Enhancing Rehabilitation for Veterans With Serious Mental Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-83
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Targeted Cognitive Training
BehavioralTCT 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: TCT + TAUActive comparator 1 intervention
Group B: TAUNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
22 weeks2
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.
Time frame
22 weeks3
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
Time frame
22 weeks4
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.
Time frame
22 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
University of California, San Diego
Collaborator
Source ClinicalTrials.gov