- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06295250
ASHA 방글라데시 - 빈곤과 우울증 해결을 위한 통합 개입
2024년 5월 1일 업데이트: Alison Karasz, University of Massachusetts, Worcester
ASHA 방글라데시 - 저소득 농촌 여성의 우울증을 해결하기 위한 통합 개입
이 무작위 대조 시험의 목표는 우울증이 있는 저소득 시골 방글라데시 여성을 대상으로 빈곤 완화와 우울증 치료를 결합한 통합 개입의 효과를 우울증 치료 단독과 비교하는 것입니다.
이 연구에서 대답하려는 주요 질문은 다음과 같습니다. 1) 통합 개입으로 우울증 치료에 빈곤 완화를 추가하면 우울증 증상과 재발 여부에 따라 평가할 때 24개월 후 우울증 결과가 개선되는지 여부; 2) 우울증 치료에 빈곤 완화를 추가하면 치료 활용 및 유지를 포함한 시행 결과가 향상되는지 여부.
양팔의 참가자들은 6개월, 12개월, 18개월, 24개월에 인터뷰에 참여하게 된다.
연구 개요
연구 유형
중재적
등록 (추정된)
660
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Alison Karasz, PhD
- 전화번호: 3478435652
- 이메일: alison.karasz@umassmed.edu
연구 장소
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Dhaka, 방글라데시
- 모병
- International Centre for Diarrhoeal Disease Research
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연락하다:
- Fahmida Tofail, MBBS, PhD
- 이메일: ftofail@icddrb.org
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 기혼 여성;
- 18~75세;
- 벵골어에 능통함)
- 경제 취약성 지수(Economic Vulnerability Index) 기준 충족
- 환자 건강 설문지에서 >=10(기준선에서 PHQ-9 우울증 척도)
제외 기준:
- 사전 동의를 제공할 수 없음
- 24M 기간 동안 1개월 이상 여행할 계획입니다.
- 기타 사유로 연구에 참여할 수 없음
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 우울증 치료(DT)
통제그룹의 참가자들은 6개월 동안 수동화된 그룹 기반 심리치료를 받게 됩니다.
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수동화된 그룹 기반 심리치료.
세계보건기구(WHO) 문제 관리 플러스(PM+) 개입에서 채택된 이 개입에는 행동 활성화, 사회적 지원 강화 및 문제 관리가 포함됩니다.
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실험적: 통합 개입
실험 부문에는 다음 두 가지 요소가 포함됩니다.
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이 개입에는 자산 이전, 기술 이전, 금융 지식 교육, 급여, 저축 계좌, 수의학 지원, 사료 및 농업 훈련이 포함됩니다.
수동화된 그룹 기반 심리치료.
세계보건기구(WHO) 문제 관리 플러스(PM+) 개입에서 채택된 이 개입에는 행동 활성화, 사회적 지원 강화 및 문제 관리가 포함됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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24개월 우울증 증상의 변화
기간: 24개월
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우울증 증상을 평가하기 위해 고안된 9개 항목 설문지인 환자 건강 설문지로 측정한 기준 시점부터 기준 시점 이후 24개월까지의 증상 변화.
최소 점수는 0입니다. 최대 점수는 27입니다.
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24개월
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중간 시점의 우울 증상 변화
기간: 6, 12, 18개월
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우울증 증상을 평가하기 위해 고안된 9개 항목 설문지인 환자 건강 설문지로 측정한 기준 시점부터 기준 시점 이후 6, 12, 18개월까지의 증상 변화.
최소 점수는 0입니다. 최대 점수는 27입니다.
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6, 12, 18개월
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24개월 재발
기간: 24개월
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재발은 6개월에 관해를 달성한 참가자 중 환자 건강 설문지의 A 점수 >= 10으로 정의됩니다.
재발을 평가하기 위해 조사관은 이전 데이터 수집 시점 이후 언제든지 우울증 증상의 경험에 대해 참가자에게 질문할 것입니다.
데이터 수집은 24개월 재발 또는 2번째(6개월) 이후 언제든지 재발의 존재에 초점을 둘 것입니다.
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24개월
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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경제적 취약성
기간: 기준선, 12개월 및 24개월
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소득, 자산, 부채, 식량 불안, 재정적 걱정을 포함하는 경제적 취약성에 대한 종합 지수입니다.
이 측정값은 고정된 점수가 없지만 현장에서 수집된 데이터를 기반으로 실용적인 접근 방식을 사용하여 구성됩니다.
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기준선, 12개월 및 24개월
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불안
기간: 기준선, 6개월, 12개월, 24개월
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일반 불안 장애 척도(0~231점의 7개 항목 설문지)로 측정된 불안 증상.
점수가 높을수록 불안감이 더 크다는 것을 의미합니다.
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기준선, 6개월, 12개월, 24개월
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기능
기간: 기준선, 6개월, 12개월, 24개월
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세계보건기구 장애 평가 일정(World Health Organization Disability Assessment Schedule)에 의해 측정된 기능 및 장애는 12-60점으로 점수가 매겨진 12개 항목 설문지로, 점수가 높을수록 장애가 더 심함을 의미합니다.
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기준선, 6개월, 12개월, 24개월
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장력 척도
기간: 기준선, 6개월, 12개월, 18개월 및 24개월
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심리적 증상과 신체적 문화적 증상을 모두 측정하는 설문지: 0~3점으로 측정된 39개 항목으로 최소 점수는 0점, 최대 점수는 117점입니다. 점수가 높을수록 고통 수준이 높음을 나타냅니다.
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기준선, 6개월, 12개월, 18개월 및 24개월
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유럽의 삶의 질 5차원 5단계 척도
기간: 기준선, 6개월, 12개월, 24개월
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이동성, 자기 관리, 일상 활동, 통증/불편함, 불안/우울 등 5가지 차원을 포함하는 삶의 질 측정으로 0~100점으로 점수가 매겨지며 점수가 높을수록 삶의 질이 더 좋음을 의미합니다.
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기준선, 6개월, 12개월, 24개월
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
구현 결과 - 채택
기간: 기준 + 30일
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>-1 치료 세션/# 참가자에 참석하는 참가자 수는 무작위입니다.
채용 및 학습 기록을 기준으로 합니다.
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기준 + 30일
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구현 결과 - 타당성
기간: 6개월
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참여자 비율 >= 개입 세션의 75% - 연구 기록에 근거
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6개월
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구현 결과 - 충실도
기간: 개입 1, 3, 6개월
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세션에 대한 감독관 관찰의 충실도는 준비성(0-3), 촉진(0-11), 참여(0-6), 시간 관리(0-1) 및 문서화(0-1)를 포함하는 LIKERT 척도를 사용하여 평가됩니다.
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개입 1, 3, 6개월
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Alison Karasz, PhD, Umass Chan Medical School
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
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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)
2024년 3월 15일
기본 완료 (추정된)
2026년 12월 30일
연구 완료 (추정된)
2027년 12월 30일
연구 등록 날짜
최초 제출
2024년 2월 27일
QC 기준을 충족하는 최초 제출
2024년 2월 27일
처음 게시됨 (실제)
2024년 3월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2024년 5월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2024년 5월 1일
마지막으로 확인됨
2024년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STUDY00001114
- 7R01MH127577 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
우리는 식별되지 않은 데이터 세트를 생성할 것이며 이러한 데이터에 쉽게 접근하고 사용할 수 있도록 하는 것이 우리의 의도입니다.
우리는 추가/2차 분석을 위해 다른 연구자들과 협력하고 데이터를 제공할 것입니다.
다양한 목적을 위해 제안된 데이터 세트의 추가 데이터 마이닝을 안내하고 장려하기 위해 공식 데이터 공유 계약이 개발될 것입니다.
이러한 모든 데이터 요청은 데이터의 윤리적 사용을 보장하기 위해 ICDDRB를 포함한 조사팀의 승인을 받게 됩니다.
IPD 공유 기간
분석이 완료된 후에도 데이터는 무기한으로 제공됩니다.
IPD 공유 액세스 기준
시험 IPD에 대한 액세스는 독립적인 과학 연구에 참여하는 자격을 갖춘 연구자가 요청할 수 있으며, 연구 제안 및 통계 분석 계획(SAP)의 검토 및 승인, 데이터 공유 계약(DSA) 실행 후에 제공됩니다.
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
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. .