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Optimizing Cognitive Remediation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395157
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
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 and Psychosocial Rehabilitation and Recovery Centers 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 within 4 weeks of starting services in VA Mental Health Residential Rehabilitation Treatment Programs (RRTP) and Psychosocial Rehabilitation and Recovery Centers (PRRC) will be recruited. Veterans with PTSD and psychosis-spectrum illnesses engaged in RRTPs and PRRCs 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 and treatment engagement in VA rehabilitation milieus; 2) Determine whether MMN is linked to cognition and predicts cognitive remediation exercise performance in a heterogenous group of Veterans with mental illness. The proposal will also assess feasibility and acceptability of using biomarker-guided cognitive rehabilitation interventions in VA rehabilitation settings.

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

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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
Estimated Study Start Date : August 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


Group/Cohort
Veterans engaged in VA mental health rehabilitation/recovery
Veterans must receive services in a VA Healthcare System psychosocial rehabilitation and recovery center (PRRC) or mental health residential rehabilitation treatment program (RRTP).



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 ]
    Global age and gender corrected performance on Penn Computerized Neurocognitive Battery

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

  3. UCSD Performance-Based Skills Assessment, brief version [ Time Frame: 5 years ]
    Standardized subscale scores (0-100, greater score denotes better outcome)

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

  5. Service Engagement Scale [ Time Frame: 5 years ]
    Service Engagement Scale, 14 questions rated on 0-3 Likert scale; better outcomes are denoted by greater scores on some questions, but lower scores on others


Biospecimen Retention:   Samples Without DNA
Electrophysiological data


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 must receive services in a VA San Diego Healthcare System (VASDHS) psychosocial rehabilitation and recovery center (PRRC) or mental health residential rehabilitation treatment program (RRTP) to be enrolled in the study.
Criteria

Inclusion Criteria:

  • Veterans are within 4 weeks of entry in a VA San Diego Healthcare System (VASDHS) psychosocial rehabilitation and recovery center (PRRC) /mental health residential rehabilitation treatment program (RRTP)
  • 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)

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
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
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04395157    
Other Study ID Numbers: D3395-W
1 IK2 RX003395 ( Other Grant/Funding Number: VA ORD, Rehabilitation Research & Development )
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
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