- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00998959
Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients
Feasibility and Efficacy of a Stress Reduction Intervention for Enhancing Treatment Outcome for Depressed Minority Patients
연구 개요
상태
정황
상세 설명
The purpose of this study is to determine the usefulness of a stress reduction treatment compared to psychoeducation in helping minority patients with major depression get better.
The study will last 10 weeks. During the main portion of the study, subjects will receive either individual weekly sessions of stress-reduction therapy or psychoeducation for six weeks. The stress reduction therapy will consist of mindfulness-based stress reduction and problem solving therapy, which focuses on linking psychological problems with psychosocial issues and helping you use your skills and resources to improve your functioning. The psychoeducation will consist of six sessions of education on depression and the treatment and management of symptoms. Each session will last 50 minutes, and four of the visits will also include filling out questionnaires which will take approximately 15-30 minutes to complete. One month after the last session, subjects will come in for a follow-up visit with a study clinician to see how they are doing and to fill out questionnaires.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Meet criteria for current major depressive disorder
- Men or women aged 18-75 who self-identify as a member of a racial or ethnic minority group
- Has a PCP, therapist, psychiatrist, etc aware of their depression. Or, subject agrees to seek outside mental health treatment/management
Exclusion Criteria:
- Pregnancy
공부 계획
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 |
|---|---|
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실험적: Mindfulness based stress reduction and problem solving therapy
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Participants will receive six individual weekly 50-minute sessions of mindfulness based stress reduction (MBSR) as well as problem solving therapy (PST.
PST is a type of therapy that focuses on psychosocial problems and using your skills and resources to function better.
MBSR uses exercises in mindfulness to reduce stress.
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다른: Psychoeducation
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Participants will receive six individual weekly 50-minute sessions of psychoeducation.
Psychoeducation consists of education on depression, its symptoms, its treatment, and recovery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Feasibility (rate of enrollment, attrition)
기간: 2 years
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceived stress
기간: Week 10
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We will assess perceived stress at week 10 of subjects' study participation, although we allow for a 12-week period for subjects to complete the study.
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Week 10
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Trina E. Chang, MD, Massachusetts General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .