Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder (EYIPTSD)
2013년 3월 19일 업데이트: Sat Bir Khalsa, PhD, Brigham and Women's Hospital
The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group.
Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.
연구 개요
상세 설명
Specific Aims:
- To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline evaluation and to a waitlist control group.
- To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
- To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
- To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.
연구 유형
중재적
등록 (실제)
108
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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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Brigham and Women's Hospital
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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
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male and female military veterans and active duty military personnel aged 18 and older
- A DSM IV diagnosis of post-traumatic stress disorder
- Potential subjects on medications are eligible to participate in the study
- Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
- Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process
Exclusion Criteria:
- Potential subjects are ineligible if pregnant and in their third trimester.
- Potential subjects are ineligible if they are confined to a wheel chair.
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 요가 트리트먼트
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The 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions.
In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home.
다른 이름들:
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간섭 없음: Waitlist
Waitlist control, no active treatment, treatment as usual, active treatment offered after waitlist control period.
This study began as a single arm treatment trial and then transitioned to a randomized controlled trial.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Clinician Administered PTSD Scale (CAPS)
기간: pre-intervention and 10 weeks
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pre-intervention and 10 weeks
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2차 결과 측정
결과 측정 |
기간 |
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PTSD Checklist Military Version (PCL-M)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Impact of Events Scale - Revised (IES-R)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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25-item Resilience Scale (RS)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Twenty-four-hour urinary samples
기간: pre-intervention and 3 months post intervention
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pre-intervention and 3 months post intervention
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10-minute segment of a seated 30-minute electrocardiogram recording session
기간: pre-intervention and 3 months post intervention
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pre-intervention and 3 months post intervention
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Beck Depression Inventory (BDI)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Spielberger State Trait Anxiety Inventory (STAI)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Daily Sleep Wake Diaries
기간: during intervention (weeks 1-10) and 3 months post intervention
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during intervention (weeks 1-10) and 3 months post intervention
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Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Credibility Expectancy Questionnaire (CEQ)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Body-Oriented State Questionnaire (BOSC)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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5-Facet Mindfulness Questionnaire (FFMQ)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Perceived Stress Scale (PSS)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Yoga Follow-up Questionnaire
기간: 3 months post intervention
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3 months post intervention
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PTSD Checklist Civilian Version (PCL-C)
기간: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sat Bir S Khalsa, Ph.D., Brigham and Women's Hospital
- 연구 책임자: Jennifer Johnston, MA, LMHC, Northeastern University
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
- Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
- van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.
- van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J. Disorders of extreme stress: The empirical foundation of a complex adaptation to trauma. J Trauma Stress. 2005 Oct;18(5):389-99. doi: 10.1002/jts.20047.
- Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med. 2001 Oct;31(7):1237-47. doi: 10.1017/s0033291701004287.
- Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.
- Morse DR, Cohen L, Furst ML, Martin JS. A physiological evaluation of the yoga concept of respiratory control of autonomic nervous system activity. Int J Psychosom. 1984;31(1):3-19. No abstract available.
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
2009년 8월 1일
기본 완료 (실제)
2012년 5월 1일
연구 완료 (실제)
2012년 5월 1일
연구 등록 날짜
최초 제출
2009년 8월 13일
QC 기준을 충족하는 최초 제출
2009년 8월 18일
처음 게시됨 (추정)
2009년 8월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 3월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 3월 19일
마지막으로 확인됨
2013년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2009-P-000717
- 08144033
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. .