Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
2015年4月6日 更新者：US Department of Veterans Affairs
The Effect of Acupuncture on PTSD-Related Insomnia
The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Freedom.
This study also examined the degree of veteran acceptance for a group ear acupuncture procedure.
調査の概要
状態
完了
詳細な説明
Background: Approximately 70-91% of veterans with Post-Traumatic Stress Disorder (PTSD) report insomnia.
Presently, conventional treatments for PTSD-related insomnia include medications, psychotherapy, and cognitive behavioral therapy.
While some of these conventional treatments do improve PTSD-related insomnia, many of these treatments have limitations (e.g., medication effects, lengthy time commitments, psycho-social stigma).
Because of these limitations, many veterans are increasingly turning to complementary and alternative therapies to relieve their symptoms.
There is a growing body of research that shows that acupuncture may improve many health symptoms including depression, PTSD, addiction, headaches, musculoskeletal pain, and insomnia.
However, to date, no study has specifically explored how acupuncture may affect PTSD-related insomnia.
Because so many veterans with PTSD experience PTSD-related insomnia, and because the current conflicts in Southwest Asia are producing a new generation of combat veterans, it is critical that the VA explore innovative treatments for PTSD-related health concerns.
研究の種類
介入
入学 (実際)
35
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
-
-
District of Columbia
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Washington、District of Columbia、アメリカ、20422
- Washington DC VA Medical Center, Washington, DC
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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
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
- Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria;
- Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
- Diagnosis of insomnia made after PTSD diagnosis; and
- If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.
Exclusion Criteria:
- Does not speak English;
- Not competent to sign informed consent;
- History of moderate or severe traumatic brain injury
- Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study.
- Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
- History of substance abuse Dependence (as defined per DSM IV criteria) during the one year preceding enrollment in the study OR history of illicit substance use for 3 months prior to study enrollment OR positive Audit C score at study enrollment (defined as score of 5 and above).
- Received acupuncture during past 3 months.
- On Coumadin, Heparin, or Lovenox
- Pregnancy
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：True Group Auricular Acupuncture
Received true group auricular acupuncture twice weekly for a period of two months.
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Received true group auricular acupuncture
|
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偽コンパレータ：Sham Group Auricular Acupuncture
Received sham group auricular acupuncture twice weekly for a period of two months.
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Received sham auricular acupuncture.
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他の：Wait-List Control Group
Served as wait list control.
Did not receive any acupuncture during the study period.
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Received conventional care only.
Eligible to receive true group auricular acupuncture once study period completed.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perceived Sleep Quality
時間枠：t=2 months
|
Perceived sleep quality: subjective assessment of how restorative and undisturbed sleep has been. Measured by Insomnia Severity Index (ISI) and Morin sleep diary refreshness and soundness ratings. ISI: 7-item, self-report questionnaire based on DSM-IV criteria for insomnia. ISI scores range from 0 to 28 with higher scores reflecting greater insomnia. Total scores were reported, and an ISI cutoff total score of > 8 is indicative of probable insomnia. The Morin Sleep Diary refreshness and soundness ratings are based on a 5-point Likert scale with scores ranging from 1 to 5. Scores for these two questions were reported and higher scores indicate higher perceived sleep quality. |
t=2 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
時間枠：t=2 months
|
Disruptive sleep patterns were analyzed by looking at Total Sleep Time (TST), Sleep Latency (SL), and Naps (short episodes of sleep at times other than bedtime).
Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.
|
t=2 months
|
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Hypnotic Medication Use
時間枠：t=2 months
|
Amount of sleep medication taken by study participants.
Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).
|
t=2 months
|
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Attrition Rates
時間枠：t=2 months
|
Examined attendance rates in attending group sessions to examine attrition rates.
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t=2 months
|
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Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
時間枠：t= 2 months
|
t= 2 months
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Fragmented Sleep Patterns-Sleep Efficiency
時間枠：t=2 months
|
Disruptive sleep patterns that were analyzed by looking at Sleep Efficiency(SE).
Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.
|
t=2 months
|
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：Michelle Kennedy Prisco, MSN BC-ANP、Washington DC VA Medical Center, Washington, DC
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10月1日
一次修了 (実際)
2011年9月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2009年3月23日
QC基準を満たした最初の提出物
2009年3月23日
最初の投稿 (見積もり)
2009年3月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年4月28日
QC基準を満たした最後の更新が送信されました
2015年4月6日
最終確認日
2014年9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
- NRI 08-121
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。