Clinical trial NCT04395157: Optimizing Cognitive Remediation
Official title: Optimizing Cognitive Remediation in VA Mental Health Rehabilitation Settings
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Schizophrenia
Stress Disorders, Post-Traumatic
Generalized Anxiety Disorder
Mood Disorders
Keywords: Electroencephalography
Cognition
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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

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.

Eligibility 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)

Primary outcomes:
measure: Mismatch Negativity (electrophysiological biomarker)
timeFrame: 3 months
measure: Cognition
timeFrame: 3 months
measure: Cognitive training performance
timeFrame: 3 months
measure: WHOQOL-BREF
timeFrame: 3 months
measure: WHODAS 2.0
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Feasibility and acceptability of using biomarker-guided cognitive rehabilitation interventions in VA rehabilitation settings
timeFrame: 3 months
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Yash B. Joshi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.