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Optimizing Cognitive Remediation

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ClinicalTrials.gov Identifier: NCT04395157
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.


Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Other
Time Perspective: Other
Official Title: Optimizing Cognitive Remediation in VA Mental Health Rehabilitation Settings
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Mismatch Negativity (electrophysiological biomarker) [ Time Frame: 5 years ]
    Mismatch negativity (micro-volts)


Secondary Outcome Measures :
  1. Cognition [ Time Frame: 5 years ]
    Performance on MATRICS Consensus Cognitive Battery

  2. Cognitive training performance [ Time Frame: 5 years ]
    Performance on a 1 hour computerized cognitive training exercise

  3. WHOQOL-BREF [ Time Frame: 5 years ]
    Scores on the World Health Organization Quality of Life scale

  4. WHODAS 2.0 [ Time Frame: 5 years ]
    World Health Organization Disability Schedule 2.0


Biospecimen Retention:   Samples Without DNA
Electrophysiological data

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Yash B Joshi, MD PhD (858) 642-3827 Yash.Joshi@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
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         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Yash B. Joshi, MD PhD VA San Diego Healthcare System, San Diego, CA
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04395157    
Other Study ID Numbers: D3395-W
1IK2RX003395 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Electroencephalography
Cognition
Rehabilitation
Additional relevant MeSH terms:
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Schizophrenia
Stress Disorders, Post-Traumatic
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders