Optimizing Cognitive Remediation

Active, not recruiting

• Conditions: Schizophrenia; Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder; Mood Disorders

• Registration Number: NCT04395157
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description

This is an observational, non-interventional study. Veterans with mental health diagnoses currently engaged in, or within 6 weeks of discharge from VA Mental Health Residential Rehabilitation Treatment Programs (RRTP), Psychosocial Rehabilitation and Recovery Centers (PRRC), and other mental health treatment settings (inpatient or outpatient mental healthcare) will be recruited. Veterans 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 in VA rehabilitation milieus and programs; 2) Determine whether MMN is linked to cognition and predicts cognitive remediation exercise performance in a heterogeneous group of Veterans with mental illness. The proposal will also assess feasibility and acceptability of using biomarker-guided cognitive rehabilitation interventions in VA mental health rehabilitation settings.

Information gained from this study will help establish a precision-medicine approach towards cognitive rehabilitation for Veterans with mental illness.

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Study Start: 2020-12-01
• Status Verified: 2025-01
• Primary Completion: 2025-01-01
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-16
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mismatch Negativity (electrophysiological biomarker)	3 months	Mismatch negativity (micro-volts)
Cognition	3 months	Performance on MATRICS Consensus Cognitive Battery
Cognitive training performance	3 months	Performance on a 1 hour computerized cognitive training exercise
WHOQOL-BREF	3 months	Scores on the World Health Organization Quality of Life scale
WHODAS 2.0	3 months	World Health Organization Disability Schedule 2.0

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States