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

2026년 8월 1일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Susan R McGurk, PhD
  • 전화번호: 617-353-3549
  • 이메일: mcgurk@bu.edu

연구 연락처 백업

  • 이름: Alexa Trolley-Hanson, MS
  • 전화번호: 617-353-3549
  • 이메일: athanson@bu.edu

연구 장소

  • 미국
    • Texas
      • Big Spring, Texas, 미국, 79720
        • 모병
        • West Texas Centers Promoting Behavioral and Developmental Health
        • 연락하다:
        • 수석 연구원:
          • Amanda Ryan, PhD
      • Granbury, Texas, 미국, 76048
        • 모병
        • Pecan Valley Centers for Behavioral and Developmental Healthcare
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Molly Lopez, PhD
      • Laredo, Texas, 미국, 78041
      • Longview, Texas, 미국, 75604
        • 아직 모집하지 않음
        • Community Healthcore
        • 수석 연구원:
          • Amanda Ryan, PhD
        • 수석 연구원:
          • Molly Lopez, PhD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
행동: Treatment as Usual (TAU)
In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.
활성 비교기: Treatment as Usual
In this arm, the 3 sites (30 participants) will participate in regular weekly SEE services.
행동: Treatment as Usual (TAU)
In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
School and Education Activity Tracker
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
The Clinical Outcomes in Measurement-based care Assessment of Symptoms and Severity (COMPASS-10)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Demographics Form
기간: Baseline only
Standardized set of questions about a participants age, gender, race/ethnicity, gender, and diagnosis
Baseline only
History of employment and education
기간: Baseline only
Standardized set of questions about an individual's past employment and education activities
Baseline only

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boston University Charles River Campus

협력자

University of Texas

수사관

  • 수석 연구원: Susan R McGurk, PhD, Boston University Center for Psychiatric Rehabilitation
  • 수석 연구원: Kim Mueser, PhD, Boston University Center for Psychiatric Rehabilitation

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 10일

기본 완료 (추정된)

2029년 1월 31일

연구 완료 (추정된)

2029년 5월 31일

연구 등록 날짜

최초 제출

2026년 5월 13일

QC 기준을 충족하는 최초 제출

2026년 8월 1일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 1일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 7734E
  • 90RTEM0004 (기타 보조금/기금 번호: Nat. Institute on Disability Indep. Living and Rehab Research)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

There are no plans to share IPD from this trial

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다