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) — BEHAVIORAL
    CSM 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) — BEHAVIORAL
    In 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 Group
    The 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 Usual
    In 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

Locations (4)

FacilityCityStateZIPSite coordinators
West Texas Centers Promoting Behavioral and Developmental HealthBig SpringTexas79720
Monique Gusman
1-800-852-2193
Amanda Ryan, PhD (PRINCIPAL_INVESTIGATOR)
Pecan Valley Centers for Behavioral and Developmental HealthcareGranburyTexas76048
David Risner
817-579-4400
Amanda Ryan, PhD
Molly Lopez, PhD (PRINCIPAL_INVESTIGATOR)
Border Region Behavioral Health CareLaredoTexas78041
Janie Hernandez
956-794-3178
Amanda Ryan, PhD
Molly Lopez, PhD (PRINCIPAL_INVESTIGATOR)
Community HealthcoreLongviewTexas75604
Jaime Jaggers
903-237-2326
Amanda Ryan, PhD (PRINCIPAL_INVESTIGATOR)
Molly Lopez, PhD (PRINCIPAL_INVESTIGATOR)

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