Optimizing Cognitive Remediation
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|ClinicalTrials.gov Identifier: NCT04395157|
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Veterans with mental illness face challenges with community reintegration, including achieving vocational success, attaining their educational goals and going back to school, and maintaining a high quality of life. VA Mental Health Residential Rehabilitation Treatment Programs and Psychosocial Rehabilitation and Recovery Centers are designed to help Veterans overcome these barriers, but cognitive impairment often seen in Veterans with mental illness limits gains from these settings. Cognitive remediation interventions can be helpful, but they are either "one-size fits all," and thus may not be useful for all Veterans with mental illness, or are too narrow in scope, focusing on specific mental illnesses, limiting generalizability.
This project will test whether an objective neurophysiological biomarker, mismatch negativity (MMN), can better match the "right" Veteran to the "right" cognitive remediation treatment regardless of their specific mental health diagnosis.
|Condition or disease|
|Schizophrenia Stress Disorders, Post-Traumatic|
This is an observational, non-interventional study. Veterans within 4 weeks of starting services in VA Mental Health Residential Rehabilitation Treatment Programs (RRTP) and Psychosocial Rehabilitation and Recovery Centers (PRRC) will be recruited. Veterans with PTSD and psychosis-spectrum illnesses engaged in RRTPs and PRRCs will have their cognitive functioning assessed. Following this, mismatch negativity (MMN) will be assessed via electroencephalography (EEG). Participants will undergo a 1 hour computerized cognitive training program. They will be interviewed about their attitudes about EEG and computerized cognitive training. They will be followed monthly for a total of 4 months from study entry to assess recovery trajectory. This study aims to enroll 104 Veterans from the VA San Diego Healthcare System.
The Specific Aims of this proposal are 1) Determine whether MMN is related to functioning, psychosocial recovery and treatment engagement in VA rehabilitation milieus; 2) Determine whether MMN is linked to cognition and predicts cognitive remediation exercise performance in a heterogenous group of Veterans with mental illness. The proposal will also assess feasibility and acceptability of using biomarker-guided cognitive rehabilitation interventions in VA rehabilitation settings.
Information gained from this study will help establish a precision-medicine approach towards cognitive rehabilitation for Veterans with mental illness.
|Study Type :||Observational|
|Estimated Enrollment :||104 participants|
|Official Title:||Optimizing Cognitive Remediation in VA Mental Health Rehabilitation Settings|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||January 1, 2025|
|Estimated Study Completion Date :||April 30, 2025|
Veterans engaged in VA mental health rehabilitation/recovery
Veterans must receive services in a VA Healthcare System psychosocial rehabilitation and recovery center (PRRC) or mental health residential rehabilitation treatment program (RRTP).
- Mismatch Negativity (electrophysiological biomarker) [ Time Frame: 5 years ]Mismatch negativity (micro-volts)
- Cognition [ Time Frame: 5 years ]Global age and gender corrected performance on Penn Computerized Neurocognitive Battery
- Cognitive training performance [ Time Frame: 5 years ]Performance on a 1 hour computerized cognitive training exercise
- UCSD Performance-Based Skills Assessment, brief version [ Time Frame: 5 years ]Standardized subscale scores (0-100, greater score denotes better outcome)
- WHODAS 2.0 [ Time Frame: 5 years ]World Health Organization Disability Schedule 2.0
- Service Engagement Scale [ Time Frame: 5 years ]Service Engagement Scale, 14 questions rated on 0-3 Likert scale; better outcomes are denoted by greater scores on some questions, but lower scores on others
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395157
|Contact: Yash B Joshi, MD PhD||(858) 642-3827||Yash.Joshi@va.gov|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA|
|San Diego, California, United States, 92161|
|Contact: Yash B Joshi, MD PhD 858-642-3827 Yash.Joshi@va.gov|
|Principal Investigator: Yash B. Joshi, MD PhD|
|Principal Investigator:||Yash B. Joshi, MD PhD||VA San Diego Healthcare System, San Diego, CA|