Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder (EYIPTSD)
2013年3月19日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
108
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Brigham and Women's Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：ヨガトリートメント
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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.
他の名前：
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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Clinician Administered PTSD Scale (CAPS)
時間枠：pre-intervention and 10 weeks
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pre-intervention and 10 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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PTSD Checklist Military Version (PCL-M)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：3 months post intervention
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3 months post intervention
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PTSD Checklist Civilian Version (PCL-C)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Sat Bir S Khalsa, Ph.D.、Brigham and Women's Hospital
- スタディディレクター：Jennifer Johnston, MA, LMHC、Northeastern University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年8月1日
一次修了 (実際)
2012年5月1日
研究の完了 (実際)
2012年5月1日
試験登録日
最初に提出
2009年8月13日
QC基準を満たした最初の提出物
2009年8月18日
最初の投稿 (見積もり)
2009年8月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年3月20日
QC基準を満たした最後の更新が送信されました
2013年3月19日
最終確認日
2013年3月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2009-P-000717
- 08144033
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。