NCT06586164

Enhancing Rehabilitation for Veterans With Serious Mental Illness

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 83 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-25
• Primary completion: 2028-08-31
• Completion: 2028-10-31
• First posted: 2024-09-19
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States