Clinical trial NCT06586164: Enhancing Rehabilitation for Veterans With Serious Mental Illness
Official title: Enhancing Rehabilitation for Veterans With Serious Mental Illness Via Biomarker-Informed Cognitive Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, San Diego
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to Targeted Cognitive Training (TCT) + Treatment as Usual (TAU) or Treatment as Usual (TAU)
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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 75 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.

Primary outcomes:
measure: Clinical Symptoms - Positive and Negative Syndrome Scale (PANSS)
timeFrame: 22 weeks
measure: Cognition - Matrics Consensus Cognitive Battery (MCCB)
timeFrame: 22 weeks
measure: Function - Functional Capacity: UCSD Performance-Based Skills Assessment, Brief Version (UPSA-B)
timeFrame: 22 weeks
measure: Function - Psychosocial Recovery: World Health Organization Disability Schedule 2.0 (WHODAS)
timeFrame: 22 weeks
Secondary outcomes:
Other outcomes:
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: Gregory Light, PhD
role: PRINCIPAL_INVESTIGATOR
References: