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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-32
SponsorBoston University Charles River Campus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CSM plus SEE GroupExperimental treatment 2 interventions
Group B: Treatment as UsualActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Tracked weekly through study completion (about 18 months)
2

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.

Time frame
Baseline, 6-, 12-, and 18-months
3

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.

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

Secondary outcomes

1

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

This 10-item clinician-rated instrument evaluates positive, negative, and affective symptom severity for individuals experiencing early-phase or first-episode psychotic disorders. Rated on a scale from 0 (not present) to 6 (very severe). Lower values indicate treatment progress in this study.

Time frame
baseline, 6-, 12-,18-months
2

The Global Functioning Social and Role Subscales

This 2 item scale measure was designed for young adults and measures a participant's social connections and daily responsibilities. This clinician-rated scale is scored from 1 to 10, where higher numbers indicate better outcomes.

Time frame
Baseline, 6-, 12-, 18-months
3

The Personal Wellbeing Index

This is a self-report, 8-item scale, that measures life satisfaction across standard of living, personal health, and relationships. Scores range from 0 (low-wellbeing) to 10 (high-wellbeing). Higher scores indicate better outcomes in this study.

Time frame
Baseline, 6-, 12-, and 18- months
4

The Alcohol Use Scale

This study uses 1 item from this scale, "Please rate your worst 1 month over the past 6 months." Participants report the following ratings: 1. Abstinent 2. Use with Impairment 3. Mild Alcohol Use 4. Moderate Alcohol Use 5. Severe Alcohol Use Lower scores indicate better outcomes.

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

Other outcomes

1

Demographics Form

Standardized set of questions about a participants age, gender, race/ethnicity, gender, and diagnosis

Time frame
Baseline only
2

History of employment and education

Standardized set of questions about an individual's past employment and education activities

Time frame
Baseline only

Sponsors and contacts

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