Integrative Exercise for Post-Deployment Stress
Despite the considerable efforts of the DoD and VA to improve awareness of mental health problems and access to care, many returning veterans still report substantial barriers to seeking traditional mental health care. Research suggests that a significant barrier to pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise and mindful breath training) in addressing global post-traumatic stress disorder (PTSD) symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD. Specifically, this study will examine whether a 12-week course of Integrative Exercise therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist condition) and 3) whether such treatment is feasible and acceptable.
A secondary aim of this study is to evaluate possible mechanisms underlying these effects such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic capacity, and improved sleep.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94121
- Stress and Health Research Program, University of California San Francisco
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Between the ages of 18-65 and must be physically able to participate in an exercise program
- Participants will meet criteria for either current, full syndromal PTSD of at least 3 months duration, as indexed by the Clinician Administered PTSD Scale (CAPS) diagnostic criteria or partial PTSD defined by meeting the required number of symptoms in the B symptom cluster as well as the required number of symptoms in either the C or D symptom clusters.
Exclusion Criteria:
- Lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, or mania or meet criteria for drug or alcohol dependence within the past year as assessed by the Structured Clinical Interview for DSM-IV-TR.
- Prominent suicidal or homicidal ideation
- Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months
- Pregnant, have a clinically significant neurologic disorder, systemic illness affecting CNS function, history of seizure disorder, asthma, and/or physical disabilities making it impossible to use exercise equipment will be excluded
- Myocardial infarction (MI) in the past 6 months
- Moderate to severe Traumatic Brain Injury (any history of head trauma associated with the onset of persistent cognitive complaints, neurological symptoms, or loss of consciousness > 5 minutes)
研究計画
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:Integrative Exercise
Subjects will exercise for 12 weeks (3 times weekly, with each total workout being approximately 60 minutes in length).
The exercise protocol will incorporate elements of mindfulness, cardiovascular strengthening, and controlled breathing.
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アクティブコンパレータ:Monitor Only Waitlist
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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) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
時間枠:12 weeks
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12 weeks
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Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
時間枠:12 weeks
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12 weeks
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Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only
時間枠:12 weeks
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12 weeks
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 12-09594
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。
PTSDの症状の臨床試験
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Imperial College Healthcare NHS TrustImperial College London募集
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VA Office of Research and DevelopmentUniversity of California, San Diego募集
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University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)積極的、募集していない
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Oregon Health and Science University招待による登録
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VA Office of Research and DevelopmentPortland VA Medical Center積極的、募集していない
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VA Office of Research and DevelopmentSan Diego Veterans Healthcare System完了
Integrative Exerciseの臨床試験
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University of Erlangen-Nürnberg Medical SchoolKlinikum Nürnberg完了
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Shanghai Jiao Tong University School of Medicine積極的、募集していない
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University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical... と他の協力者完了