Optimizing Cognitive Remediation

Schizophrenia Clinical Trial

Official title:

Optimizing Cognitive Remediation in VA Mental Health Rehabilitation Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04395157
• Other study ID #: D3395-W
• Secondary ID: 1IK2RX003395
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Yash B Joshi, MD PhD
• Phone: (858) 642-3827
• Email: Yash.Joshi[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: April 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 po — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mismatch Negativity (electrophysiological biomarker)	Mismatch negativity (micro-volts)	5 years
Secondary	Cognition	Performance on MATRICS Consensus Cognitive Battery	5 years
Secondary	Cognitive training performance	Performance on a 1 hour computerized cognitive training exercise	5 years
Secondary	WHOQOL-BREF	Scores on the World Health Organization Quality of Life scale	5 years
Secondary	WHODAS 2.0	World Health Organization Disability Schedule 2.0	5 years