Optimizing Cognitive Remediation

Optimizing Cognitive Remediation in VA Mental Health Rehabilitation Settings

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Stress Disorders, Post-Traumatic

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 Type: Observational
• Enrollment (Estimated): 104

Contacts and Locations

• Study Contact: Name: Yash B Joshi, MD PhD; Phone Number: (858) 642-3827; Email: Yash.Joshi@va.gov

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • Recruiting
      • VA San Diego Healthcare System, San Diego, CA
      • Contact: Yash B Joshi, MD PhD; Phone Number: 858-642-3827; Email: Yash.Joshi@va.gov
      • Principal Investigator: Yash B. Joshi, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Veterans engaged in VA mental health rehabilitation/recovery; Veterans must be within 6 weeks of discharge from or current receive mental health treatment services in a VA San Diego Healthcare System psychosocial rehabilitation and recovery center (PRRC), mental health residential rehabilitation treatment program (RRTP), general mental health outpatient treatment, or recent acute mental health inpatient hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mismatch Negativity (electrophysiological biomarker)	Mismatch negativity (micro-volts)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	Performance on MATRICS Consensus Cognitive Battery	5 years
Cognitive training performance	Performance on a 1 hour computerized cognitive training exercise	5 years
WHOQOL-BREF	Scores on the World Health Organization Quality of Life scale	5 years
WHODAS 2.0	World Health Organization Disability Schedule 2.0	5 years

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Yash B. Joshi, MD PhD, VA San Diego Healthcare System, San Diego, CA

Publications and helpful links

General Publications

• Joshi YB, Gonzalez CE, Molina JL, MacDonald LR, Min Din J, Minhas J, Leposke T, Nordberg B, Li F, Talledo J, Sprock J, Swerdlow NR, Light GA. Mismatch negativity predicts initial auditory-based targeted cognitive training performance in a heterogeneous population across psychiatric disorders. Psychiatry Res. 2023 Sep;327:115215. doi: 10.1016/j.psychres.2023.115215. Epub 2023 Apr 20.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Cognition; Electroencephalography
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Schizophrenia; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: D3395-W; 1IK2RX003395 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No