimer s Association, ALANON, or caregiver support groups, - referrals to other community resources, - referrals to specialty services such as a chronic pain clinic Each local treatment Team will develop and maintain a local resource list for such referrals (see Appendix E). Some Special Populations Patients with comorbid anxiety and panic disorders: In general, patients with comorbid anxiety disorders such as panic disorder can be treated using antidepressants such as SSRIs. Such patients should usually be started on low doses of an SSRI and slowly titrated up to a therapeutic dose as tolerated because the medication can cause a transient worsening of anxiety symptoms. In some cases, the use of a benzodiazepine such as clonazepam or lorazepam is helpful to reduce severe anxiety during the initial weeks of treatment, but the long term use of such agents is to be avoided because they can result in physical dependence, cognitive and motor impairment, falls, and other accidents. Consultation with the team psychiatrist will occur in making treatment plans for patients with comorbid depressive symptoms and anxiety disorders. Patients with comorbid alcohol or substance abuse. This is a study exclusion and patients with these conditions will not be invited to participate in the study. Patients with psychotic depression. This is a study exclusion and patients with these conditions will not be invited to participate in the study. Patient with bipolar depression: This is a study exclusion and patients with these conditions will not be invited to participate in the study. 13

15 5. MANAGEMENT OF DEPRESSIVE SYMPTOMS IN PRIMARY CARE/OUTPATIENT CARE A. Seven Key Challenges in Managing Depression 1. Make a diagnosis. 2. Educate and recruit the patient as a partner in treatment. 3. Start with the best possible treatment. Avoid minor tranquilizers. Use antidepressants or psychotherapy. 4. Use an adequate dose. 5. Treat long enough. (Patients often take 6 to 10 weeks to respond.) 6. Follow outcomes and adjust treatment as needed. Consider consultation if patient is not improving. 7. Prevent relapse. (50% risk after one episode, 70% after two episodes and 90% after three episodes.) B. Diagnosing Depressive symptoms in Primary Care/Outpatient Signs and Symptoms of Depression Depressed mood and/or loss of interest or pleasure Sadness, tearfulness, guilt, pessimism, sense of failure, self-dislike, dissatisfaction, irritability, social withdrawal, self-harm, apathy, lack of pleasurable activities. Physical/vegetative symptoms Trouble sleeping or sleeping too much (includes early morning awakening), trouble concentrating, decreased energy, decreased sexual interest, loss of appetite, overeating, digestive problems, constipation, bowel irregularities, aches and pains Physical/vegetative signs Disheveled appearance, difficulty sitting still, restlessness, slowed speech, movements and reactions. C. Conditions Characterized by Depressive Symptoms (1) MAJOR DEPRESSION Diagnostic Criteria for Major Depression (DSM -IV) Major depression is present when the patient has had 5 of the 9 symptoms listed below for at least two weeks. One of the symptoms must be either item 1 or Depressed mood 3. Significant change in weight or appetite OR 4. Insomnia or hypersomnia 2. Loss of interest or pleasure 5. Psychomotor agitation or retardation 6. Fatigue or loss of energy 7. Feelings of worthlessness or guilt 8. Impaired concentration or ability to make decisions 9. Thoughts of suicide or self-harm 14

16 (2) DYSTHYMIA Diagnostic Criteria for Dysthymia/Chronic Depression (DSM-IV) 1. Patients with Dysthymia/Chronic Depression are in a depressed mood: for most of the day for more days than not for at least 2 years with lapses lasting not more than 2 months 2. During periods of depression*, the patient has had two or more of these symptoms: loss of self-esteem insomnia or hypersomnia feelings of hopelessness poor concentration or difficulty making decisions low energy or fatigue poor appetite or overeating TREATMENT: Dysthymia/Chronic depression can usually be treated the same as major depression, except that the patient will require a full dose of medication for at least 2 years (maintenance therapy). * Not including episodes of mania or depression relating to substance abuse. Can coexist with episodes of major depression. (3) ADJUSTMENT DISORDER Diagnostic Criteria for Adjustment Disorders (DSM -IV) Patients with Adjustment Disorders do not meet criteria for major depression, dysthymia, bereavement or other major affective mental disorders. The patient has developed emotional symptoms out of proportion to what might be expected, or is experiencing worsened social or occupational functioning in response to (an) identifiable stressor(s). The symptoms must arise within 3 months of the onset of the stressor(s). TREATMENT: Patients may be treated with supportive counseling and stress reduction. Re-evaluate in 1-2 months. (4) MINOR DEPRESSION Diagnostic Criteria for Minor Depression (DSM -IV) The patient has had 2 to 4 of the 9 symptoms listed for major depression for at least two weeks (with one of the symptoms being either item 1 or 2). TREATMENT: Patients should be educated and counseled about depression, then re-evaluated in 1 to 2 months. They may improve with supportive counseling and watchful waiting and they may not require medication or a full-course of psychotherapy unless complicating features are present or depression worsens. (5) BEREAVEMENT 15

17 Diagnostic Criteria for Bereavement (DSM-IV) The patient s symptoms are associated with the loss of a loved one that has occurred during the past two months. The patient may or may not meet the symptom criteria for Major Depression. TREATMENT: Patients usually should not be treated with medications or fullcourse psychotherapy unless they are severely vegetative (severe lack of sleep, appetite, energy), suicidal or psychotic. Patients should be treated with supportive counseling and close medical follow-up. Patients who still meet criteria for major depression 2 months after a loss should be treated for major depression. 16

18 D. Patient Information about Antidepressant Medications 1. How do antidepressants work? Both life stresses and medical problems can change chemical messengers in the brain that maintain the balance in how you feel emotionally and physically. This chemical imbalance results in some of the common symptoms of depression such as sleep and appetite problems, loss of energy, poor concentration, and greater sensitivity to pain. Antidepressant medications can help restore a normal balance of these chemical messengers, which helps to relieve emotional and physical symptoms. Antidepressants can take up to 8 weeks to work. It usually takes two to four weeks until people start feeling better emotionally and physically. The improvement may be gradual, and often family members or friends may notice a difference in how you are doing before you do. Your sleep and appetite may improve first, and your mood, energy, and negative thinking may take some more time to improve. Once you are feeling better, do not stop the medication right away. Your doctor may recommend taking the medication for six to nine months or longer to prevent a relapse of the depression. 2. How to find an antidepressant that works for you Scientific studies show that antidepressant medications do not differ in the percentage of patients that get better. However, different medications are effective for different people, and the side effects of the medications differ. Some medications also cost more than others. Your doctor can help you decide which medication may be best for you. Between 50 and 80 % of patients will get better after 4 to 8 weeks on an antidepressant medication. By working together, you and your doctor can decide whether the medication you started is the right one for you. If you need to switch to another antidepressant because of side effects or because you are not improving, chances are excellent that you will improve on a second medication. 3. What about side effects? Some people may experience side effects when taking antidepressant medications. While these side effects can be annoying, they are rarely dangerous to your health. They usually occur in the first few weeks and then gradually decrease as your body adapts to the medication. Because of these early side effects, patients sometimes feel a little worse before they start getting better and may give up too soon. If you have side effects that are bothering you, discuss these with your doctor or your depression clinical specialist. Your doctor will help you determine if these side effects will decrease over time or if you should decrease or switch your medication. Some of the side effects that can occur with antidepressants include Nausea Headaches Jitteriness Weight gain Diarrhea Insomnia Sedation Urinary hesitancy dizziness rapid heart rate temporary difficulty in achieving orgasm blurred vision dry mouth constipation other: Remember: 1. Take the medications daily 2. Keep track of side effects and discuss them with your physician. 3. Antidepressants are not addicting or habit forming. They do not make people high, and they do not lead to serious withdrawal symptoms once you stop them. 4. It may take 2-10 weeks to feel the full benefits of antidepressants. 5. Continue to take the medication even when you feel better. 6. Don t stop the medications before talking with your primary care provider. 17

19 E. Common Questions about Treatments for Depression Questions about antidepressant medications 1. How do antidepressants work? Antidepressants help restore the correct balance of certain chemicals called neurotransmitters in the brain. 2. My problem is inability to sleep. How can an antidepressant help with this? In many cases, poor sleep is a by-product of a major depression. Once the depression lifts, sleep often improves as well. Antidepressants can help restore normal sleep, even in people who do not have major depression. They are advantageous over other sleeping pills in that they are not habitforming, and they usually do not impair concentration or coordination. 3. I have a problem with pain. How can an antidepressant help with this? Some antidepressants have been shown to be successful (even in the absence of major depression) in a number of pain conditions such as diabetic neuropathy, postherpetic neuralgia, and limb pain, headaches, back pain, and irritable bowels. Antidepressants may also help restore normal sleep and reverse a vicious cycle of pain and poor sleep. 4. I have low energy and feel tired a lot of the time. How can an antidepressant help with this? Low energy and fatigue commonly occur in people with major depression. Once the depression improves, their energy starts to return as well. Antidepressants can help restore energy in patients who are depressed. With successful treatment, patients will feel less tired and more able to do their usual activities. 5. I have a lot of stress in my life. How can an antidepressant help with this? Life stress can cause or worsen the symptoms of depression. The depression can then worsen the impact of such stressors (such as work stress, family problems, physical disabilities or financial worries) and your ability to cope with them. Treating the depression can help some patients break out of this vicious circle. 6. Are antidepressants addictive? No. Antidepressants are not habit-forming or addictive. They do not produce a high feeling, but slowly alter the amount of certain chemicals called neurotransmitters in the brain over a number of weeks. Restoring the levels to a more normal balance usually brings the depression under control. Some people have been taking antidepressants continually for up to 30 years without any significant (physical or psychological) adverse effects. 7. My problem is anxiety or panic attacks, not depression. How can antidepressants help? In many cases, anxiety is a by-product of depression. Once the depression lifts, the anxiety improves as well. Some antidepressant medications are also among the most effective medical treatments for anxiety disorders, including panic disorder and generalized anxiety disorder. 18

20 8. How long will it take the medications to work? It usually takes from one to six weeks for patients to start feeling better. In many cases, sleep and appetite improve first. It may take a little longer for your mood, energy, and negative thinking to improve. If the depression has not improved after 4 to 6 weeks, you may need an increase in the dose or a change to another antidepressant. 9. How long will I have to take the medication? Once you are completely recovered from your depressive episode, you should stay on the medication for another 6 months to prevent a relapse. Some patients who have had previous depressive episodes or are otherwise at high risk for a recurrence should be kept on a maintenance dose of antidepressants for longer periods of time. 10. Are there any dangerous side effects? Side effects from antidepressants are usually mild. You should ask your doctor or depression clinical specialist (who will coordinate with your doctor) what to expect and what to do if you have a problem. In many cases, your body will get used to the medication and you won t be bothered with the side effect for long. In other cases, your doctor may suggest that you lower the dose, add another medication, or change to another antidepressant. If used properly, there are no dangerous or life-threatening side effects. 11. Is it safe to take antidepressants together with alcohol or other medications? In general, antidepressants can safely be taken with other medications. You should let your doctor or depression clinical specialist know exactly which other medications (including over the counter medications) you are taking so that he/she can make sure that there are no problems. Antidepressants can increase the sedating effects of alcohol. Be careful to avoid excessive alcohol intake while on these medications. 12. What should I do if I miss the medication one day? Don t double up and take the dose you forgot. Just keep taking your medication as prescribed each day. 13. Can I stop the medication once I am feeling better? No. You would be at high risk for having the depression come back, and may experience some temporary withdrawal symptoms. After one episode of depression, there is a 50 % risk that the depression will return. After two episodes, the risk goes to 70%; and after three episodes, the chances are 90 % that you will have a recurrence if you stop using the medication. In most cases, you should continue the medication for at least 6 months after you and your doctor agree that your recovery is complete. DON T STOP THE MEDICATION BEFORE DISCUSSING IT WITH YOUR PHYSICIAN OR IMPACT CARE MANAGER. 14. Will I get better? With adequate treatment, between 50 and 80 % of patients will have a complete recovery. Should you not respond to the first antidepressant treatment you try, there is an excellent chance that you will respond favorably to another medication or to psychotherapy. 19

21 Questions about Problem Solving Treatment (PST): 1. What is PST? Problem-Solving Treatment (PST) is a brief form of psychotherapy that teaches people how to solve the problems that are making them depressed. You will meet with your treatment specialist for 16 weeks, and during that time you will learn seven steps to fix the problems that are bothering you. 2. Four to sixteen weeks seems awfully short. How can I solve all my problems in so few meetings? The goal of PST is to teach you how to solve problems on your own. You will not be expected to solve all your problems during this time. But, you will get to solve a few problems. By working on some of your problems in the 16 weeks you have with your treatment specialist, you will learn to solve other problems in your life on your own. 3. Four to sixteen weeks seems awfully long to learn how to solve problems. Do I have to go to every one of those meetings? Learning how to solve problems is not easy. You will want to practice the skills you are being taught. Although you do not have to use all 16 meetings, you will want to work with your treatment specialist at least 4 times to learn PST. 4. Do I have to tell my TS everything? Most people have a hard time talking about their problems to people they don t know. While it is important to talk about all the major problems that you think are related to your depression, you don t have to talk about every problem you have. Because the goal of PST is to TEACH you how to solve problems on your own, you can learn PST by focusing on any problem you feel comfortable discussing. 5. Do I have to talk about my mother? Not unless she is currently one of your problems. PST focuses on problems you are having now, not your childhood. 6. Homework? What if I don t do my homework? We encourage you to practice your new skills outside of the meetings. Try and do your homework! You will not be graded, but even if you don t finish your homework, plan on coming anyway. We want to see you. 20

22 F. Guidelines for Using Antidepressant Medications 1. Antidepressant Medication Dosing a. Serotonin Reuptake Inhibitors (SSRIs) Common side effects in all SSRIs (> 10 %): insomnia, restlessness, agitation, fine tremor, GI symptoms (nausea, headache), dizziness, sexual dysfunction. Drug Name Unit doses available (in mg) Therapeutic dosage range (mg) Usual dose (mg) Starting dose in elderly patients (mg) 1. Sertraline 50, Citalopram 10, Few drug interactions. b. Other Antidepressants a Comments and common side effects-specific to this drug in addition to common side effects described above Drug Name 1. Bupropion XL Unit doses available (in mg) (SR) 150, 300 (XL) Therapeutic dosage range (mg) bid-tid (XL) Usual dose (mg) bid (SR) (XL) Starting dose in elderly patients (mg) 100 qd (SR) Comments and common side effects-specific to this drug Insomnia/agitation. Risk of seizures at high doses b Once or twice daily dosing with SR preparation. b Bupropion should be avoided in patients with a history of bulimia, seizures, or with significant head trauma or CNS lesions that put the patient at higher risk for seizures. 2. Titrating Commonly Used Antidepressants Name Starting dose in mg Increase as needed and as tolerated (doses in mg / day) High / target doses c Citalopram 10 qam Increase to 20 mg within 1 wk 40 as tolerated. Sertraline 25 qam Increase to 50 mg within 1wk as tolerated To 100 mg within 3 wks To 150 mg within 6 wks 150 Bupropion SR or XL SR: 100 qam XL: 150 mg QAM Increase to 100 bid after 1 wk To 150 bid (or 300 od for XL) after 2 wks to 150 tid after 6 wks 450 c Most patients will respond to lower doses and will not require such high doses, but patients with partial responses to lower doses should be titrated up to these maximum doses as tolerated. d Different titration schedules apply for sustained release preparations. 21

23 3. Guidelines for Switching Antidepressants Abrupt discontinuation of short acting antidepressants can lead to an uncomfortable antidepressant withdrawal syndrome. The following is a rough guide to switching antidepressants. Switching from SSRI to SSRI: One can usually switch from one SSRI to another without much difficulty. 4. Rates of SSRI Antidepressant Side Effects across Clinical Trials a Adverse effect SSRI rate Adverse effects more common in SSRIs Diarrhea 12 % Headache 15 % Insomnia 13 % Adverse effects more common in TCAs Blurred vision 6 % Constipation 8 % Dizziness 8 % Dry mouth 18 % Tremors 7 % Urinary disturbance 3 % a John W. Williams, MD, MHS, Personal Communication 5. Strategies for Managing Antidepressant Side Effects a. General Strategies: 1. Explore whether the side effects are physical or psychological? 2. Wait and support. Many side effects (i.e., GI depressive symptoms with SSRIs) will subside over 1-2 weeks of treatment. 3. Lower the dose (temporarily). 4. Treat the side effects (see below). 5. Change to a different antidepressant. 6. Change to or add PST. b. Treatment Strategies for Specific Side Effects: Sedation - Give medication at bedtime - Try caffeine Orthostatic hypotension /dizziness Anticholinergic (dry mouth/eyes, constipation, urinary retention, tachycardia) - Consider switching to a different antidepressant - Adequate hydration - Sit-stand-get up slowly - Support hose - Consider switching to a different antidepressant - Hydration - Sugarless gum/candy - Dietary fiber - Artificial tears - Bethanechol mg bid tid - For confusion stop medication and rule out other causes GI symptoms / nausea - This often improves or resolves over 1-2 weeks - Take with meals 22

24 - Consider antacids or H2 blockers Activation / jitters / tremors - Start with small doses (especially with underlying anxiety disorder) - Reduce dose - Try beta blocker (propranolol mg bid / tid) - Consider short term trial of benzodiazepine Headache - Lower dose - Try acetaminophen Insomnia - Trazodone mg po qhs (can cause orthostatic hypotension and priapism) - Make sure activating antidepressants are taken in a.m. Sexual dysfunction - May be part of depression or medical disorders - Consider switch to bupropion, nefazodone, or mirtazapine - Decrease dose - Try adding bupropion 75 mg qhs or bid - Try adding buspirone mg bid - Try adding cyproheptadine 4 mg 1-2 hrs before intercourse - Consider a trial of sildenafil, tadalafil, or vardenafil in consultation with PCP or urologist 6. Antidepressant Drug Interactions All antidepressants are metabolized by the P450 isoenzyme system in the liver. Certain antidepressants inhibit specific subtypes of P450 enzymes and this may increase blood levels in patients who are taking other medications metabolized by the same isoenzyme systems. Care is advised in patients who are taking medications with a narrow therapeutic window such as digoxin, warfarin, anticonvulsants, or theophylline. It is advised to observe clinically for side effects from such medications and to recheck serum blood levels of such medications as the dose of the antidepressant is titrated upwards. Please refer to the medication package insert, a pharmacology text, or consult with your team psychiatrist or a pharmacist if you have questions about specific drug-drug interactions involving antidepressants. 7. Troubleshooting: What to Do if Patients Don t Improve as Expected Common problem Possible Solution 1. Wrong diagnosis Reconsider diagnosis and differential diagnosis Consider psychiatric consultation 2. Insufficient dose Increase dose 3. Insufficient length of treatment (Remember: it may take 8-10 weeks for patients to respond to treatment) Support and encourage patient to stay on medication for a full trial (8-10 weeks) at a therapeutic dose. 4. Problems with adherence Try to understand the patient s perspective and concerns Address barriers to adherence and problem-solve together Consider serum drug levels if using tricyclic antidepressants 5. Side effects (Remember: side effects may be physiological or psychological) Wait and reassure patient - the body often gets used to them (e.g., GI side effects from SSRIs or SNRIs) Reduce dose 23

25 Treat side effect(s) Change medication See Strategies for Managing Antidepressant Side Effects section 5(F5) 6. Other complicating factors a. psychosocial stressors / barriers b. medical problems / medications c. psychological barriers (low self esteem, guilt, unwillingness to let go of sick role) d. active substance abuse e. other psychiatric problems 7. Treatment is not effective despite adequate trial of medication at adequate dose Address problems directly Consider psychiatric consultation Consider adding psychotherapy Psychiatric consultation for difficult to treat depression 24

26 6. DOCUMENTING AND TRACKING CLINICAL ENCOUNTERS The Treatment Specialist completes an Evaluation Form at each clinical encounter (see Appendix E). At the weekly clinical team meetings, the Treatment Specialists will discuss their current study patients. The log (see Appendix E) should be completed and brought to these meetings to facilitate discussion. 25

27 7. APPENDICES APPENDIX A: GUIDELINES TO TALKING TO PATIENTS AND CAREGIVERS ABOUT DEPRESSIVE SYMPTOMS Working with older adults experiencing depressive symptoms: This appendix provides an introduction to working with older adults who are experiencing depressive symptoms. In order to help empower each patient to be an active participant in his/her treatment, the establishment of a good working relationship with the patient is very important. Older adults who with adjustment problems often feel isolated and alone and do not have the energy to seek help. The effect of having someone seek them out, explore with them their symptoms and their attempts to cope, offer help, and encourage them to pursue effective treatment can be quite powerful. Through the relationship with the patient, the TS does more than coordinate appointments and assess needs. He or she provides a crucial and therapeutic force in a patient s ongoing treatment. During the initial contacts, the TS should communicate his or her enthusiasm and interest in the patient s well being. In the initial session, the patient should begin to understand that the TS is someone with whom he or she will be in ongoing contact. This person will know the particulars of the patient s situation and can help access resources provided within the CODIACS model and communicate with the rest of the care team. It is very important to establish oneself as an empathic person who is trustworthy and capable and who works collaboratively with the patient s treaters and the rest of the research treatment team. Empathic encouragement can make a difference in getting a patient through rough spots such as being discouraged by the slowness of treatment effects. The TS can help the patient stay clear about what the goals are and support the patient s efforts to reach them. It is very important to understand each patient s perspective. Creating a good fit between the clinician s and the patient s understanding of depressive symptoms is essential for treatment success. Try to listen and talk with the patient in uncomplicated and non-judgmental terms. Attempt to understand the patient s explanatory model (i.e., his / her perspective on the cause of the disorder, expected evaluation and treatment, benefits of various treatments, risks and harms associated with treating or not treating the disorder). This will allow the patient to feel part of the treatment team and increase his or her likelihood of treatment adherence. The cycle of depressive symptoms model (below) can be helpful in discussions with patients. It points out that depressive symptoms comprise a complex syndrome that involves thoughts and feelings, behaviors, and physical symptoms. While many patients are troubled by negative thoughts and feelings of sadness or hopelessness, others are most aware of physical symptoms such as pain, low energy, poor sleep, poor appetite or overeating, and feeling agitated or slowed down. The model points out that medical problems or other life stressors can worsen depressive symptoms. This can also result in problems with sleep and appetite, loss of energy, and loss of concentration. Depressive symptoms can interfere with sleep, which can in turn worsen the patient s ability to cope with these problems. The good news is that this downward spiral may be reversible with behavioral activation, such as a guided exercise program, with certain forms of psychotherapy, and/or with medication. These treatments can help to improve a person s coping skills, restore normal sleep, and help with pain, fatigue, and poor concentration. When patients feel more rested, it is easier to enjoy one s daily work and activities. Engaging in more pleasant activities gives one a sense of accomplishment and helps one start to think more positively and climb back out of the depth of depression. 26

28 The Cycle of Depressive symptoms Stressors medical illness, work or family problems Thoughts and Feelings negative thoughts, low self esteem, sadness, h l DEPRESSIVE SYMPTOMS Physical Problems pain, low energy, poor sleep, poor concentration Behavior decreased physical or social activity, decreased productivity, alcohol or drug use In discussing depressive symptoms with patients, it can be helpful to mention that: - depressive symptoms or depressive symptoms are common in patients after ACS - depressive symptoms can cause a wide spectrum of depressive symptoms including physical symptoms such as low energy, fatigue, lack of appetite or overeating, and poor sleep - depressive symptoms affect our body, our behaviors, and our thoughts - depressive symptoms are a real problem, not a character defect or weakness. The symptoms are not in one s head but real physical experiences. - the good news is that depressive symptoms may be treated either with psychotherapy or with antidepressant medications - patients can learn skills to cope with depressive symptoms and their causes - physical activity / exercise are often helpful for depressive symptoms, but patients are often afraid that such activities may cause injury or pain, especially after an ACS - minor tranquilizers (such as benzodiazepines), drugs, and alcohol can make depressive symptoms worse, and lead to episodes of major depression Working with difficult patients: At times, the TS may find that he or she does not feel as effective as he / she would like to be with some patients or may find it difficult to work with certain patients. The TS should discuss these concerns during weekly clinical team meetings in order to get support and to avoid any negative outcomes for either the TS or the patient. Usually, having a chance to explore one s own reactions with a skilled colleague can help future interactions with the patient go more smoothly. Working with older adults: One common detriment to working with older people is the fact that it can sometimes take twice as long to educate an older patient about his or her care than it takes to educate a younger patient. This is due to the fact that the interaction of age and depressive symptoms can make it harder for patients to process new information. In addition, older persons with depressive symptoms have a harder time keeping focused, and can often use up time answering your questions by telling you long stories about their lives. While the social support they gain from your listening to their story is helpful to them, it is only helpful in the short run and prevents you from truly helping them learn about depression and the various ways they can manage their disorder. There are three basic strategies that you can employ to help you make the most of the limited time you have with your older patient. 27

29 Setting the agenda. Whenever you meet with your older patient, whether it is by phone or in person, you should always begin the meeting by informing the patient about the time limit for the meeting, and what you both should cover during the time you have. Always start by telling them how much time you have to meet, the things you would like to cover, and then asking them what questions or topics they want to discuss. After getting that information, assign approximate times limits to each topic ( How about we spend about 5 minutes talking about the side effects you mentioned and then ten minutes talking about St. John s Wort.) This strategy not only focuses the patient, but also allows you to use your time efficiently. If you don t cover everything, you can then add the topics you did not cover to your agenda for the next visit, making the patient feel that you will address all their issues. Repetition and writing. As mentioned above, older people take longer to learn new information. A good rule of thumb in teaching older people new information is to tell them the new information a couple of times and in different ways. For instance, when educating a patient about depressive symptoms, break down the information into small sections. After discussing one section, summarize what you have just told them, and ask them questions about the information you just taught them. Also have the patient write down what you are telling them, either on the materials you hand them or in a notebook. This procedure helps them focus on the content of what you are telling them, increasing the likelihood that they will remember the information. At the end of each meeting, review all the topics you discussed and all the solutions developed, so that they have yet another chance to hear what you want to tell them. Refocusing. One of the hardest things to do is to interrupt older persons in the middle of their stories. It is very common to feel like you are their only source of support and that it is disrespectful to interrupt. In truth, you do your older patients a greater disservice by not refocusing them. An older person could potentially take up a majority of the meeting time, leaving you very little time to go over the education you need to provide. Reminding patients of the time limits you have, setting an agenda early in the meeting, and gently interrupting patients are useful refocusing tools. Working with minority elderly: When working with an older person, one must always be mindful of that person s cultural background. Being familiar with a patient s cultural beliefs about medicine and adjustment will help you to communicate with your patient and will increase the probability your patients will adhere to treatment. While it is impossible to know all the nuances of each culture, there are still overarching themes you can keep in mind when working with older minorities. These are respect, family support, distrust of white organizations, stigma, spirituality, access barriers, and acculturation. Respect. In many ethnic communities, older adults are seen as sources of wisdom, teachers and moral examples. Because of this perception, it can be very difficult for an older person to discuss problems with you, or admit to you that they are having depressive symptoms, for fear of losing your and their family s respect. This is particularly true for Latinos and Asians, and for African American women, who are often seen as the family cornerstone. You can engage patients in treatment by discussing how depressive symptoms have impacted their relationship with the community and their family and by helping them understand that treating their depressive symptoms will give them more energy to be there for their children, grandchildren and community. The concept of respect can also be a deterrent to treatment. Sometimes, older minorities will try to be respectful of their doctor and will not complain to you about medication side effects or lack of effectiveness of treatment. They may see any complaints about their treatment as being disrespectful. It is therefore important to explain that you are asking questions about side effects and response to help treat the patient s depressive symptoms. It is also important to say you want to know about any problems because treatments sometimes need to be adjusted or changed. This information will help the patient feel less anxious about being disrespectful. 28

30 Family support. In many cultures, when the identified patient cannot take care of him or herself, or the family suspects the patient needs help with medical care, there will be an identified family member who will usually make all the patient s appointments, will want to sit in on the visits, and will be responsible for making sure the patient adheres to treatment recommendations. This person will also function as the patient s gatekeeper, screening all research-related issues. When this is the case, this person must be involved in all aspects of the patient s care (with the exception of PST, which is discussed in the PST manual). This person will most likely be the family member who accompanies the patient to the first visit, but you should always make sure by asking the patient Is this the person who handles all your appointments and medicines? Because of the reasons discussed in the respect section above, you should always explain to the family member that you would like to spend a few moments alone with your patient to get to know him or her. This allows the patient some private time to talk about any problems s/he does not want the family to know about. Distrust. It can sometimes take a long time to establish a relationship with minority patients, particularly if you are seen as part of a research project, rather than the treatment team. African Americans have often mistreated in medical studies. Clear communication, transparency, and explanations of benefits and limits of research should be provided at all times. Stigma. In working with minority elderly, it is important to discuss with them their beliefs and attitudes about adjustment problems and any fears they may have about people in their community finding out they are in treatment for depressive symptoms. Much of the cultural stigma around this can be addressed through the use of psychoeducational materials. However, do not simply hand the patient or the family member the materials and expect them to read it. Go over all the information in the office and discuss any questions. For those patients who are fearful of losing respect, offer to hold the materials for them so that they can read them over at each visit. Also, the use of overly processed or glossy materials can make the patient feel the treatment is impersonal. You can personalize the materials for them by writing on the pamphlets and highlighting the points in the materials the patient feels were important to learn. Spirituality. Religion and spirituality in older minorities are often very important components of the culture. A good way to assess for improvement or worsening of depression is to assess the patient s level of activity in the church community. For African Americans and Latinos, the use of prayer is often a very important coping mechanism and can be encouraged when patients indicate they are no longer employing this practice. In traditional Latino communities, spirituality may also involve the use of healing herbs and remedios, and visits to a curandero are not uncommon. When asking about medicines the older person is taking, it is also important to ask about the use of botanicos and other herbal remedies. It is also important to respect the use of these herbs. If you try to get a patient to choose between the antidepressant and the herb, the antidepressant will always lose. Keep in mind that not all Latinos and Asians use herbal remedies. However, older Latinos are more likely to use these preparations than younger Latinos, so it is important to at least assess their use. Access barriers. Many minority elderly have trouble making regular appointments because of the many demands on their time. In addition to their own doctor visits, minority elderly, women in particular, take care of grandchildren or spouses and will often put the needs of their family before their own needs. Time then is important, and as a provider you must remain flexible, but also encourage the patient to look after himself or herself. A helpful technique in getting older minority women to attend to their own needs is to educate them about how spending time on themselves makes them stronger and more able to manage their family demands. You can t fill someone else s cup unless your cup is full. Other access barriers include transportation and finances. In considering the frequency of treatment visits, you should also assess how long it takes patients to get to the clinic and how difficult it would be to arrange transportation. Cost of care is also important to consider since minorities are often on fixed incomes and will not adhere to treatment if the most expensive medication on their list is the antidepressant. Acculturation. There are no hard and fast rules for working with older minorities. How you work with older minority individuals will depend in large part on how acculturated they are and to what degree they feel connected to their ethnic community. Before assuming that any of the issues discussed above is true for your 29

31 Hispanic, Asian or Black patient, get to know the person first. If he or she was never religious, recommending prayer will only offend the patient. Make sure you spend some time talking to the patient about the issues discussed above, so that you can deliver culturally appropriate care. Working with family members and significant others: In most cases, it will be very helpful for the TS to involve family members or significant others in the treatment of a patient with depressive symptoms. The TS should always discuss with the patient how family members and significant others will feel about them being treated by the study. The TS may encourage the patient to share educational materials with significant others or suggest talking to or meeting with important family members to do some education about depressive symptoms, and to ask them to support the patient s treatment plan. This could include help with adherence to antidepressant medications or with plans made during PST training. See also the section on family support in the section on working with minority elderly (above). 30

32 APPENDIX B: PSYCHIATRIC EVALUATION FOR PERSISTENT DEPRESSION Psychiatric evaluations for persistent depression have two major objectives: (1) to clarify the diagnosis including psychiatric disorders and comorbid medical problems or medications that should be considered in developing a treatment plan (2) to develop a treatment plan for Step 2 or 3 and, when indicated, to initiate treatment in cooperation with the TS and the patient s cardiologic care provider. The following table lists a number of factors to explore during an initial consultation. The results of such consultations should be documented by the team psychiatrist using the Treatment Change Form (see Appendix E), which provides a brief assessment, diagnosis, and specific treatment recommendations as well as recommendations for follow-up. 1. Evaluate for other psychiatric disorders - Major depression - dysthymia - bipolar disorder - panic disorder - obsessive compulsive disorder - PTSD - Anxiety disorder - psychotic disorders or psychosis - dementia - delirium - other cognitive problem - somatization or somatoform disorders - alcohol / substance abuse (including prescription drugs) - family history of depression 2. Consider medical disorders or medications that may contribute to a depressive syndrome - Hypothyroidism or hyperthyroidism - Hyperadrenocorticalism - Hyperparathyroidism - Hypokalemia, hyponatremia - Parkinson s disease, recent stroke, and other neurologic disorders - Cerebrovascular disease - Sleep apnea - Cancer - Congestive heart failure - B12 deficiency - Chronic pain syndromes - Other neurologic disorders - Steroids - Recent start of a beta blocker - Antineoplastic agents - Narcotics - Benzodiazepines - Other sedatives - Alcohol - Stimulant withdrawal 3. Explore prior treatment history - adequacy of treatments attempted 31

33 - attitudes towards treatments and treating providers - successes - failures - relevant treatment history in close relatives 4. Address problems with adherence - different explanatory model patient does not feel understood - cultural barriers - dynamic barriers (dependence, secondary gain, other) - life stressors (caregiving, unresolved grief, other) - instrumental barriers (money, transportation, time) - cognitive impairment - treatment regimen is too complex - side effects - patient is discouraged and feels treatment will not work 32

34 APPENDIX C: RESOURCES FOR THE TREATMENT SPECIALIST (TS) 1. SCRIPT FOR INITIAL TELEPHONE CALL 1. Introduce yourself Good (morning / afternoon / evening), M(r/s).. I am, a treatment specialist at the clinic. 2. Explain how you obtained the patient s name I work with [name of study coordinator] who has spoken with you about our treatment study for depressive symptoms in patients who have had a cardiac event. 3. Explain purpose of call (scheduling visit) I would like to schedule you to come in for a visit with me in the clinic. 4. Explain the nature of the initial visit During this visit, I want to talk a little bit more with you about some of the symptoms you have been experiencing. The information should help you and your doctor decide about whether you need treatment, and if so, what the right treatment is for your symptoms. I would also like to give you some information that tells you more about our treatment program. 5. Wait for feedback, if none, continue: Do you have any questions at this time? 6. Schedule visit if none has been scheduled When would be a good time for you to come to the clinic? (Arrange a visit time and meeting place) 7. Thank patient and provide contact telephone number Thank you very much. I look forward to meeting you on (date/time). If you have any questions between now and our visit, feel free to call me at (TS s telephone number). 33

35 2. GUIDE FOR THE INITIAL VISIT The initial visit consists of meeting the patient, addressing any questions or concerns he or she may have about depressive symptoms or CODIACS care, and reviewing the educational brochure together with the patient. This is a collaborative process during which the UC and the patient review the brochure together, discuss pertinent details and assess how the patient has been affected by specific symptoms of depression. They also discuss preferences for treatment and treatments available. During this review of the patient brochure, the UC also conducts a patient assessment, which is documented on the Evaluation Form (see Appendix E) as the session proceeds. a. Goals for the initial visit: 1. Educate the patient. Learn about the patient s views regarding depressive symptoms by reviewing the patient education brochure together with the patient. Assess whether the patient has the following: Current symptoms suggestive of depression. (Review BDI and complete PHQ-9 with patient) A history of depression or treatment for depression. A family history of depression. Coexisting psychiatric, medical, or psychosocial problems that may cause depressive symptoms Impaired social, personal, family, or work functioning Low social support or involved family/friends who should to be taken into account Strong pre-existing treatment preferences 2. Identify at least two questions that the patient would like to ask. 3. Document your findings on the Evaluation Form (see Appendix E) b. Guidelines for conducting the initial Visit During the initial visit you should try not to advocate excessively for the patient; you want to get the patient to become an advocate for themselves. you should try not to provide information that is outside the domain of depression and depressive symptoms. For any but the most basic questions, refer the patient to other sources of information. You may say to the patient, for example: That s an excellent question, and it s something your doctor will want to know that you are concerned about. Let s note it here OR That s something we deal with in the brochure, let s look at this together... c. Initial assessment queries helpful in completing the Evaluation Form The initial TS assessment is guided by an understanding of the key features of depression, but follows the TS s judgment about which areas to explore in detail during the limited time available. The following probes may be useful in framing questions to gather information required by the CODIACS Evaluation Form. Questions for the cardiologic care provider: Pick up important questions as the interview progresses. Ask the patient what he/she most wants to ask their doctor at the end of the interview, and be prepared to feed back earlier questions to the patient as possible targets if the patient cannot tell you in answer to your direct request. You should list at least two questions. Symptoms of depression and other psychiatric disorders: To assess for sadness: How much time in the past month have you been feeling down or depressed? Did you feel so down in the dumps that nothing could cheer you up? To assess for mania: Have you ever had a period of four or more days when you were so happy or excited that you got into trouble, or your family or friends worried about you, or a doctor said you were manic? Have 34

36 you ever had a period when you were much more active than usual, or felt that you hardly needed to sleep at all but did not feel tired or sleepy? Did a doctor ever prescribe Lithium for you? (Mania is a study rule-out.) To assess for suicidality: Do you ever have thoughts of wishing you were dead? Have you actively thought of killing or hurting yourself? What have you thought of doing? Are you having such thoughts now? Refer to your team s plan for handling psychiatric emergencies if a patient endorses active thoughts or plans of suicide. To assess for somatic symptoms: Look especially for stomach or intestinal complaints (abdominal pain, constipation); musculoskeletal complaints (back pain, shoulder/neck pain); palpitations; dizziness / lightheadedness; weakness. To assess for alcohol or drug use: How many alcoholic drinks do you have on a typical day? What is the most that you ever drink at one time? Do you ever feel the need to cut down your use of alcohol? Have you been annoyed by others criticism of your drinking? Have you ever had a blackout? Alcohol/substance use/abuse disorders are study rule-outs. Activities affected To assess social, personal, family, and work activities, and bed or restricted activity days: Does the person participate in social and community activities (religious, family, friends)? Has social activity decreased from the past? Does the person have difficulty performing family responsibilities? Does the person have trouble fulfilling job responsibilities? Does the person have days when s/he doesn t get out of bed (bed days)? Does the patient have days when s/he cuts down on the things they usually do for half a day or more (restricted days)? Social stressors To assess for stress: Consider losses (deaths, separation or divorce, recent surgery, new health problems in self or significant others, children leaving home); job loss or change, moving, past history of physical or sexual abuse. Social Support To assess for social support: How many friends or relatives do you see or hear from at least once a month? Which friends or relatives do you have the most contact with? Do you talk to any of these people about private matters? Do you ask any of them for advice on private matters? Treatment Preferences Ask the patient whether he/she would have objections to being treated with a course of Problem Solving Treatment or with antidepressant medication. Determine if the patient has any specific objections or concerns regarding either treatment option. Work with the patient to help them decide what their treatment preference is. Inquire also about other forms of treatments including alternative medications such as St. John s wort or ginko that the patient may be currently trying or that the patient would prefer at this point. 35

37 3. GUIDE TO MAKING A Relapse Prevention PLAN The goal of making a relapse prevention plan is to prevent a relapse or recurrence of symptoms as much as possible. A number of steps are involved in making a relapse prevention plan. a. Review the course of symptoms up to now and address the following: depressive symptoms and/or depression symptoms impact of the depressive symptoms on the patient s ability to function at home and at work current treatment(s) and treatment(s) tried before questions about treatment(s) b. Review risk factors for relapse. 1, or 2 or more prior episodes of depression dysthymia: chronic depressive symptoms for 2 years or more residual depressive symptoms (patient is not completely back to baseline) Remind the patient that these are risk factors for relapse of symptoms. We know from prior research that, without active treatment, 50% of patients with one prior episode of major depression will have a relapse within two years. Patients with 2 or 3 prior episodes have a 70 or 90% chance of relapse, respectively. Patients who have such risk factors should stay on full dose antidepressants for at least 2 years (if these have been used in CODIACS). Patients who don t have these risk factors should stay on antidepressants for 6-9 months after they achieve remission (if these have been used in CODIACS). After that, they can be tapered off medication over a week to a month and should monitor themselves for a recurrence of symptoms. You should also contact them one more time one month later to make sure that they have not relapsed off the medication. Patients who have reached a remission after a trial of PST should be encouraged to incorporate the strategies they have learned into their normal daily routine. c. Review the rationale for continuing medication or maintenance PST and encourage the patient to do so. Research has shown that full doses of antidepressants (i.e., the doses which resulted in the initial remission of symptoms) or ongoing maintenance psychotherapy significantly reduce the risk of relapse. In one study, 80 % of those on antidepressants stayed free of depression for 3 years compared to only 20 % of those taking a placebo. For some patients, medication maintenance treatment may be required indefinitely. Besides staying on medications, there are a number of other things patients can do to prevent a relapse of symptoms, and you will spend the rest of the session working on this. Get a sense of what might motivate the patient to stay on long term medication. Reinforce the patient s motivation to do so as much as possible. Be careful not to sound like you are trying to control the patient s behavior. Be empathic. Try to understand the patient s perspective and concerns. You may want to point out that the primary care provider and you want to help prevent a relapse, but it is up to the patient to continue in treatment. This is a decision you have to make yourself. Let the patient know that you believe he or she can take some action, which will significantly reduce their risk of relapse and give them more control over their health. If you sense resistance, carefully explore what may be difficult for the patient at this time. d. Review any concerns about continuing medications or psychotherapy and anticipate potential barriers. Start out with neutral question such as I wonder how you feel about taking your antidepressant medication long term? 36

38 Point out that up to 50% of patients with chronic medical illnesses have difficulty taking their medications as prescribed. Ask patients to generate a list of pros and cons of staying on medication long term, and to weigh these against the risks and benefits of stopping antidepressants. Patients may have a number of concerns about the long term use of antidepressants, and it is important to address these as much as possible. (See Section 5 (E), Commonly Asked Questions Regarding Antidepressants). e. Discuss early warning signs of depressive symptoms. Patients and significant others can learn to recognize such early warning signs and get help before relapses become severe. Common early warning signs include changes in sleep, appetite, or energy level, loss of interest in usual activities, irritability or withdrawal from others. These early warning signs differ from patient to patient. Patients or significant others may remember early signs of depression from their most recent episode. In many cases, spouses or significant others may notice such warning signs before a patient does, and it can be very helpful to involve them in the monitoring for such signs. f. Make a relapse prevention plan. It can be very discouraging to experience a recurrence of symptoms. If patients detect these symptoms early on, however, it may be easier to prevent a severe relapse. Encourage patients to think positively about seeking additional help for symptoms. Seeking such help should not be seen as a sign of failure, but as a positive step (i.e., I am doing something to take care of myself ). A relapse prevention plan for the patient includes early warning signs and a plan for what to do if you or a significant other notices such symptoms. The plan can include: discussing the situation with a close friend/relative making sure you are taking the medication as prescribed considering stressful life situations (problems at work, in one s family, etc.) which may lead to an exacerbation of symptoms and using the skills learned in PST to address them scheduling positive life events contacting the DCS contacting the cardiologic care provider or a psychotherapist who has been helpful in the past g. Discuss future clinic or telephone follow-up contacts. Tell the patient that you would like to schedule a telephone follow-up appointment once per month to make sure that he / she continues to do well. During these contacts, you will review depressive symptoms and see if the patient is still on treatment to prevent a relapse. Let the patient know that you will be in contact with his or her cardiologic care provider to let them know how the patient is doing. Schedule the first follow-up call 1 month after the relapse prevention visit. Encourage the patient to call you earlier if he or she has any questions from the relapse prevention. h. Remind patients that both you and the cardiologic care provider are available and how you can be reached. 37

39 4. PLAN FOR PSYCHIATRIC EMERGENCIES (insert site specific plans here, from Safety Manual) 5. Training Role Plays for Initial Assessment and Follow-up Case 1 Initial Visit Mrs. L is a 66 year old retired teacher and mother of 2 grown children who had her first ACS. She presents with lack of appetite, constipation, and insomnia since then. Mrs. L reports feeling hopeless, worthless, and lacking a sense of purpose. She attributes these feelings to the beginning of her retirement. She has recently ceased activities with her bridge club and swimming classes. Her husband is concerned about her crying spells and lack of interest in church activities and travel- things she had planned to devote time to after retirement. She cites fatigue as her reason for canceling a trip to Hawaii and states that she doesn t feel up to teaching (Sunday School) anymore. Mrs. L recalls no prior episodes of depression, however, her mother suffered from depression for several years. Case 1 1 week telephone follow-up Mrs. L has been taking Sertaline 50 mg po qd. She has not noticed any difference in her mood but has been troubled by some nausea during the daytime. Case 1 8 week clinic follow up Mrs. L is feeling significantly better. Her energy and appetite have increased and she is no longer experiencing insomnia regularly. She has resumed her many of her former activities and is planning a surprise anniversary trip to Europe for her and her husband. She is still taking Sertaline 50 mg but is wondering when she should discontinue using it. 38

40 Case 2 Initial Visit Mr. B is an 80 year old African-American man. A retired veterinarian, he is the father of 2 children and grandfather to 8. His wife died of cancer 10 years ago. Since his retirement 15 years ago he had remained active, working in the yard daily and helping to care for his grandchildren. However, since his ACS he has begun to complain of fatigue and has lost interest in most of the activities that previously occupied his days. He denies suffering depressive symptoms, focusing mainly on his physical problems, and has a history of diabetes to which he attributes his symptoms of fatigue, back pain, and lack of appetite. However, his children are concerned about his recent loss of motivation and will to live. He now spends the majority of his days in front of the TV and expresses little interest in his former hobbies, or even in playing with his grandchildren. When questioned about these changes, he states that he is just getting old. He says he has poor concentration, poor appetite, low energy, and he feels he is just getting in people s way. Case 2 1 week telephone follow-up Mr. B was given a prescription for sertraline 50 mg qd. He stopped taking it after 3 days because of side effects and lack of improvement in his symptoms. However, he soon resumed at the urging of his children who reminded him that the side effects would not last long and that it may take a few weeks to notice signs of improvement. Case 2 8 week clinic follow-up Mr. B has remained compliant with his medication since the telephone follow-up. He has not experienced any further side effects. He reports an increase in energy and appetite and states that his children seem pleased with his progress. He has begun working in the yard occasionally and spending time with his grandchildren again. 39

41 Case 3 Initial visit Mrs. S. is a 74-year-old Hispanic mother of three grown children. She presents with complaints of extreme fatigue and constipation since her ACS. Her children are concerned that she has cancer because she has lost 30 pounds in the past year, and her appetite is poor. She has been sleeping poorly because she has been caring for her husband who had a stroke two years ago and is bedridden. He is frequently incontinent and calls for her at night. She has considered placing him in a nursing home but just cannot bring herself to do this. Mrs. S. herself has significant other medical problems including a long history of hypothyroidism for which she is on replacement hormones. She also has hypertension and high cholesterol. When asked about prior episodes of depression, her daughter states that she had a severe depression after the birth of her second daughter, which required an inpatient admission and treatment with electroconvulsive therapy. She has bad memories of this episode and does not wish to see a psychiatrist because of this. She denies currently feeling depressed but says that she has been crying frequently, often for no good reason. She has stopped going out to see her friends because she feels she cannot leave her husband. Even when her children come over to help care for the husband, she does not feel like doing anything. Case 3 1 week follow-up Mrs. S. was given a prescription of sertraline 25 mg po qhs but has not started taking the medication. She cries on the telephone and states that she does not want to become dependent on a medication. She focuses on problems with her husband s incontinence and calling for her at night. Case 3 8 week clinic follow-up After the telephone follow-up, Mrs. S was enrolled in a course of Problem-Solving Treatment, since she continually delayed starting her antidepressant prescription. One of the first things she worked on with her therapist was to find someone to watch her husband several hours per day so she could go to the PST sessions and run some errands. She reports feeling more in control of her symptoms and has begun accepting more help from her children. However, insomnia and fatigue are still present. After further education on the risks and benefits of antidepressants, she has agreed to a trial period and was given enough samples to last until her next appointment. 40

42 PHQ-9 Assessment Fax completed log to: ATTN: CODIACS ID NUMBER: FORM CODE: PHQ VERSION:A 03/12/10 Administrative Information 0a. Completion Date: / / 0b. Staff ID: Month Day Year Instructions: This form is completed by the treatment specialist as part of the evaluation process. Affix the participant ID label above. Depression Symptoms (PHQ-9 Score, Administered by (check one) [ ] Self [ ] Interview) Over the last 2 weeks, how often has patient been bothered by Not at all (0) Several days (1) More than half the days (2) Nearly every day (3) 1. Little interest or pleasure in doing things [ ] [ ] [ ] [ ] 2. Feeling down, depressed, or hopeless [ ] [ ] [ ] [ ] 3. Trouble falling or staying asleep, or sleeping too much [ ] [ ] [ ] [ ] 4. Feeling tired or having little energy [ ] [ ] [ ] [ ] 5. Poor appetite or overeating [ ] [ ] [ ] [ ] 6. Feelings of guilt and/or failure [ ] [ ] [ ] [ ] 7. Trouble concentrating [ ] [ ] [ ] [ ] 8. Psychomotor retardation and/or agitation [ ] [ ] [ ] [ ] 9. Thoughts of death or suicide [ ] [ ] [ ] [ ] 1

43 Clinical Evaluation of Current Depression Fax completed form to: ATTN: CODIACS ID NUMBER: FORM CODE: CEC VERSION:A 02/01/10 Contact Occasion SEQ # Administrative Information 0a. Completion Date: / / 0b. Staff ID: Month Day Year Instructions: This form combines items from the PRIME-MD and the revised DISH. It will be administered to Stepped Care participants as needed and may be used as a tool to guide the intervention. A. Current Major or Minor Depressive Episode For the last 2 weeks, have you had any of the following problems nearly every day? # Symptom No Yes 1. Trouble falling or staying asleep, or sleeping too much? 2. Feeling tired or having little energy? 3. Poor appetite or overeating? 4. Little interest or pleasure in doing things? 5. Feeling down, depressed, or hopeless? a. 8b. 8c Feeling bad about yourself or that you are a failure or have let yourself or your family down? Trouble concentrating on things, such as reading the newspaper or watching television? Being so fidgety or restless that you were moving around a lot more than usual? If no to 8a: What about the opposite moving or speaking so slowly that other people could have noticed? Check Yes if Yes to either 8a or 8b, OR if psychomotor agitation or retardation is observed during the interview In the last 2 weeks, have you had thoughts that you would be better off dead, or of hurting yourself in some way? If Yes: Tell me about it. Conclusion a. Current Major Depressive Episode: Five or more symptoms, including #4 and/or #5. b. Current Minor Depressive Episode: Two to four symptoms, including #4 and/or #5. c. Does not meet criteria for major or minor depression. Clinical Evaluation of Current Depression Page 1 of 3

44 B. If the criteria for a current major or minor episode are met, ask: # Episode Duration and Onset 1. How long have you been feeling this way? (weeks) 2. Did this start before or after your recent heart attack? Before After C. If the criteria for a current minor episode are met, ask: # Major Depression in Partial Remission No Yes Lately, you ve been having just a few of the symptoms I asked you 1. about. When you first started feeling down, losing interest, etc., did you have any other symptoms? Ones that have gotten better since then? 2. Conclusion: Is this an episode of major depression in partial remission? D. History of Major Depressive Episodes # Prior Major Depressive Episodes No Yes 1. Was there ever a time in the past when you were very feeling down or depressed, or when you lost interest or pleasure in doing things, for at least a couple of weeks? 2. If yes to #1: At the same time(s), did you also have any of the other symptoms I was asking you about? 3. If yes to #1 and #2: How many times in your life have you been through this (that is, times when you felt down or depressed, or lost interest or pleasure in your usual activities, and you also had at least several other symptoms), for two weeks or longer? 4. If yes to #1 and #2: About how old were you the first time? 5. E. Dysthymia If yes to #1 and #2: How old were you the last time (not counting the current episode, if one is present). # Dysthymia No Yes Over the last 2 years, have you often felt down or depressed, or had 1. little interest or pleasure in doing things? Count as Yes only if also Yes to: Was that on more than half the days over the last 2 years? 2. In the last 2 years, has that often made it hard for you to do your work, take care of things at home, or get along with other people? 3. Conclusion: Is dysthymia present? (Requires both #1 and #2) Clinical Evaluation of Current Depression Page 2 of 3

45 F. Bipolar Disorders # Bipolar Disorders No Yes 1. Have you been through periods when you were feeling unusually energetic, over-confident, too active, too talkative, speeded up, etc.? 2. Has a doctor ever told you that you were manic depressive or that you had a bipolar disorder? If yes to #2: Have you ever been treated for this condition? 2a. Notes: 3. If a more detailed bipolar disorder assessment is needed, administer the Mood Disorder Questionnaire. G. Depression Treatment History # Depression Treatment History No Yes 1. Have you ever been treated for depression? 2. Have you ever taken an antidepressant? Antidepressant: 2a. Approximate dates: Did it help? Were there any side effects? Antidepressant: 2b. Approximate dates: Did it help? Were there any side effects? Antidepressant: 2c. Approximate dates: Did it help? Were there any side effects? Have you ever had counseling or psychotherapy for depression? 3. Notes: 4. Have you ever had any other kind of treatment for depression? Notes: Clinical Evaluation of Current Depression Page 3 of 3

46 8. TREATING INSOMNIA Educate patients that difficulties falling and staying asleep are not uncommon after ACS. Practice good sleep hygiene: follow a regular schedule, establish a bedtime routine, keep bedroom dark and quiet, use bedroom to sleep (not to eat, watch TV, etc.), exercise during the day (not in the evening), avoid naps. Minimize the long-term use of hypnotics, alcohol, or over-the counter sleep preparations. Avoid stimulants before bedtime: coffee, tea, sodas, chocolate, smoking Consider use of sedating antidepressants such as Mirtazapine, Nefazodone. Consider Trazodone ( mg po qhs) along with other antidepressants (watch for orthostatic hypotension at higher doses). Short term use of benzodiazepines. These drugs can cause cognitive impairment, drowsiness, accidents, and falls. Use short acting agents such as Oxazepam (10-30 mg po qhs), Zaleplon (10-mg po qhs), Zolpidem (5-10 mg po qhs) Consider use of behavioral treatments: progressive muscle relaxation, meditation Consider evaluation for sleep apnea if patients are obese or patient / spouse report loud snoring or frequent naps / falling asleep during the daytime.

47 APPENDIX D. How to Schedule a PST Session. All PST sessions will be scheduled using Google calendars. The centralized PST treatment specialist will manage their own calendars. Each site will be given a Google account and granted access to the PST calendars. How to Request Access Each recruitment site will need access to two Google calendars: 1. Vivian Medina: vmedina31@gmail.com 2. Ellen Dornelas: dornelaspst@gmail.com If you do not have access to these two calendars, please the PST treatment specialist directly to ask for permission to view and edit. How to Schedule an Initial PST Session 1. Open the Google calendar for your recruitment site 2. You should see a screen similar to this: 3. Each PST Treatment Specialist will have blocked off times which they are available to meet with participants. These are designated as CODIACS PST AVAILABLE SLOT. 4. Find the first AVAILABLE time when both the participant and one of the PST Treatment Specialists are free. Please note: if the participant is Spanish-speaking, the participant must be scheduled to meet with Vivian Medina. 5. Open that appointment by double-clicking.

48 6. Change the What line of appointment to SITE, ID#, Subject initials. Do not include any identifying participant information (such as name) in the appointment. For example:

49 7. Click Save 8. If an Edit recurring event window appears, select Only this instance

50 9. The appointment has been successfully added to the Treatment Specialist calendar. 10. As a final step, please the appropriate Treatment Specialist with the following information: a. Notification that the appointment was created; b. Participant name c. Participant contact information (include date of birth, home address, and cell, work and phone numbers) Please note that the preferred method to send this information is in a password-protected document. The password should be sent in a separate . How to Schedule Subsequent PST Sessions 1. Following the initial PST session, the PST Treatment Specialist will work with the participant to set future appointments. The PST Treatment Specialist will be responsible for updating her own calendar. 2. In the event that the participant chooses to continue with WebEx PST sessions, the PST Treatment Specialist will contact the unblinded coordinator at your site to book an exam room for the participant. Questions If you have any questions, please contact Liz Capone-Newton at eac126@columbia.edu or at

51 APPENDIX E: Tracking Forms 1. Psychiatric Evaluation 2. PST Initial Evaluation 3. PST Follow-up Contact 4. Log 5. Treatment Change Review 6. Relapse Prevention Plan Please visit the study website at for forms and manuals. The unblinded coordinator (UC) at your site can provide you with the appropriate username and password.

52 1. Psychiatric Evaluation Fax completed form to: ATTN: CODIACS ID NUMBER: Administrative Information 0a. Completion Date: / / 0b. Staff ID: Instructions: This form is completed every 1 to 2 weeks for participants randomized to Stepped Care + antidepressant medication. The form is completed by the staff psychiatrist at the field center. Type of contact (check one) [ ] In-person [ ] Telephone [ ] Webcam Reason(s) for evaluation: (Check all that apply or write in) [ ] Persistent depression [ ] Medication side effects [ ] Diagnostic evaluation/clarification [ ] Follow-up History: Write in: Current medications: NOTE: If the participant is on any of the following drugs, or starts taking these drugs, you must let the depression treatment specialist know right away. Isocarboxazid (Brand name Marplan) Phenelzine (Brand name Nardil) Tranylcypromine (Brand name Parnate) Selegeline (Brand name Emsam, a transdermal patch) Current Medical Problems:

53 Psychiatric diagnoses and symptoms (Check all that apply) [ ] * Major depression * [ ] PTSD [ ] Somatoform disorder [ ] * Dysthymia * [ ] Anxiety disorder NOS [ ] Alcohol / substance abuse [ ] Bipolar disorder [ ] Primary Psychotic disorder [ ] Family history of depression [ ] Other depressive disorder [ ] Dementia Other [ ] Panic disorder [ ] Delirium [ ] Obsessive compulsive disorder [ ] Other cognitive problem Potentially contributing medical disorders (Check all that apply) [ ] Hypothyroidism [ ] Parkinson s disease [ ] Chronic pain syndromes [ ] Hyperthyroidism [ ] Cerebrovascular disease [ ] Other neurologic disorders [ ] Hyperadrenocorticalism [ ] Sleep Apnea Other [ ] Hyperparathyroidism [ ] Cancer [ ] Hypoakalemia [ ] Congestive heart failure [ ] Hyponatremia [ ] B 12 or folate deficiency Potentially contributing medications / substances (Check all that apply) [ ] Steroids [ ] Narcotic analgesics [ ] Alcohol [ ] Beta blockers [ ] Benzodiazepines [ ] Stimulant withdrawal [ ] Antineoplastic agents [ ] Other sedatives Other Potentially contributing social stressors Coping strategies and support available

54 History: Data: Formulation

55 Treatment recommendations Medication: Name Dose (per day) Time of day Duration (no. of days) Comments Psychotherapy: [ ] PST_PC Other: Other treatment: [ ] ECT Referral: Suicide Ideation at this contact? [ ] Yes [ ] No (If yes, fill out Suicidality Form.) Unanticipated problem at this contact? [ ] Yes [ ] No (If yes, fill out Unanticipated Problem Report.) Comment & Recommended follow-up: Problem list discussed during this session (check all that apply): Problem with relationships: o Spouse or partner o Family members: children, grandchildren, other family members o Friends o Other: Problem with work or volunteer activities: Problems with money and finances: Problems with living arrangements: Problems with transportation: Problems with health: Problems with having a daily peasant activity: Problems with sexual activity: Problems with religion or moral values: Problems with self-image: Problems with aging: Problems with loneliness: Assessed by:

56 2. PST Initial Assessment Fax completed log to: ATTN: CODIACS ID NUMBER: 0a. Date of Contact: / / 0b. Staff ID: Type of contact (check one) [ ] In-person [ ] Telephone [ ] Webcam Contact duration: Other Symptoms [ ] Anxiety [ ] Pain [ ] Manic Symptoms [ ] Psychotic Symptoms [ ] Alcohol/Substance Abuse History: Mental Status: Current Medical Problems: Current Medications: List both prescription & non-prescription medications (check those that may contribute to depression) 1. [ ] 2. [ ] 3. [ ] 4. [ ] 5. [ ] 6. [ ] 7. [ ] 8. [ ] 9. [ ] 10. [ ] 11. [ ] 12. [ ] 13. [ ] 14. [ ] 15. [ ] 16. [ ] 17. [ ] 18. [ ]

57 Stressors: Strengths and Resources: Pleasant activities: Treatment History: Assessment:

58 Suicide Ideation at this contact? [ ] Yes [ ] No (If yes, fill out Suicidality Form.) Unanticipated problem at this contact? [ ] Yes [ ] No (If yes, fill out Unanticipated Problem Report.) Other Treatments: Other Comments: Next Followup with: Date & Time: Location: Problem list discussed during this session (check all that apply): Problem with relationships: o Spouse or partner o Family members: children, grandchildren, other family members o Friends o Other: Problem with work or volunteer activities: Problems with money and finances: Problems with living arrangements: Problems with transportation: Problems with health: Problems with having a daily peasant activity: Problems with sexual activity: Problems with religion or moral values: Problems with self-image: Problems with aging: Problems with loneliness:

59 3. PST Follow Up Contact Fax completed form to: ATTN: CODIACS ID NUMBER: 0a. Date of Contact: / / 0b. Staff ID: Type of contact (check one) [ ] In-person [ ] Telephone [ ] Webcam Contact duration: Subjective: Mental Status: Stressors, Strengths, and Resources:

60 Assessment: Suicide Ideation at this contact? [ ] Yes [ ] No (If yes, fill out Suicidality Form.) Unanticipated problem at this contact? [ ] Yes [ ] No (If yes, fill out Unanticipated Problem Report.) Other Treatments: Other Comments: Next Followup with: Date & Time: Location: Problem list discussed during this session (check all that apply): Problem with relationships: o Spouse or partner o Family members: children, grandchildren, other family members o Friends o Other: Problem with work or volunteer activities: Problems with money and finances: Problems with living arrangements: Problems with transportation: Problems with health: Problems with having a daily peasant activity: Problems with sexual activity: Problems with religion or moral values: Problems with self-image: Problems with aging: Problems with loneliness:

61 PHQ-9 History and Missed Appointments Log Fax completed log to: ATTN: CODIACS ID NUMBER: FORM CODE: PHL VERSION:A 03/12/10 0a. Completion Date: / / 0b. Staff ID: Instructions: This form is completed by the treatment specialist as part of the evaluation process. Affix the participant ID label above. Date PHQ9 Score Location (1) Office (2) Phone (3) Webcam SESSIONS Contact Duration (minutes) Suicidality Form Completed (No / Yes) Unanticipated Problem Reported (No / Yes) MISSED SESSIONS Date Reason (1) No show (2) Cancelled/not rescheduled (3) Rescheduled MEDICATION CHANGES Date Medication Dose Units PHQ9 History and Missed Appointments Log Page 1

62 Treatment Change Review Fax completed forms to: ATTN: CODIACS ID NUMBER: FORM CODE: TCR VERSION:A 3/08/10 Contact Occasion SEQ # 0a. Date of Review: / / 0b. Staff ID: Month Day Year 1. Purpose of today s review [select only one]: Step Two [@ 6-8 weeks in treatment] Step Three [@ weeks in treatment] Participant requests change outside Step Review Tx Specialist recommends change outside Step Review Step 2 Target Date: / / 20 mm dd yy Step 3 Target Date: / / 20 mm dd yy Treatment team present at review: CODIACS Treatment: Step 1: Initial Treatment 2. Participant choice of treatment... P=PST M=MED B=Both PST & MED 3. Tx Specialist recommendation of treatment... P=PST M=MED B=Both PST & MED 4. Treatment participant received... P=PST M=MED B=Both PST & MED Step 2: Step 2 Treatment 5. Has the participant completed Step 2?... No [skip to item 9] Yes 6. Participant choice of treatment at Step 2... P=PST M=MED B=Both PST & MED 7. Treatment team recommendation for Step 2... P=PST M=MED B=Both PST & MED 8. Treatment participant received at Step 2... P=PST M=MED B=Both PST & MED Current Treatment [prior to today s review] 9. What is the current treatment? P=PST M=MED B=Both PST & MED A=Maintenance 9a. If maintenance, when did phase begin? / / 2 0 Brief Patient History [prior to participation in study] Month Day Year Treatment Change Review Page 1 of 3

63 ID #: Summary of participant s progress in study treatment and/or reason for treatment change: Participant Requested Change in Treatment 10. Did the participant request a change in treatment?... No Yes Select only one option per row. Antidepressant Dose Units Continue Stop Add Decrease Increase PST N Y MED1 N Y MED2 N Y Other N Y Describe: Treatment Specialist s Recommended Change in Treatment Select only one option per row. Antidepressant Dose Units Continue Stop Add Decrease Increase PST N Y MED1 N Y MED2 N Y Other N Y Describe: Treatment Team s Recommendation Select only one option per row. Antidepressant Dose Units Continue Stop Add Decrease Increase PST N Y MED1 N Y MED2 N Y Other N Y Describe: Continue to next page after the treatment recommendation has been discussed with the participant. Treatment Change Review Page 2 of 3

64 PST Follow Up Contact Fax completed form to: ATTN: CODIACS ID NUMBER: 0a. Date of Contact: / / 0b. Staff ID: Type of contact (check one) [ ] In-person [ ] Telephone [ ] Webcam Contact duration: Subjective: Other Symptoms [ ] Anxiety [ ] Pain [ ] Manic Symptoms [ ] Psychotic Symptoms [ ] Alcohol/Substance Abuse Mental Status: Stressors, Strengths, and Resources: Assessment: 1

65 Suicide Ideation at this contact? [ ] Yes [ ] No (If yes, fill out Suicidality Form.) Unanticipated problem at this contact? [ ] Yes [ ] No (If yes, fill out Unanticipated Problem Report.) Other Treatments: Other Comments: Next Followup with: Date & Time: Location: Problem list discussed during this session (check all that apply): Problem with relationships: o Spouse or partner o Family members: children, grandchildren, other family members o Friends o Other: Problem with work or volunteer activities: Problems with money and finances: Problems with living arrangements: Problems with transportation: Problems with health: Problems with having a daily peasant activity: Problems with sexual activity: Problems with religion or moral values: Problems with self-image: Problems with aging: Problems with loneliness: 2

66 Relapse Prevention Plan Fax completed log to: ATTN: CODIACS ID NUMBER: 0a. Completion Date: / / 0b. Staff ID: Today s PHQ9 Score: 1. Review the course of symptoms up to now and address the following: distress and/or depression symptoms impact of the adjustment distress on the patient s ability to function at home and at work current treatment(s) and treatment(s) tried before questions about treatment(s) Notes: 2. Review risk factors for relapse. 2 or more prior episodes of depression dysthymia: chronic depressive symptoms for 2 years or more residual depressive symptoms (patient is not completely back to baseline) Remind the patient that these are risk factors for relapse of symptoms. We know from prior research that, without active treatment, 50% of patients with one prior episode of major depression will have a relapse within two years. Patients with 2 or 3 prior episodes have a 70 or 90% chance of relapse, respectively. 3. Review the rationale for continuing medication or maintenance PST and encourage the patient to do so. Research has shown that full doses of antidepressants (i.e., the doses which resulted in the initial remission of symptoms) or ongoing maintenance psychotherapy significantly reduce the risk of relapse. For some patients, medication maintenance treatment may be required indefinitely. Get a sense of what might motivate the patient to stay on long-term medication. Reinforce the patient s motivation to do so as much as possible. Notes: 4. Review any concerns about continuing medications or psychotherapy and anticipate potential barriers. Start out with neutral question such as I wonder how you feel about taking your antidepressant medication long term? Point out that up to 50 % of patients with chronic medical illnesses have difficulty taking their medications as prescribed. Ask patients to generate a list of pros and cons of staying on medication long term, and to weigh these against the risks and benefits of stopping antidepressants. Patients may have a number of concerns about the long-term use of antidepressants, and it is important to address these as much as possible. (See Section 5 (E), Commonly Asked Questions Regarding Antidepressants). Notes: Relapse Prevention Plan Page 1 of 2

67 5. Discuss early warning signs of distress. Patients and significant others can learn to recognize such early warning signs and get help before relapses become severe. Common early warning signs include changes in sleep, appetite, or energy level, loss of interest in usual activities, irritability or withdrawal from others. These early warning signs differ from patient to patient. Patients or significant others may remember early signs of distress from their most recent episode. In many cases, spouses or significant others may notice such warning signs before a patient does, and it can be very helpful to involve them in the monitoring for such signs. Notes: 6. Make a relapse prevention plan. It can be very discouraging to experience a recurrence of symptoms. If patients detect these symptoms early on, however, it may be easier to prevent a severe relapse. Encourage patients to think positively about seeking additional help for symptoms. Seeking such help should not be seen as a sign of failure, but as a positive step (i.e., I am doing something to take care of myself ). A relapse prevention plan for the patient includes early warning signs and a plan for what to do if you or a significant other notices such symptoms. Relapse Prevention Plan (check all that are discussed): discussing the situation with a close friend/relative making sure you are taking the medication as prescribed considering stressful life situations (problems at work, in one s family, etc.) which may lead to an exacerbation of symptoms and using the skills learned in PST to address them scheduling positive life events contacting the ADS contacting the cardiologic care provider or a psychotherapist who has been helpful in the past Note: 7. Discuss future clinic or telephone follow-up contacts. once per month date of 1 st maintenance call: 8. Remind patients that both you and the cardiologic care provider are available and how you can be reached. Note: Relapse Prevention Plan Page 2 of 2

68 APPENDIX F: NATIONAL AND LOCAL RESOURCES NATIONAL RESOURCES American Association of Retired Persons (AARP) 601 E St. NW Washington, DC Alcoholics Anonymous Alzheimer s Association National Office 225 North Michigan Ave., Suite 1700 Chicago, IL American Cancer Society ACS-2345 American Diabetes Association ATTN: National Call Center 1701 N. Beauregard Street Alexandria, VA DIABETES American Heart Association National Center 7272 Greenville Ave. Dallas, Texas Heart and Stroke Information: AHA-USA1 Women s Health Information: MY-HEART American Stroke Association Stroke Connection ARCH National Resource Center for Respite and Crisis Care Services 800 Eastowne Drive, Suite 105 Chapel Hill, NC X222 Depression and Bipolar Support Alliance (DBSA) 730 N. Franklin St., Suite 501 Chicago, IL Treatment Change Review Page 66 of 71

69 National Association for Continence P.O. Box 1019 Charleston, SC National Council on Aging 300 D Street, SW, Suite 801 Washington, D.C (website provides directory of Adult Day Services) National Diabetes Information Clearinghouse 1 Information Way Bethesda, MD (800) National Family Caregivers Association Connecticut Ave. #500 Kensington, MD (800) National Institute of Mental Health Office of Communications 6001 Executive Blvd., Room 8184, MSC 9663 Bethesda, MD OTHER AGING-RELATED WEBSITES Administration on Aging Alliance for Aging Research Alzheimer s Disease Education & Referral Center American Association for Geriatric Psychiatry American Geriatrics Society American Society on Aging Treatment Change Review Page 67 of 71

70 Eldercare Web Healthfinder for Older Adults Home Care Online Indiana University Center for Aging Research JAMA: Geriatrics Resources on the Net National Aging Information Center Administration on Aging National Institute on Aging The Resource Directory for Older People Self-Help for Hard of Hearing People Social Security Administration Online Treatment Change Review Page 68 of 71

71 LOCAL RESOURCES TRANSPORTATION: SENIOR CENTERS: OTHER Treatment Change Review Page 69 of 71

72 APPENDIX G. Schedule and Timing of Measures Treatment Change Review Page 70 of 71