Enhancing Cognitive and Work/School Outcomes in First Episode Psychosis Using Cognitive Self-Management Strategies
Part of paid clinical trials in Big Spring, Texas.
- Sponsor
- Boston University Charles River Campus
- Study ID
- NCT07749105
- Status
- Recruiting
Conditions
- First Episode Psychosis (FEP)
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 32 Years
- Healthy Volunteers
- Not accepted
Interventions
- Thinking Skills for Work-Cognitive Self-Management Program (CSM) — BEHAVIORALCSM is a 12-session program that promotes the development of specific cognitive strategies to promote success in employment and education outcomes. This is a standardized, evidence-based intervention with adults with serious mental illness. Each session is facilitated by a trained cognitive specialist and lasts between 45- 60 minutes. Session topics include self-assessment of cognitive skills, recognizing strengths, challenging negative thoughts, attention and concentration, memory, organization, planning, and thinking ahead.
- Treatment as Usual (TAU) — BEHAVIORALIn this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.
Study Details
The goal of this pilot cluster randomized trial is to understand if adding a standardized cognitive self-management program, Thinking Skills for Work-Cognitive Self-Management Strategies (CSM) to Coordinated Specialty Care Supported Employment and Education (SEE) programs improves the work and school outcomes of young adults experiencing first episode psychosis. The main questions it aims to answer are: * Does adding the CSM program to usual SEE services lead to improved work and school outcomes, such as ability to find a job or enroll in school, or ability to keep a job or stay in school? * Does adding the CSM program to usual SEE services improve cognition and cognitive self-efficacy? Researchers will recruit six research sites and these will be randomized to either treatment as usual, where they will offer regular SEE services, or the experimental groups, where they will offer regular SEE services plus the CSM program. Participants in both groups will be asked to complete a brief assessment at baseline, 6-months, 12-months, and 18-months. Participants in the experimental group will be asked to participate in the 12-session CSM program in addition to their regular SEE services.
Key Dates
- First listed
- Aug 6, 2026
- Start date
- Aug 10, 2025
- Status verified
- Aug 2026
- Primary completion
- Jan 31, 2029
- Completion
- May 31, 2029
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CSM plus SEE GroupThe 3 sites (30 participants) from this site will receive the standardized 12 session CSM program in addition to regular SEE services. The CSM sessions will occur weekly and last between 45-60 minutes. They cover 12 different areas of cognition such as self-assessment, recognizing strengths, challenging negative thinking, attention and concentration, memory organization, planning ahead, problem-solving, and thinking speed.
- Active Comparator: Treatment as UsualIn this arm, the 3 sites (30 participants) will participate in regular weekly SEE services.
Primary Outcome Measure
School and Education Activity Tracker [ Time Frame: Tracked weekly through study completion (about 18 months) ]
Central Contacts
- Susan R McGurk, PhD617-353-3549
- Alexa Trolley-Hanson, MS617-353-3549
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| West Texas Centers Promoting Behavioral and Developmental Health | Big Spring | Texas | 79720 | Amanda Ryan, PhD (PRINCIPAL_INVESTIGATOR) |
| Pecan Valley Centers for Behavioral and Developmental Healthcare | Granbury | Texas | 76048 | Amanda Ryan, PhD Molly Lopez, PhD (PRINCIPAL_INVESTIGATOR) |
| Border Region Behavioral Health Care | Laredo | Texas | 78041 | Amanda Ryan, PhD Molly Lopez, PhD (PRINCIPAL_INVESTIGATOR) |
| Community Healthcore | Longview | Texas | 75604 | Amanda Ryan, PhD (PRINCIPAL_INVESTIGATOR) Molly Lopez, PhD (PRINCIPAL_INVESTIGATOR) |
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