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

1. august 2026 opdateret af: Boston University Charles River Campus

Enhancing Cognitive and Work/School Outcomes in People With First Episode Psychosis: Testing the Effectiveness of Cognitive Self-Management Strategies

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The Coordinated Specialty Care (CSC) programs in the EPINET-TX Network provide Supported Employment and Education (SEE) services for young adults between the ages of 15-32 experiencing first episode psychosis (FEP). In this pilot cluster randomized clinical trial (RCT), six CSC programs representing different geographical regions including the urban southwest (serving a majority Latino population), the urban central and southeast (serving majority African American population), and the rural north and northeast (serving a racially/ethnically mixed population) that are part of the EPINET-TX Network will be recruited. Once the 6 SEE teams have been recruited, they will be randomized using a stratified procedure based on geographic region and populations served.

The 3 SEE teams randomized to the experimental group will be trained in CSM by the Boston University (BU) research team. During the training period, the CSC team program director and SEE specialist will be trained in CSM resources and methods, beginning with an online self-paced training course, followed by weekly and then biweekly zoom-based group supervision with BU researchers. CSM sessions will be audio-recorded as part of initial training and ongoing fidelity checks. Zoom meeting training sessions will also be recorded. CSM training is expected to take approximately three months, and the participating SEE programs will be reimbursed for staff training time. Designated site CSC personnel from both the experimental and the control group sites will be trained to administer the outcome assessments.

After training of CSC teams and assessors is complete, recruitment of young adults with FEP will begin at all 6 sites simultaneously. Recruitment of young adult participants will include information meetings conducted by the program directors of participating CSC programs, consent and assent meetings, and the baseline assessment. Once identified, these program directors will be added as staff on the Institutional Review Board (IRB).

The 6 CSC teams will then administer either the experimental intervention (CSM + SEE) intervention or the control intervention (SEE only). Staff within the experimental group will continue to receive support from the BU PI's, who will periodically administer the CSM Fidelity Scale to ensure CSM intervention fidelity.

Young adult participants in both the experimental and control groups will complete assessments at baseline, 6 months, 12 months, and 18 months. These assessments will take place in person by a trained onsite assessor. The baseline assessment battery will include a demographics questionnaire, history of employment and education questionnaire, the WRAT to assess reading level, and 2 cognitive assessments (described below). Follow-up assessments will only include the cognitive measures. These assessments are expected to take between 60-90 minutes for a total of 6 hours of time.

In addition, research sites will share the results of the Core Assessment Battery (CAB), an assessment that is administered as a part of routine CSC care every six months, with the BU researchers every 6 months. Additional information about prescribed medication, SEE program utilization, and psychiatric hospitalizations is normally collected quarterly and will be shared at each assessment. Education and employment logs will be collected weekly and shared with the BU research team. This information will be collected on all young adult participants.

Young adults with FEP in the experimental group will participate in the CSM intervention. The teaching of Cognitive Self-Management Strategies (CSM) by SEE specialists includes an additional 12 sessions that range from 45 to 60 minutes long. Thus, participants in the experimental group will complete about 18 hours of study activities over an 18-month period. Those in the control group will participate in the assessments, about 6 hours of study activities over an 18-month period.

After the study is over, participants from the control group still enrolled in the CSC program will be offered CSM if appropriate to their goals.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Susan R McGurk, PhD
  • Telefonnummer: 617-353-3549
  • E-mail: mcgurk@bu.edu

Undersøgelse Kontakt Backup

  • Navn: Alexa Trolley-Hanson, MS
  • Telefonnummer: 617-353-3549
  • E-mail: athanson@bu.edu

Studiesteder

  • Forenede Stater
    • Texas
      • Big Spring, Texas, Forenede Stater, 79720
        • Rekruttering
        • West Texas Centers Promoting Behavioral and Developmental Health
        • Kontakt:
        • Ledende efterforsker:
          • Amanda Ryan, PhD
      • Granbury, Texas, Forenede Stater, 76048
        • Rekruttering
        • Pecan Valley Centers for Behavioral and Developmental Healthcare
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Molly Lopez, PhD
      • Laredo, Texas, Forenede Stater, 78041
      • Longview, Texas, Forenede Stater, 75604
        • Ikke rekrutterer endnu
        • Community Healthcore
        • Ledende efterforsker:
          • Amanda Ryan, PhD
        • Ledende efterforsker:
          • Molly Lopez, PhD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

1) Young adults who are not fluent in english

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Thinking Skills for Work-Cognitive Self-Management Program (CSM)
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.
Adfærdsmæssigt: Treatment as Usual (TAU)
In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.
Aktiv komparator: Treatment as Usual
In this arm, the 3 sites (30 participants) will participate in regular weekly SEE services.
Adfærdsmæssigt: Treatment as Usual (TAU)
In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
School and Education Activity Tracker
Tidsramme: Tracked weekly through study completion (about 18 months)
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
Tidsramme: Baseline, 6-, 12-, and 18-months
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
Tidsramme: Baseline, 6-, 12-, and 18-months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Clinical Outcomes in Measurement-based care Assessment of Symptoms and Severity (COMPASS-10)
Tidsramme: baseline, 6-, 12-,18-months
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.
baseline, 6-, 12-,18-months
The Global Functioning Social and Role Subscales
Tidsramme: Baseline, 6-, 12-, 18-months
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.
Baseline, 6-, 12-, 18-months
The Personal Wellbeing Index
Tidsramme: Baseline, 6-, 12-, and 18- months
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.
Baseline, 6-, 12-, and 18- months
The Alcohol Use Scale
Tidsramme: Baseline, 6-, 12-, and 18-months

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.
Baseline, 6-, 12-, and 18-months
The Drug Use Scale
Tidsramme: Baseline, 6-, 12-, and 18-months

This 1-item self-report scale measures a participant's drug use over the past 6 months. Participants report the following ratings:

  1. Abstinent
  2. Use with Impairment
  3. Mild Drug Use
  4. Moderate Drug Use
  5. Severe Drug Use Lower scores indicate better outcomes
Baseline, 6-, 12-, and 18-months
Substance Use Abuse Treatment Stage
Tidsramme: Baseline, 6-, 12-, and 18-months

This 1 item scale measures the extent to which a participant is engaged in treatment for their substance use. It is a self-report scale in which the participant chooses one of the following options:

  1. pre-engagement, no contact with substance use treatment services
  2. engagement, limited contact with substance use treatment services
  3. early persuasion, regular contact but no change in use
  4. late persuasion, regular contact with reductions in use
  5. early active treatment, regular contact, reductions in use for 1 month
  6. late active treatment, regular contact, reductions in use and working towards abstinence
  7. relapse prevention=regular contact, achieved abstinence for 6 months, occasional relapses
  8. remission/recovery, no problems with substance use Higher scores indicate better outcomes
Baseline, 6-, 12-, and 18-months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Demographics Form
Tidsramme: Baseline only
Standardized set of questions about a participants age, gender, race/ethnicity, gender, and diagnosis
Baseline only
History of employment and education
Tidsramme: Baseline only
Standardized set of questions about an individual's past employment and education activities
Baseline only

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boston University Charles River Campus

Samarbejdspartnere

University of Texas

Efterforskere

  • Ledende efterforsker: Susan R McGurk, PhD, Boston University Center for Psychiatric Rehabilitation
  • Ledende efterforsker: Kim Mueser, PhD, Boston University Center for Psychiatric Rehabilitation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. august 2025

Primær færdiggørelse (Anslået)

31. januar 2029

Studieafslutning (Anslået)

31. maj 2029

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. august 2026

Først opslået (Faktiske)

6. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7734E
  • 90RTEM0004 (Andet bevillings-/finansieringsnummer: Nat. Institute on Disability Indep. Living and Rehab Research)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There are no plans to share IPD from this trial

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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