Enhancing Rehabilitation for Veterans With Serious Mental Illness

NCT06586164 | Recruiting

• 2 other identifiers: D5058-RH230094
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This study aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.

Conditions

Schizophrenia; Psychosis; Serious Mental Illness; PTSD; Schizoaffective Disorder; Bipolar Disorder

Keywords

schizophrenia; psychosis; cognition; EEG; Serious mental illness; PTSD; Schizoaffective disorder; Bipolar disorder; clinical symptoms; function

Outcome Measures

Primary Outcomes (4)

• Clinical Symptoms - Positive and Negative Syndrome Scale (PANSS)

  Change from baseline clinical symptoms Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) will used to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of SZ. The PANSS is a 30-item scale arranged as 7 positive symptom subscale items, 7 negative symptom subscale items, and 16 general psychopathology symptom items. Each item has a definition and a basis for rating. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). On the PANSS lower values are considered to be a better outcome.

  22 weeks

• Cognition - Matrics Consensus Cognitive Battery (MCCB)

  Change from baseline cognition Matrics Consensus Cognitive Battery (MCCB) performance Change in Matrics Consensus Cognitive Battery (MCCB) performance from baseline is the outcome measure for cognition (using age- and gender-corrected T scores). The MCCB measures 7 cognitive domains: speed of processing, attention/vigilance, working memory (verbal and nonverbal), verbal learning, visual learning, reasoning/ problem solving and social cognition. MCCB verbal learning T-score is the primary cognitive outcome measure. Other MCCB domain T- scores will be used in secondary analyses. On the MCCB higher scores are indicative of better outcome.

  22 weeks

• Function - Functional Capacity: UCSD Performance-Based Skills Assessment, Brief Version (UPSA-B)

  Functional Capacity will be assessed with the UCSD Performance-Based Skills Assessment, Brief Version (UPSA-B) at study entry and assessment intervals. The UPSA takes \~15 min to complete and incorporates role play to assess functional capacity in four broad domains: planning recreational activities, finances, communication and transportation. Raw scores on each subtest are transformed into a standardized subscale scores (0-25), which are summated to an overall

  22 weeks

• Function - Psychosocial Recovery: World Health Organization Disability Schedule 2.0 (WHODAS)

  World Health Organization Disability Schedule 2.0 (WHODAS) will be used to assess psychosocial recovery. This detailed assessment consists of a 36-item questionnaire, where patients rate various aspects on a 5-point Likert scale. It covers six critical domains: cognition, mobility, self-care, social interactions, life activities, and societal participation. The WHODAS 2.0 will be used as an outcome measure for psychosocial recovery. Lower scores indicate better outcome on the WHODAS 2.0.

  22 weeks

Study Arms (2)

TCT + TAU

ACTIVE COMPARATOR

Subjects will complete 30 hours of Targeted Cognitive Training (TCT) in addition to their Treatment as Usual (TAU)

Behavioral: Targeted Cognitive Training

TAU

NO INTERVENTION

Subjects will participate in their standard Treatment as Usual (TAU) PRRC program

Interventions

Targeted Cognitive Training BEHAVIORAL

TCT is a computer-based cognitive training program in which participants train on progressively more difficult auditory processing exercises in order to improve speed, accuracy and fidelity of auditory information processing in order to generate gains in cognition and functioning.

Also known as: TCT

TCT + TAU

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans with SMI (e.g., schizophrenia, schizoaffective disorder, bipolar disorder, PTSD) being treated at PRRCs or co-located rehabilitative services.
• Age 18 and 83 years.
• Fluency in spoken and written English.
• Ability to detect 1000 Hz tones binaurally at a 40-dB sound pressure level.
• Ability to see with an acuity of 20/40 with both eyes tested together (corrected if applicable) by a standard printed Snellen eye chart reading card.

You may not qualify if:

• Estimated premorbid IQ below 70, as estimated via the WRAT-4 Reading subtest.
• Active substance use other than cannabis within the last 30 days as determined by CPRS review, self- report, or positive urine drug screen (obtained as part of the screening process).
• History of significant medical or neurological illness.
• Inability to comprehend or provide informed consent.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, San Diego: collaborator

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Stress Disorders, Post-Traumatic; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Gregory Light, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce Sprock, BS

CONTACT

(858) 552-8585; joyce.sprock@va.gov

Abigail A Mack

CONTACT

(858) 642-6492; abigail.mack@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to Targeted Cognitive Training (TCT) + Treatment as Usual (TAU) or Treatment as Usual (TAU)

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)