여성의 웰빙 연구
여성의 기분을 개선하기위한 치료
Phase 2 is a randomized controlled trial of integrative yoga and mindful self-compassion program vs. women's wellbeing education for women with a history of interpersonal violence exposure and heightened distress.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
In Phase 2, the investigators will conduct a pilot randomized controlled trial (RCT) of 12 weeks of integrative yoga and mindful self-compassion training (I-YMSC) vs. 12 weeks of women's wellbeing education (WWE).
Participants will be women with a history of interpersonal violence exposure and heightened distress.
Participants will be randomized to Phase 2 groups of 12 weeks of I-YMSC or WWE. Forty-eight women will be enrolled.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- 모병
- Butler Hospital
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연락하다:
- Research Coordinator
- 전화번호: 401-455-6200, ext. 21070
- 이메일: i-ymsc.study@butler.org
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female
- Ages 18-65
- Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ])
- Report being distressed, defined by a score of >5 on the Kessler-6 screener
- Speak and understand English well enough to understand questionnaires when they are read aloud
- Have access to a telephone through owning one, a relative/friend, or an agency
- Have access to a device that will support use of the video platform we are using to conduct assessments and for home practice yoga video sessions
Exclusion Criteria:
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Inability to be physically active, determined by a score >1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation
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Planned surgery in next 6 months, as this would interfere with study participation
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Pregnancy, as yoga should be modified for pregnancy
Women who meet criteria for the following:
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Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
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Lifetime history of psychotic disorders (DIAMOND)
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Current probable severe substance use disorder (DIAMOND)
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Current diagnosis of anorexia nervosa or history in past year (DIAMOND)
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Moderate or high risk for suicide on the adapted Columbia Suicide Severity Rating Scale screen version-recent (C-SSRS) and/or endorsement of suicidal plan/intent in the past 3 months
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Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks
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Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes
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Self-report of experiencing intimate partner violence currently or within past six months (assessed by the Revised Conflict Tactics Scale 2 [R-CTS2]), as this would require a different type of intervention
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Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Integrative Yoga and Mindful Self-Compassion (I-YMSC) training
12 weeks of I-YMSC training |
Group Integrative Yoga & Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress |
|
활성 비교기: Women's Wellbeing Education (WWE)
12 weeks of group WWE |
Group women's wellbeing education for women with a history of interpersonal violence exposure and distress |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility
기간: Post intervention (month 3)
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Feasibility assessed based on number of participants who remained in the intervention (retention). |
Post intervention (month 3)
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Feasibility of Intervention Measure
기간: Post intervention (month 3)
|
The Feasibility of Intervention Measure (FIM) construct comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility. |
Post intervention (month 3)
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|
Intervention Appropriateness Measure
기간: Post intervention (month 3)
|
The Intervention Appropriateness Measure (IAM) construct comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility. |
Post intervention (month 3)
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|
Acceptability of Intervention Measure
기간: Post intervention (month 3)
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The Acceptability of Intervention Measure (AIM) comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility. |
Post intervention (month 3)
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The Client Satisfaction Questionnaire (CSQ-8)
기간: Post intervention (month 3)
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Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction. |
Post intervention (month 3)
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Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
기간: Post intervention (month 3)
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Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga. |
Post intervention (month 3)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depression Anxiety and Stress Scale (DASS-21)
기간: Baseline to post intervention (month 3)
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Distress at Month 3. The DASS-21 is a 21-item measure with each item measured on a 0-3 scale, and total score conversion ranging from 0-63. Higher global scores indicate greater psychological distress. |
Baseline to post intervention (month 3)
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공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 1871144-2
- K23AT011917 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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