- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02447744
Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
연구 개요
상세 설명
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:
- Experience of childhood maltreatment
- With current age between 19 to 35 years old
- With current symptoms of depression or anxiety or PTSD or significant general stress.
Exclusion Criteria:
- History of psychiatric disorders with psychotic features
- Suicidal attempts during the past six months
- Neurological disorders
- And common MRI exclusion criteria
- Prior history with the mindfulness based stress reduction program or other systematic meditation programs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Mindfulness group
This arm receives an 8-week mindfulness based behavioral intervention program.
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The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
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다른: Waitlist control group
This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.
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The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Changes in Subjects' Perceived Stress Level
기간: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed. |
After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Changes of Mindfulness
기간: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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Changes in the mindfulness level as measured by the Mindful Attention Awareness Scale (post-intervention scores minus pre-intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The MAAS is a 15-item scale each responded with Likert scale 1-6; the MAAS score calculated as the mean of all items, thus the full range of the score is 1-6, with higher scores meaning more mindful. An increase in MAAS score (i.e., a positive score change )means the subject has improved after the intervention by becoming more mindful. |
After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2014P000295
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. .
Mindfulness based intervention에 대한 임상 시험
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Qazvin University Of Medical Sciences완전한
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Qazvin University Of Medical Sciences알려지지 않은
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Oregon Health and Science UniversityMedical Research Foundation, Oregon완전한