N/A
N=100
Optimizing Cognitive Remediation
Schizophrenia · Stress Disorders, Post-Traumatic · Generalized Anxiety Disorder · Mood Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04395157 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) — 40.59 T-Score — p=0.078
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) |
40.59 | 0.078 |
| PRIMARY Cognitive Training Performance-Number of Levels Completed |
14.94 | 0.009 sig |
| PRIMARY World Health Organization Disability Schedule (WHODAS 2.0) |
25.8; 23.16; 22.54; 22.87 | 0.506 |
| PRIMARY WHOQOL-BREF Total Score |
80.94; 83.95; 84.93; 84.4 | 0.817 |
Summary
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, Psychosocial Rehabilitation and Recovery Centers and other mental health treatment programs 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.
Eligibility Criteria
Inclusion Criteria
- Veterans are currently enrolled in or within 6 weeks of discharge from (as relevant): a VA San Diego Healthcare System (VASDHS) psychosocial rehabilitation and recovery center (PRRC), VASDHS mental health residential rehabilitation treatment program (RRTP), VASDHS acute inpatient hospitalization or VASDHS outpatient mental health treatment
- have a DSM-5 mental illness, including:
- schizophrenia
- schizoaffective disorder
- delusional disorder
- major depressive disorder
- bipolar disorder
- generalized anxiety disorder
- PTSD
- fluent and literate in English
- no impairment in hearing or vision
Exclusion Criteria
- active substance use within the last 30 days
- positive urine drug screen conducted as part of the screening process
- have acute/ongoing thoughts of self-harm or harming others
- intellectual disability or a neurocognitive disorder (i.e. dementia)
Data sourced from ClinicalTrials.gov (NCT04395157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.