Enhancing Cognitive and Work/School Outcomes in First Episode Psychosis Using Cognitive Self-Management Strategies

NCT07749105 | Recruiting

• 2 other identifiers: 7734E90RTEM0004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

First Episode Psychosis (FEP)

Keywords

Young adults; First Episode Psychosis; Supported Employment and Education; Cognitive remediation

Outcome Measures

Primary Outcomes (3)

• School and Education Activity Tracker

  This qualitative measure tracks the participant's participation in education or employment activities on a weekly basis. It includes questions about the education or employment activity and the time spent completing the activity. The minimal value is 0, there is no maximum value.

  Tracked weekly through study completion (about 18 months)

• The Cognitive Problems and Strategies Assessment

  Standardized measure that assesses cognitive functioning and strategy use. It includes two subscales, the "Cognitive Problems Subscale" and the "Strategy Use Subscale", each consisting of 30 items that are scored from 0-3 (cumulative 0-90). A higher score on the Cognitive Problems Subscale indicates a worse outcome, whereas higher scores on the Strategy Use Subscale indicate better outcomes.

  Baseline, 6-, 12-, and 18-months

• Cognitive Self-Efficacy Scale

  Standardized measure that assesses an individual's confidence in everyday cognitive tasks. This is a 10 item scale with values ranging from 0 to 100, with higher values indicating better outcomes.

  Baseline, 6-, 12-, and 18-months

Secondary Outcomes (6)

• The Clinical Outcomes in Measurement-based care Assessment of Symptoms and Severity (COMPASS-10)

  baseline, 6-, 12-,18-months

• The Global Functioning Social and Role Subscales

  Baseline, 6-, 12-, 18-months

• The Personal Wellbeing Index

  Baseline, 6-, 12-, and 18- months

• The Alcohol Use Scale

  Baseline, 6-, 12-, and 18-months

• The Drug Use Scale

  Baseline, 6-, 12-, and 18-months

Other Outcomes (2)

• Demographics Form

  Baseline only

• History of employment and education

  Baseline only

Study Arms (2)

CSM plus SEE Group

EXPERIMENTAL

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.

Behavioral: Thinking Skills for Work-Cognitive Self-Management Program (CSM); Behavioral: Treatment as Usual (TAU)

Treatment as Usual

ACTIVE COMPARATOR

In this arm, the 3 sites (30 participants) will participate in regular weekly SEE services.

Behavioral: Treatment as Usual (TAU)

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.

CSM plus SEE Group

Treatment as Usual (TAU) BEHAVIORAL

In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.

CSM plus SEE Group; Treatment as Usual

Eligibility Criteria

• Age: 15 Years - 32 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• currently in their first 18 months of enrollment in the CSC program
• at least 15 years of age
• receiving SEE services but not employed or enrolled in school
• have the desire to work or resume school.

You may not qualify if:

• \) Young adults who are not fluent in english

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• University of Texas: collaborator

Study Sites (4)

West Texas Centers Promoting Behavioral and Developmental Health

Big Spring, Texas, 79720, United States

RECRUITING

Pecan Valley Centers for Behavioral and Developmental Healthcare

Granbury, Texas, 76048, United States

RECRUITING

Border Region Behavioral Health Care

Laredo, Texas, 78041, United States

RECRUITING

Community Healthcore

Longview, Texas, 75604, United States

NOT YET RECRUITING

Related Publications (2)

• McGurk SR, Mueser KT, Xie H, Bloch P, DeTore NR, Pashka N, Guarino S, Ruiz A, Elliot C, Gagnon H, Bailey E, Fraser V, Welsh J, Cunningham H, Rizzano L, Wolfe R, Drake RE. A dismantling study of comprehensive cognitive remediation for improving employment outcomes: what is the role of computer cognitive training? Psychol Med. 2025 Jul 22;55:e208. doi: 10.1017/S0033291725100986.

  PMID: 40692495 BACKGROUND

• McGurk, S. R., & Mueser, K. T. (2021). Cognitive Remediation for Successful Employment and Psychiatric Recovery: The Thinking Skills for Work Program. Guilford Press.

  BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Susan R McGurk, PhD

  Boston University Center for Psychiatric Rehabilitation

  PRINCIPAL INVESTIGATOR

• Kim Mueser, PhD

  Boston University Center for Psychiatric Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan R McGurk, PhD

CONTACT

617-353-3549; mcgurk@bu.edu

Alexa Trolley-Hanson, MS

CONTACT

617-353-3549; athanson@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot cluster randomized controlled trial involving six research sites.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: August 6, 2026
• Study Start: August 10, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)