Faculty. Delivering and Measuring the Outcomes of Cognitive Remediation across Clinical Settings. Evidence Base for Cognitive Remediation Therapy

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1 Faculty Delivering and Measuring the Outcomes of Cognitive Remediation across Clinical Settings Philip D. Harvey, PhD Leonard M. Miller Professor University of Miami Miller School of Medicine Miami, Florida Richard Keefe, PhD Professor of Psychiatry, Psychology and Neuroscience Duke University Medical Center CEO, NeuroCog Trials, Inc. Durham, North Carolina Raymond Kotwicki, MD, MPH Chief Medical Officer, Skyland Trail Adjunct Associate Professor Emory University School of Medicine Atlanta, Georgia Alice Medalia, PhD Clinical Director, Cognitive Health Services New York State Office of Mental Health Professor of Medical Psychology Columbia University Medical Center Columbia University College of Physicians and Surgeons New York, New York Part I: Cognitive Health to Promote Recovery Evidence Base for Cognitive Remediation Therapy Research Thriving as interest in neuroplasticity grows. Publications 270 Alice Medalia, PhD Clinical Director, Cognitive Health Services New York State Office of Mental Health Professor of Medical Psychology Columbia University Medical Center Columbia University College of Physicians and Surgeons New York, New York Let s Do Cognitive Remediation But what is it? Does it work for everyone? Is it covered by insurance? Who would do it? How do we implement it? Large Clinical Contexts Vary New York State Office of Mental Health 19,387 adults served annually in 62 clinics within 16 Adult Psychiatric Centers Small Columbia Psychiatry Lieber Recovery Clinic 230 persons served annually Outpatient service Private self pay Largest state mental health system; unique in geographic, cultural, and linguistic breadth

2 Context: The CRT Environment CRT requires specific conditions that affect its implementation in real-world settings. These requirements may differ from other evidence-based practices and thus require specialized agency conditions for implementation. With the Focus on Neuroplasticity Challenges Keeping sight of recovery principles We are treating the person not the brain CRT = cognitive remediation therapy. Implications for Cognitive Remediation Link CRT to Recovery Goals and pair it with the psychosocial treatments intended to facilitate goal attainment What is it you want to accomplish in the next months? Agree that CRT will help meet that goal Pair with other skills training How to organize = How to implement System Level Support for web connectivity and access to web-based cognitive exercises Staff training about cognition, CRT, and brief cognitive assessment Linking recovery models into CRT Reimbursement Agency Level Staffing Infrastructure Scheduling Leadership Access to training CENTRAL ADMINISTRATION Hire expertise Contract with vendors Manage budgets + administration + staffing LOCAL FACILITY CONTENT LEADER Staffing: a. for evaluation & screening b. for leading CRT group c. outcomes/qa Facility needs: space, set up, environment IT: computers and connectivity Train and supervise staff Work with administration Implement and support Train the Trainer EXAMPLE Staff, patients, and/or their support identify if patient has cognitive problems interfering with attainment of recovery goals If patient is interested in Tx refer for eligibility screening If eligible, patient has a cognitive assessment

3 CRT Research Informs CRT Implementation 36 years old (18 65) 12 years of education 17 weeks of treatment 32 hours N > 2700 Wykes T, et al. Am J Psychiatry. 2011;168(5): Kurtz MM, et al. Schizophr Bull. 2012;38(5): Mild-moderate symptoms In- and outpatients with psychosis 2 3 times a week ASSESSMENT EXAMPLE Eligible patients take a 50-minute neurocognitive assessment Testing done by trained clinician A neurocognitive report identifies strengths and weaknesses across specific cognitive domains Results inform a treatment plan Results shared with patient and treatment teams INTERVENTION EXAMPLE Shared decision-making to select a tailored CRT intervention Computer-based cognitive exercises tailored for the individual followed by group discussion Linking to personal recovery goals with ongoing feedback to team Research on Variables that Significantly Moderate Impact of CRT Cognitive Outcome Intensity Motivation Functional Outcome Treatment Context Strategy + Practice The CRT program consists of 2 one-hour sessions/week for 15 weeks Medalia A, et al. Neuropsychol Rev. 2009;19(3): Wykes T, et al. Am J Psychiatry. 2011;168(5): CRT from Start to Finish Implementation Requires Sustaining Entry Referrals: Staff know who to refer Assessment: Cognitive need as linked to recovery goals Treatment Computer Exercises Manuals Consistent participation Staff facilitation Integration with recovery plan Exit Assess progress toward treatment goals Recognize when treatment is not working Train the trainer methodology bolstered with updates from content leaders, conferences, learning collaboratives, and local champions Quality-based measurements for program are program-evaluation specific: Satisfaction Engagement + Adherence Recovery goals met Overall functionality (pre- / post-)

4 RESOURCES Lectures: CRT Manuals: Conference: Part II: Delivery of CRT in a Private Non-Profit Community Mental Health Setting Raymond Kotwicki, MD, MPH Chief Medical Officer, Skyland Trail Adjunct Associate Professor Emory University School of Medicine Atlanta, Georgia Non-Profit Community Health Setting Private non-profit residential, PHP, IOP, and outpatient services offered in Atlanta, GA CRT is a pillar of the Cognition and First Episode (CAFÉ) Recovery Track ADMISSION Measure cognition (BAC A) BAC A > 40 TREATMENT Usual Care Cognitive Training CAFÉ Track and/or BAC A 40 Healthy Challenge Both DISCHARGE Measure cognition (BAC A) CRT Delivery in Treatment Online program is self-directed by patient Employs adaptive testing across attention, brain speed, memory, people skills, intelligence, and navigation Tracks tasks completed and directs patient to other skill exercises offered Logs time spent on CRT exercises Group setting offered 4 per week for 45 minutes in a computer lab Group is monitored by Certified Peer Specialist or case manager and managed by a Master-level counselor BAC-A = Brief Assessment of Cognition in Affective Disorders. Adjunctive Therapies Offered Over 15 different services offered in group and individual setting to improve life, social, and vocational skills 318 patients have received an average of 13 services during treatment; 156 unique groups weekly Services offered include: Building Wellness Meditation (CBCT) Cooking for Your Health Encouraging Healthy Lifestyles Personal Training Seeking Healthy Relationships Interviewing Skills Return to School Return to Work Social & Assertiveness Skills Outcome Data 272 patients were assessed during the admission process from May 2016 to May % were referred to CRT based on CAFÉ recovery track and/or BAC-A 40 Patients on average trained 12 days and earned 270 stars during CRT 35 patients had pre- and post-treatment BAC-A scores for comparison and were included in the preliminary analyses (18 are currently still in treatment)

5 Demographic Data Gender is Equally Distributed Predominantly Young Adults (N = 35) (N = 35) Prevalence of Cognitive Impairments by Diagnosis 85% 79% 79% 49% 51% 71% 63% 59% 48% 52% 37% 41% 29% 21% 21% 15% female (N=17) male (N=18) 25 year old (N=25) >25 years old (N=10) Anxiety Bipolar Depression Schizophrenia, Other (includes Schizoaffective Personality, OCD, No Cognitive Impairment Cognitive Impairment PTSD) Total OCD = obsessive-compulsive disorder; PTSD = posttraumatic stress disorder. Psychiatric Rehabilitation: Prevalence of Impaired Cognition Across Diagnoses]. Unpublished raw Cognition Improvement (BAC-A) t (34) = , P = Females Mean BAC A Scores Improved by 1.7 over Males Older Adults Mean BAC A Scores Improved Twofold That of Young Adults female (N=17) male (N=18) mean change in BAC A 25 year old (N=25) >25 years old (N=10) mean change in BAC A Bipolar Patients Experience the Greatest Improvement in Mean BAC 7.1 A Score Pre Treatment BAC A Scores Post Treatment 0.0 Anxiety (N=0) Bipolar (N=11) Depression Schizophrenia Other (N=9) (N=13) (N=6) mean change in BAC A Psychiatric Rehabilitation: Prevalence of Impaired Cognition Across Diagnoses]. Unpublished raw Themes Improvement in cognition varied by: Gender: Females improved more than males Age: Older Adults improved more than Adults 25 years of age and younger Diagnosis: Patients with a primary diagnosis of Bipolar Affective Disorder experienced the greatest improvement BAC-A scores at admission show that patient population in this study is not as cognitively impaired as in the general population used to create norms for the assessment Lessons Learned and Extension of CRT Program Motivation to participate in CRT during treatment day is low and considered boring when delivered in computer lab setting Maximize social engagement while patients participate in CRT via use of the training apps for smart phones and tablets Patients that also participated in the Healthy Challenge physical exercise group (N = 12) improved their BAC-A scores by 5.75 t(11) = , P =.049 Patients that participated in CRT tend to show improved graduation rates

6 Methods of Assessing Cognition in the Clinic Part III: Assessment of Cognitive and Functional Change Richard Keefe, PhD Professor of Psychiatry, Psychology and Neuroscience Duke University Medical Center CEO, NeuroCog Trials, Inc. Durham, North Carolina 1. Comprehensive cognition batteries 2. Brief or very brief cognition tests 3. Functional capacity measures 4. Community outcome measures 5. Patient/caregiver/staff assessment No Consensus on Assessment for Measuring Cognitive Change in the Clinic Brief (15-30 m) Performanced-Based Measure of Functional Capacity Briefer (< 10 min) Interview Based Measure of Cognition Very Brief (< 5 min) Schizophrenia Cognition Rating Scale (SCoRS) 20 anchored items rated 1 (none) to 4 (severe) Assesses all 7 MATRICS cognitive domains Memory: 4 items Learning: 2 items Attention: 3 items Working memory: 2 items Problem solving: 3 items Processing/motor speed: 2 items Social cognition: 3 items Language: 1 item Self-Administered Based upon the responses of 23 Key Opinion Leaders in schizophrenia research and treatment Keefe RS, et al. Schizophr Bull. 2016;42(1): SCoRS Pros and Cons BAC/BACS Cognitive Domains Good test-retest reliability (ICC =.80) Small practice effects Small to medium placebo effects Correlated with cognition Correlated with real-world functioning Sensitive to treatment Requires informant in patients with schizophrenia

7 Benefits of Computer-Assisted Testing The best of both worlds Voice-overs for standardized instructions and intonation Standardized presentation rates and inter-stimulus intervals Automated stimulus selection/ alternate forms for counterbalancing Automated response capture, audio capture, scoring (where applicable), and data transfer Rater scoring of items that require judgment (eg, semantic content) Interaction between rater and participant: to confirm understanding, provide generalized positive feedback/ encouragement Qualitative insight to the testing session factors that may have affected performance or test validity Audio capture of participant s responses permits independent quality checks Sensitivity of the BAC App to Cognitive Impairment in the Schizophrenia Group Verbal Memory Token Motor Digit Sequencing Atkins AS, et al. Schizophr Res. 2017;181: Verbal Fluency Symbol Coding Tower of London Composite Score (not modified) BAC App Validation Study Results BAC App demonstrated equivalent sensitivity to cognitive deficits in schizophrenia Cohen s d = 1.34 for the BAC App, d = 1.25 for the pen-and-paper BAC Atkins AS, et al. Schizophr Res. 2017;181: BAC App Composite Scores (T scores) Correlation between Modalities: Modified Composite Modified* Composite T scores Paper BAC Composite Scores (T scores) Controls (r=0.88) Patients (r=0.89). * Modified composite scores incorporated a 10-point adjustment to the BAC App Symbol Coding raw score prior to standardization, and elimination of the Token Motor test from composite calculations for both the BAC App and Paper BAC. Atkins AS, et al. Schizophr Res. 2017;181: Validation in Schizophrenia VRFCAT is sensitive to deficits in schizophrenia Correlates with cognitive performance (r =.58 with MCCB) Good test-retest reliability (ICC =.81), minimal practice effects Part IV: Skills Training as an Adjunct to Cognitive Remediation Philip D. Harvey, PhD Leonard M. Miller Professor University of Miami Miller School of Medicine Miami, Florida *Significant differences between HC and SZ at the 0.05 significance level. HC = healthy control; SZ = schizophrenia; MCCB = MATRICS Consensus Cognitive Battery; VRFCAT = Virtual Reality Functional Capacity Assessment Tool. Keefe RS, et al. Schizophr Res. 2016;175(1-3):90-96.

8 Meta-Analysis of Functional Benefits of Cognitive Remediation Large-scale Meta-analysis Several critical findings for cognition and functioning Strategic > Repetition Better with Psychosocial Intervention No symptom effects Does Improving Cognition Have an Impact on Functioning? Wykes T, et al. Am J Psychiatry. 2011;168(5): Fisher M, et al. Schizophr Bull. 2015;41(1): Different Goals of Skills Training Get a job, any job Live independently Return to previous level of functioning Return to school Increase social network size Different Training Strategies Individualized placement and support (IPS) Available at every VA hospital in the United States Functional Adaptation Skills Training (FAST) 26-hour comprehensive training program Multiple additional programs Combined CRT and Skills Training Outcomes of the Study: End of Treatment Effect Size (Cohen s d) COG REM FAST Both NP UPSA SLOF Bowie CR, et al. Am J Psychiatry. 2012;169(7): FAST = functional adaptation skills training; UPSA = University of California San Diego Performance- Based Skills Assessment Battery. Bowie CR, et al. Am J Psychiatry. 2012;169(7):

9 UCLA Study of Cognitive Remediation after a First Psychotic Episode 12-month randomized controlled trial with first-episode schizophrenia patients at the UCLA Aftercare Research Program Patients received Individual Placement and Support to provide a context of active work rehabilitation Randomly assigned to cognitive remediation or healthy behavior training after stabilization Randomized to long-acting medications or oral antipsychotics So, everyone gets skills training with a double randomization McGurk SR, et al. Am J Psychiatry. 2015;172(9): Nuechterlein KH, et al. Presented at: 14th International Congress on Schizophrenia Research; April 21-25; Grande Lakes, FL. Cognitive Training Leads to Better Work/School Role Functioning in 12 Months of Treatment Change in Work/School Functioning Cognitive Training Healthy Behavior Trng N = 53. Group X Time interaction, P =.03. Nuechterlein KH, et al. Presented at: 14th International Congress on Schizophrenia Research; April 21-25; Grande Lakes, FL. Conclusions CRT requires skills training for functional gains Gains can be wide ranging and are related to the training programs received Life goals need to be matched to the training CRT may be beneficial for a variety of patients with diverse diagnoses; however, it is ideally combined with additional adjunctive therapies to maximize real-world improvements Cognitive assessment tools need to be tailored to specific populations and practice sites Cognitive sequelae of untreated mental illnesses must be addressed and treated along with other symptoms and disabilities!