KAISER PERMANENTE OF COLORADO CONSENT TO PARTICIPATE IN A MEDICAL RESEARCH STUDY

Transcription

1 KAISER PERMANENTE OF COLORADO CONSENT TO PARTICIPATE IN A MEDICAL RESEARCH STUDY STUDY TITLE: Strategies for Overcoming Depression Symptoms Study (SOAR) PRINCIPAL INVESTIGATOR: Arne Beck You are being invited to participate in a research study being conducted by researchers from Kaiser Permanente of Colorado and the University of Colorado Boulder, in partnership with the University of Toronto Scarborough. To decide whether or not you want to be part of this research, you should understand the risks and benefits in order to make an informed decision. You have the right to know what the purpose of the study is, how participants are selected, what will happen, what the potential risks and benefits are and what is expected of you as a study participant. You also have the right to know how your personal health information may be used or given to others during the study and after it is finished. This process is called informed consent. This consent form gives information about the research study, which we will discuss with you. There may be words or phrases that you do not understand. Please ask us to explain anything you do not clearly understand. You may download a PDF copy of this consent form to think about or to discuss with family or friends before making your decision. When you feel that you understand the study and if you choose to take part in it, we will ask you to electronically click on I agree. The word we means the study doctors/researchers and other study staff. Who is sponsoring this study? The research costs of this study are being funded by the National Institute of Mental Health. What is this study about? This study examines whether using an internet program called Mindful Mood Balance to deliver Mindfulness Based Cognitive Therapy (MBCT) is effective for reducing residual depressive symptoms and preventing depressive relapse. 1.) Reducing residual depressive symptoms: Up to a third of people who have a history of major depression experience residual depressive symptoms. These symptoms are similar to those experienced during a depression episode but milder and can include: sleeping problems, feeling down or having trouble with motivation towards your daily activities, problems with concentration, and over or under eating. 2.) Preventing depressive relapse: Depression can often be a recurrent disorder that returns to people s lives even after they have recovered. There is good MMB Randomized Trial Page 1 of 14

2 evidence to suggest that learning psychological skills that address some of the thinking changes brought on by sad moods, can be helpful in preventing the return of symptoms. MBCT is one such treatment. Currently, MBCT involves attendance at 8 weekly in-person group sessions that are led by a therapist. A disadvantage of in-person MBCT is that because there are not enough therapists trained to deliver the intervention, access to this treatment is very limited. One solution to this problem could be to provide MBCT via the internet through the Mindful Mood Balance program so that patients without access to live, in-person groups can still be treated. An important question to answer, therefore, is whether this treatment is effective when it is provided via the internet. The Mindful Mood Balance program and website are designed to provide instruction in the identical skills and exercises that patients attending the in-person groups would receive. Research shows that MBCT is effective in reducing residual depressive symptoms and preventing relapse when it is delivered in person. However, MBCT delivered via the internet has not been studied as a treatment for the same problems and that is why we are conducting this study. What is the purpose of this study? The purpose of this study is to determine if use of an online MBCT program, called Mindful Mood Balance, helps to reduce residual depressive symptoms and prevent depressive relapse. Why are you asking me to take part in this study? We are asking Kaiser Permanente members who have a history of depression, are over 18 years of age, have not participated in previous studies with the Mindful Mood Balance program, have access to in the internet, and currently are experiencing residual depressive symptoms to participate in this study. How many people will be in this study? For this study, we anticipate 460 total participants at Kaiser Permanente Colorado (KPCO). If I agree to participate, how long will I be in this study? Your participation begins with your electronic signature on this consent and continues for 15 months. What will happen in this study? If you agree to take part in this study and sign this consent form, this is what will happen: MMB Randomized Trial Page 2 of 14

3 A study team member will speak with you on the phone and review the study, including a description of study procedures, potential risks, and alternative treatment options. You will be asked to electronically sign your consent by clicking I agree on this webpage. You will be asked to complete a screening visit and monthly online surveys for 14 months. Additionally, those who are randomly assigned to the Mindful Mood Balance group, will complete 8 weekly online sessions and at least 4 phone coaching sessions. Those randomly assigned to the usual care group will be provided with a list of resources available through Kaiser Permanente for depression care. Screening: If you agree to participate, you will be asked to take part in a phone screening process. This phone screening should take about 30 minutes. The screening will consist of questions about your history of depression treatment and any current depression symptoms. Not all individuals who electronically sign the consent and go through the screening process will be eligible to participate in this study. Random assignment: After screening, you will then be randomly assigned (by chance, like flipping a coin) to one of two study groups: Mindful Mood Balance online program or usual care that includes periodic assessments to monitor depression. You will have an equal chance of being assigned to either group. The table below shows what will happen in both group. MMB Randomized Trial Page 3 of 14

4 Mindful Mood Balance After screening, you will be asked to complete online questionnaires on your home computer designed to measure attention, cognitive processing, and memory. These will take minutes to complete. Monthly assessments of depression symptoms completed online (5 minutes to complete). If we detect worsening depression, we will intervene by calling you and helping connect you with appropriate behavioral health resources. We will provide you with a list of multiple resources that Kaiser Permanente offers for depression care. You are free to access them on your own or decide not to pursue any of these resources. At the end of the study we will ask you about what resources you used, if any. Mindful Mood Balance online program: The program will require 8 weekly hour web sessions completed on your own time, plus you will be asked to try to complete daily meditation skills between sessions. At the end of the study, you will be asked to complete online questionnaires similar to the one you did at the beginning of the study. Telephone coaching will be provided to assist with learning new mindfulness skills and with negotiating barriers to daily home practice. Option to opt in to weekly or daily automated reminder calls, texts, or s at a time/day of your choosing. Usual Care After screening, you will be asked to complete online questionnaires on your home computer designed to measure attention, cognitive processing, and memory. These will take minutes to complete. Monthly assessments of depression symptoms completed online (5 minutes to complete). If we detect worsening depression, we will intervene by calling you and helping connect you with appropriate behavioral health resources. We will provide you with a list of multiple resources that Kaiser Permanente offers for depression care. You are free to access them on your own or decide not to pursue any of these resources. At the end of the study we will ask you about what resources you used, if any. At the end of the study, you will be asked to complete online questionnaires similar to the one you did at the beginning of the study. If you are interested, you can access the MMB program once your participation in the study has ended. MMB Randomized Trial Page 4 of 14

5 Mindful Mood Balance Program: The emphasis in this program is on learning how to use mindfulness meditation to build skills for detecting and responding to mild sad moods so that they do not fuel depressive thinking patterns. A number of topics relevant to monitoring mood shifts, examining thinking styles and taking effective action when sad moods are present will be practiced and reviewed during each web session. Automated reminders, telephone coaching, and interactive web-based community (Mindful Mood Balance group only): Because learning new skills for working with your emotions, both pleasant and unpleasant can be challenging, we have put a number of supports in place to help you. The first of these is to offer you a minimum of 4 weekly telephone coaching sessions, with an option to expand to 8 telephone coaching sessions over the 8-week course. Additionally, you can choose to opt in to receiving automated call, text, or reminders to at a frequency (daily, weekly, monthly) and time of day of your choosing. These reminders can be for 1.) completing online sessions 2.) completing home practice or 3.) completing assessments. If we notice that you have not logged onto the online program for 2 weeks or you miss a monthly depression assessment, we will send you an or live phone reminder. Monitoring symptoms: If the online questionnaires indicate that you are experiencing high levels of depression or suicidal symptoms, we will outreach you immediately to talk with you further about these symptoms. During this call, we can assist you with scheduling appointments with behavioral health care providers at Kaiser Permanente. If you indicate you have a high level of suicidality, we want to ensure your safety and additionally are required by law to contact your health care providers and our crisis team at Kaiser Permanente. If the online questionnaire indicates that you are experiencing thoughts of selfharm you will receive an automatic notice stating: "You indicated that you may be having thoughts of harming yourself. We are concerned about you and want to be sure you get the help you need. If this is a life-threatening situation, please contact 911 immediately. Because we may not receive your survey response immediately upon your completing it, we encourage you to contact 24-hour clinical staff at Kaiser Permanente at ; they can help you 24/7 to access the support you may need. A member of our research team will follow up with you. If we receive your survey response between 8am and 8pm, we will contact you in the shortest time possible to talk to you further about how you are feeling and how we may best support you. If we receive your survey response between 8pm and 8am, we will contact you within the next hour 24-hour period. If we do not reach you after a number of attempts in this 24-hour period, we will contact the clinical staff at Kaiser Permanente and ask them to follow up with you. When we get in touch with you, we will ask you to provide your location and then complete a clinical assessment. In order for us to be able to contact you most MMB Randomized Trial Page 5 of 14

6 efficiently, we will ask, at the time of your first assessment, to provide us with the location where you anticipate completing the online surveys and we will update this information on a quarterly basis. What are the possible risks and discomforts of being in this study? There are no anticipated physical risks to you to this study, and your health care team at Kaiser Permanente will continue to provide your depression care regardless of your participation in this study. Those in the Mindful Mood Balance Group will be asked to complete stretching and yoga practices. Please do not do any practices that you think will be harmful to their health or well-being. It is possible that questions asked on the online assessments or during screening interview could make you feel uncomfortable. You are free to not answer any questions they do not wish to answer on the questionnaires and during interviews. Exploring depression may touch on sensitive and personal areas that may cause psychological discomfort or pain. Because this study deals with people with depression, every precaution will be taken to identify individuals at high risk of suicide. You will be given information about how to access help on a 24-hour, seven day a week basis, and your healthcare team will maintain close contact with you. The Mindful Mood Balance website will have a link to information on directly accessing behavioral health services. Anytime information is collected, there is a potential risk for loss of confidentiality. While this is a possible risk for this study, we will take careful, appropriate precautions to make sure that your information is not shared with anyone else. Your name and anything else that could identify you will be removed and replaced with a study identification number. will be used as the main form of communication in this study. While every effort will be made to ensure secure communications, absolute security of cannot be guaranteed. It is possible that the Mindful Mood Balance program may not be effective for an individual participant, and it is also possible that your depression could worsen while you are on this study. We have outlined a careful and specific plan for proactive monitoring and responding to the outcomes of each participant in an ongoing fashion during their participation in the study. Please discuss with your clinician or a member of the study team if you feel your depression is worsening. Risks related to Information storage Kaiser Permanente does not own or control NogginLabs or RedCap, companies who host the Mindful Mood Balance study website and study assessments.. MMB Randomized Trial Page 6 of 14

7 Although NogginLabs has undertaken measures to ensure data security and quality on the Mindful Mood Balance website, some potential risks some risks could still exist. These risks could include: Mindful Mood Balance may not work properly or be available for you to use at all ties. As soon as a problem is discovered, Kaiser Permanente will attempt to find and implement suitable measures to resolve the situation. All information about your use of the website will be stored at NogginLabs. Drs. Segal and Dimidjian are on the advisory board of Mindful Noggins, which is part of NogginLabs, a private company specializing in customized web based learning. Similarly, Kaiser Permanente does not own or control RedCap. All of your survey responses will be stored on a database at RedCap connected to your study ID. Qualtrics has a privacy policy in place that forbids any use or trading of information collected in surveys. The only identifiable information you will be asked on the survey is your study id. They will be storing data collected from the study surveys until we obtain the data and remove it from their files. However, because the company is not owned by Kaiser Permanente, there could be additional risks associated with breach of confidentiality. You will also be asked to provide an address to communicate with the Mindful Mood Balance website and to receive the website updates. The address you provide will not be owned or operated by Kaiser Permanente and will, therefore, not be protected under the Kaiser firewall. We also recognize that depression is a sensitive topic for many people. There is a risk that comments posted by other users on the website may make you uncomfortable. You will not be required to post any information or comments on the page, this should only be done to your level of comfort. The study may include risks that are unknown at this time. Will I be informed of new information? During the course of the study, you will be informed of any important new findings (either good or bad) such as changes in the risks or benefits resulting from participation in the research or new alternatives that might change your mind about your continued participation in the study. You may be asked to sign a new consent form if additional risks are found. Are there any benefits to being in this study? We cannot predict whether or not you will receive any direct benefit from being in this study. However, we hope that this study may help you and other patients in the future. MMB Randomized Trial Page 7 of 14

8 More generally, the information obtained from your participation in this study may help in the development of new therapies to treat residual depressive symptoms and prevent relapse following recovery and benefit others looking to help themselves in this way What are my choices if I do not want to be in this study? You may choose not to participate in this study. You may seek treatment through the Kaiser Permanente system even if you decide not to participate in this study, and your decision not to participate in the study will have no impact on your medical or mental health care. If you choose not to participate in this study, your alternatives include seeking prevention focused behavioral health care through the behavioral health department or through resources available on kp.org. You can talk about other approaches with your health care provider. We encourage you to make sure that you understand all of your choices before you decide to take part in the study. May I continue with my current depression treatment? Yes. This study is not intended to replace any ongoing mental health care therapy or medications you may already be receiving. This study will also not interfere with any treatment or medications you may be receiving. Will it cost anything to be in this study? There is no financial cost to you to take part in this study. All study sessions will be provided free of charge. No other aspects of your health care, whether for depression or other mental health conditions, will be provided as part of the study, and you will be expected to pay your usual co-payment for your visits to any KPCO providers. For members of KFHPC, your standard medical care will continue to be provided to you pursuant to the terms of your plan benefits described in your applicable KFHPC Evidence of Coverage, which may include co-payments, coinsurance, and deductibles. Will I be paid to be in this study? You will receive a $5, 10 or $20 Amazon.com gift cards after each assessment point. The maximum amount you could earn for completing every assessment point is $135. You will not receive gift cards if you miss a monthly assessment point, but will be eligible for future assessments. What if I am injured as a result of being in this study? MMB Randomized Trial Page 8 of 14

9 This study involves participation in a web-based psychotherapeutic program and completion of several web-based questionnaires, and does not involve the use of any drugs, devices, or procedures. Therefore, we do not expect that you would experience any injury. However, any injury or condition experienced by a member of Kaiser Foundation Health Plan of Colorado, Inc. (KFHPC), as a result of being in this study, will be treated and covered as described in your Health Plan Evidence of Coverage. No free medical care or other form of compensation will be offered by Kaiser Foundation Health Plan of Colorado, Inc., Kaiser Foundation Hospitals, The Colorado Permanente Medical Group, Inc., or the Kaiser Permanente staff conducting the study. Your consent to participate in this research study does not take away any legal rights which you may have in the case of negligence or legal fault of anyone who is involved with this study. Am I required to be in this study? Your participation in this study is completely voluntary. You are free to refuse to participate in this study. Your decision will not affect your medical care. If you decide to be in this study, you can change your mind at any time without any effect on your medical care or eligibility for future care or membership in KFHPC. Will my information be kept confidential? We will try to keep information about you as confidential as possible. Study information about you will be identified only by a unique study code. Personally identifiable information such as your name or medical record number will not be attached to your study data. The recordings and study data will have a study code number and the other researchers would not know your name or your Kaiser number. Your research records will be identified only by this unique study number. Researchers will ensure that the link between your name and these study numbers will never be released outside the study team. By signing this consent form, you will also be giving consent for the study investigator or his assistants to review your medical records as may be necessary for this study. Your identity will not be revealed in any publication or release of study results. Representatives from the various organizations may need to look at and/or copy your medical records and study records to make sure that the information is correct and to evaluate the conduct of the study. Additional information about the uses and disclosures of your Protected Health Information are described in the following section titled Authorization to Use and Disclose Protected Health Information. These include the following: the Department of Health and Human Services (DHHS); or MMB Randomized Trial Page 9 of 14

10 other regulatory agencies involved in keeping research safe for people also have a legal right to review this study; Kaiser Permanente Colorado Institutional Review Board (IRB a formal group of people that reviews research to protect the rights and welfare of participants) Representatives of Kaiser Permanente; and for medical necessity or to prevent serious harm to you or others, such as in cases of child abuse, domestic violence, or if you are suicidal. To the extent permitted by law and by signing this consent form, you allow access for the above representatives to inspect your research and clinical records without removal of identifying information, such as your name, initials, date of birth, sex, and race, to make sure that the information is correct and to evaluate the conduct of the study. Because of the need to release information to these parties, we cannot guarantee absolute confidentiality. State and federal law require KPCO to maintain privacy and security of your information. In this study, your information is going outside KPCO to a research organization or individual located outside the United States. Once your information is sent outside KPCO for the study, KPCO cannot guarantee the privacy and security of the information. The HIPAA Privacy and Security Rules may not apply. KPCO does require these researchers to protect the privacy and security of your information. Authorization to Use and Disclose Protected Health Information Why is this authorization required? The Privacy Rule is a federal law designed to safeguard your Protected Health Information (PHI). Your PHI is individually identifiable information about you, including your physical or mental health, the receipt of health care, or payment for that care. The Privacy Rule requires that researchers obtain your authorization to participate in this study. By signing this consent, you will permit Kaiser Permanente of Colorado (KPCO) researchers to use and disclose your PHI for the purpose of this research study. Your PHI will only be used and disclosed as described in this authorization, except as otherwise required by law. In order to participate in this research study, you must agree to the uses and disclosures of your PHI as described in this authorization. If you do not participate in the study, this also means that you will not have access to the intervention program through the study. Who will use or disclose my PHI? MMB Randomized Trial Page 10 of 14

11 KPCO researchers and the research team will use your PHI for the purposes of this study. The KPCO research team may also disclose your PHI to others outside of Kaiser Permanente. Your PHI may be viewed by or sent to the following: the Department of Health and Human Services (DHHS) or other regulatory agencies involved in keeping research safe for people; the Kaiser Permanente of Colorado Institutional Review Board (KPCO IRB) and/or the Colorado Multiple Institutional Review Board (COMIRB) (IRB a formal group of people that review research to protect the rights and welfare of participants); other representative of KPCO; Dr. Sona Dimidjian and select members of the University of Colorado at Boulder study team; Dr. Zindel Segal and select members of the University of Toronto study team; Dr. Robert Gallop from West Chester University for data analysis only; Qualtrics and Noggin Labs, the companies managing the Mindful Mood Balance website and assessments. Your PHI may also be sent to persons assisting with this study or to others as required by law. What is the purpose of the use or disclosure of my PHI? KPCO researchers will use your PHI, including your responses to interviews and questionnaires, to conduct the study, monitor your level of depression, measure the effect of the web-based program and determine research results, and for medical necessity or to prevent serious harm to you or others, such as in cases of child abuse, domestic violence, or if you are suicidal. Information from your research record used and disclosed for the study may include, for example, scores on instruments that measure levels of depression, your responses to questionnaires and interviews, and research observations relating to your participation in the study. Researchers at KPCO may use extracts of electronic mental health records to confirm your history of depression. For those randomized to the receive Mindful Mood Balance program, Noggin Labs will receive your name, and phone number to be used for reminder messages. This authorization to use and disclose your PHI will expire on August 30, Can I withdraw this authorization? Yes, at any time during this study you may decide that you no longer want to have your PHI used or disclosed as part of this study. If so, you must write a letter stating that you withdraw your authorization and send it to: Dr. Arne Beck, Principal Investigator, SOAR Study C/O: KPCO IRB PO Box Denver, CO If you withdraw your authorization, you will be required to end your participation in the study. KPCO researchers and the study sponsor, National Institute of Mental Health, may continue to use your PHI that was obtained before you withdrew your authorization. MMB Randomized Trial Page 11 of 14

12 KPCO researchers will not disclose your PHI after they receive your written request except as required by law. For example, even if you withdraw your authorization, KPCO researchers may be required by law to record and report anything that relates to your safety or the safety of others. What will happen to my PHI after it is disclosed? The KPCO research team will use and disclose your PHI only as described in this authorization. However, if someone receives your PHI from KPCO and then discloses it again to someone else, it may no longer be protected by the Privacy Rule. Can I see the information collected about me in this study? You may not be allowed to review the information collected about you for this research until the study is over. Will anything about this study go in my medical record? Once you have signed this consent the following statement will be entered into your medical record: Participating in Strategies for Overcoming Depressive Symptoms study. If you have questions, please contact the Principal Investigator, Dr. Arne Beck at or arne.beck@kp.org. When your involvement with the study ends, the following will be entered into your medical record: Participation in the Strategies for Overcoming Depressive Symptoms study terminated as of (mm/dd/yyyy). Your electronic signature on this consent form permits Drs. Dimidjian and/or Beck to communicate with your health care providers in the event you need more care than this study may offer. Should you become depressed and require referral to Behavioral Health or the crisis team for care beyond the scope of this study, the study staff will indicate in your medical record that you have received a referral. Your Mindful Mood Balance sessions and online questionnaire results will NOT be entered into your medical record. Will I get a copy of this consent form? Yes, we will you a copy of the consent form after you are enrolled in the study. What if I have questions or problems? During the study, you can contact members of the study team via at SOAR@kp.org. Any study-related questions, problems or injuries should be directed to the study investigator responsible for the study within Kaiser Permanente, Dr. Arne Beck at (303) MMB Randomized Trial Page 12 of 14

13 Questions about your rights as a study participant, comments or complaints about the study also may be presented to the Institutional Review Board for the Protection of Human Subjects, Kaiser Permanente of Colorado Institutional Review Board, P.O. Box , Denver, CO , telephone 303/ By clicking agree I have read the above and am satisfied with my understanding of the study, its possible benefits, risks, and alternatives. My questions about the study have been answered. I hereby voluntarily consent to participate in the research study as described. I will be given a copy of this consent form, which includes the Authorization To Use and Disclose Protected Health Information and of the attached "Research Participants Bill of Rights." I have read the above and am satisfied with my understanding of the study, it is possible benefits, risks, and alternatives. My questions about the study have been answered. I hereby voluntarily consent to participation in the medical research study as described. I have been offered copies of this consent form and of the Research Participants Bill of Rights. The authorization to use and disclose my PHI has been explained to me, and all of my questions have been answered. By electronically clicking I agree, I am giving my permission to allow the use and disclosure of my PHI for the research study as described above. MMB Randomized Trial Page 13 of 14

14 Kaiser Permanente Medical Care Program Research Participants Bill of Rights The following rights and privileges are guaranteed to all participants in medical research conducted within the Kaiser Permanente Medical Care Program. If you have questions about these rights, please call the Institutional Review Board at Please note that items 5 and 6 below apply to clinical trials and may not apply to the research in which you are participating. If you participate in medical research, you are entitled to certain rights that include but are not limited to the right to be: 1. Informed of the nature and purpose of the research. 2. Given an explanation of the procedures to be followed in the research and a description of any drug or device to be used. 3. Informed of any related discomforts and risks that can reasonably be expected from participation in the research. 4. Told of any benefits that can reasonably be expected from participation in the research. 5. Informed of any appropriate alternative procedures, drugs, or devices that might be advantageous to you and the relative risks and benefits of these alternatives. 6. If complications arise, informed of the availability of medical treatment, if any, after the medical research. 7. Given an opportunity to ask any questions concerning the research or about the procedures involved. 8. Told that you can decide to withdraw your consent to participate at any time with no effect on your health care benefits or medical care provided by Kaiser Permanente. 9. Given a copy of the signed and dated written consent form. 10. Allowed to decide for yourself whether to participate in research without any force, fraud, deceit, duress, coercion, or undue influence by anyone MMB Randomized Trial Page 14 of 14 KPCO IRB Approval Date IRB NUMBER: CO IRB APPROVAL DATE: 11/9/2015