Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women
2018년 4월 24일 업데이트: Margit I. Berman, Dartmouth-Hitchcock Medical Center
Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women: A Randomized Controlled Trial
The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself!
compared to a commercial behavioral weight loss program, Weight Watchers (WW).
Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments.
Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.
연구 개요
연구 유형
중재적
등록 (실제)
19
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New Hampshire
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Lebanon, New Hampshire, 미국, 03766
- Dartmouth-Hitchcock Medical Center
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- English-speaking
- Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV)
- Body Mass Index (BMI) greater than or equal to 30
- Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study)
Exclusion Criteria:
- current substance dependence
- history of psychotic symptoms
- high risk of suicide/self-harm
- current enrollment in a weight-loss program
- weight loss surgery in the past year
- current psychotherapy
- inability to postpone weight loss or depression treatment interventions for the duration of the study
- taking antipsychotic, tricyclic, or oral corticosteroid medication
- unwilling to be randomized to the study treatments
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Accept Yourself! Intervention
Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group
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다른 이름들:
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활성 비교기: Behavioral Weight Loss
Weight Watchers groups
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in clinician assessed depression symptoms
기간: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
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As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)
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At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
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Change in self-reported depression symptoms
기간: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
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As assessed by Patient Health Questionnaire-9 (PHQ-9)
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At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in fasting Lipids
기간: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
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At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
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Change in systolic and diastolic blood pressure
기간: At post-treatment (immediately following the three-month intervention) and 12 month follow up
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At post-treatment (immediately following the three-month intervention) and 12 month follow up
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Change in fasting blood glucose
기간: At post-treatment (immediately following the three-month intervention) and 12 month follow up
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At post-treatment (immediately following the three-month intervention) and 12 month follow up
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Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)
기간: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
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At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
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Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)
기간: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
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At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
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Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)
기간: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
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At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
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Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)
기간: At post-treatment (immediately following the three-month intervention)
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At post-treatment (immediately following the three-month intervention)
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Change in weight
기간: At post-treatment (immediately following the three-month intervention) and 12 month follow up
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Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).
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At post-treatment (immediately following the three-month intervention) and 12 month follow up
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Change in self-reported physical activity
기간: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
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At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
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Change in cardiovascular fitness as assessed by six-minute walk test
기간: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
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At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Margit I Berman, Ph.D, Dartmouth College
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
2015년 8월 12일
기본 완료 (실제)
2017년 5월 7일
연구 완료 (실제)
2017년 5월 7일
연구 등록 날짜
최초 제출
2015년 7월 14일
QC 기준을 충족하는 최초 제출
2015년 7월 15일
처음 게시됨 (추정)
2015년 7월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 24일
마지막으로 확인됨
2018년 4월 1일
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. .
Accept Yourself!에 대한 임상 시험
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University of British ColumbiaProvidence Health & Services; Vancouver Coastal Health모병
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University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)완전한
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Shahid Beheshti University of Medical Sciences완전한
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University Hospital, Toulouse모병