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NCT Number: NCT06586164

Enhancing Rehabilitation for Veterans With Serious Mental Illness

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.

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Key information

Age range

18 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This application 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 application 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.

TCT is a computerized intervention designed to sharpen the acuity and fidelity of sensory information processing through specific exercises that systematically increase demands on early perceptual and attentive processes. For many participants, TCT leads to "bottom-up" gains in perceptual functioning that lead to improvements in verbal learning and memory after 20-30h. While these benefits of TCT are evident at the group level, nearly half of all patients fail to show cognitive gains, even after extended 40-100h courses of TCT. 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.

Enrolled patients complete clinical, cognitive and functional measures and candidate EEG biomarkers at baseline, and then are assigned to Treatment As Usual (TAU) vs. TCT+TAU arms (n=40/group) using stratified random sampling. TAU consists of participation in the standard PRRC programming that includes visits with PRRC clinicians, recovery coaching, groups and psychotherapy, peer services, and supported employment. Subjects randomized to TCT + TAU will also complete 30 hours of TCT consisting of three one-hour training sessions per week. Repeat assessment will occur after TCT session #10, 20 and 30 (or after the equivalent number of weeks have passed for TAU) and again 12 weeks after the cessation of TCT to evaluate the durability of observed gains.

This project will evaluate whether PRRC outpatients receiving 30 hours of TCT will exhibit significant improvements in clinical symptoms and cognition along with psychosocial functioning and quality of life compared with the TAU group. The investigators also hypothesize that favorable responses to 30 hours of TCT will be predicted by behavioral, cognitive, and EEG-based biomarkers measured at the beginning of the study. Finally the investigators will examine the acceptability of TCT and biomarker testing, as well as barriers and facilitators to implementation from the perspective of Veterans and PRRC clinicians based on feedback from study participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: TCT

Primary outcomes

  1. Clinical Symptoms - Positive and Negative Syndrome Scale (PANSS)

    Time frame: 22 weeks

    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.

  2. Cognition - Matrics Consensus Cognitive Battery (MCCB)

    Time frame: 22 weeks

    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.

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

    Time frame: 22 weeks

    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

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

    Time frame: 22 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail A Mack

CONTACT

[email protected]

(858) 642-6492

Joyce Sprock, BS

CONTACT

[email protected]

(858) 552-8585 ext. 2261

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of California, San Diego

Registry information

Official study title

Enhancing Rehabilitation for Veterans With Serious Mental Illness Via Biomarker-Informed Cognitive Training

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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