Enhancing Rehabilitation for Veterans With Serious Mental Illness

BEHAVIORAL

Targeted Cognitive Training

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.

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.

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.

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

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.