Evaluation of Telehealth Interventions for Post-Trauma Stress
2011年7月28日 更新者:VA Boston Healthcare System
Evaluation of Two Telehealth Interventions Targeting Post-Trauma Stress in Combat Veterans: Comparing Mindfulness and Psychoeducation
Posttraumatic Stress Disorder (PTSD) is very prevalent within the veteran population and is associated with decreased quality of life and an increased risk of developing other psychiatric and physical illnesses.
The overarching objective of the proposed study is to evaluate the effectiveness of two telehealth treatment conditions in promoting healing within a population of veterans with full or partial PTSD.
In particular, we are targeting newly returned veterans from the Iraq and Afghanistan conflicts.
Specifically, we are comparing the relative efficacy of an alternative therapeutic approach, a Mindfulness based treatment, with a Psychoeducation treatment in reducing symptoms of PTSD and more generalized psychiatric symptoms, while increasing quality of life.
Of note, both treatment conditions will consist of two in-person sessions and six brief weekly telephone calls.
Participants will be 58 veterans (29 per condition) recruited from the VA Boston Healthcare System.
Assessment will occur before and after the delivery of the intervention.
We hypothesize that while both treatments will result in improved outcomes, the Mindfulness intervention will promote more healing than the Psychoeducation intervention.
Results from this project will help further our understanding of the role of mindfulness in treating PTSD, particularly in those veterans who are returning from deployment.
調査の概要
状態
完了
条件
詳細な説明
Aim: To evaluate the relative feasibility and healing efficacy of two eight-week telehealth interventions for individuals with combat-related PTSD: (1) Mindfulness and (2) Psychoeducation.
Objectives:
The first short-term objective is to determine whether two eight-week telehealth interventions are:
- feasible to conduct in a population of veterans with symptoms of combat-related PTSD;
- effective at promoting healing specific to combat survivors as evidenced by reductions in symptoms of PTSD;
- effective at promoting more generalized healing in combat veterans as evidenced by reductions in symptoms that are often co-morbid with PTSD (e.g., depression, anxiety, and substance abuse problem severity); and
- effective at promoting healing beyond a symptom level in combat veterans as evidenced by increases in quality of life after the interventions.
- The second short-term objective of this study is to determine whether a Mindfulness intervention will be more effective at promoting healing than a Psychoeducation intervention. This comparison will be made on the levels of specific PTSD symptoms, more general co-morbid symptoms, and global quality of life.
- The long-term objectives of this line of research are to identify mechanisms of action in a Mindfulness Telehealth Intervention that allow healing and promote increased quality of life in individuals with PTSD.
- An additional long-term objective of this project is to contribute to the development of efficacious wellness interventions that can promote healing after combat exposure in veterans returning from current military conflicts (e.g. Iraq and Afghanistan).
Hypotheses:
- It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be feasible in a population of veterans with symptoms of combat-related PTSD. Specifically, satisfaction and compliance with the interventions is predicted to be high.
- It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at promoting healing and reducing symptoms of PTSD. Specifically, it is predicted that levels of PTSD measured post-intervention will be lower than levels measured pre-intervention.
- It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at promoting healing and reducing symptoms co-morbid with PTSD. Specifically, it is predicted that levels of depression, anxiety, and substance abuse problem severity measured post-intervention will be lower than levels measured pre-intervention.
- It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at improving quality of life. Specifically, it is predicted that levels of quality of life measured post-intervention will be higher than levels measured pre-intervention.
- Although it is hypothesized that both eight-week interventions will be effective at healing for veterans with PTSD symptoms, the holistic Mindfulness intervention is hypothesized to be more effective at promoting healing and reducing symptoms of PTSD and co-morbid disorders and improving quality of life than the Psychoeducation intervention. Specifically, it is predicted that levels of PTSD, depression, anxiety, and substance abuse problem severity will be lower post-intervention and quality of life will be higher for those individuals in the Mindfulness condition than for those in the Psychoeducation condition.
研究の種類
介入
入学 (実際)
33
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
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02130
- VA Boston Healthcare System
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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:
- documented United States military service in war or peacekeeping theater
- a current diagnosis of PTSD or partial PTSD
- access to a telephone
Exclusion Criteria:
- veteran's mental status precludes completion of the assessment procedures (e.g., severe organicity or active psychosis)
- the veteran's regimen of psychiatric medication has not been stable over the past two months (if applicable)
- the veteran has symptoms consistent with a diagnosis of alcohol or drug dependence within the past three months.
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 |
|---|---|
|
実験的:Mindfulness Telehealth for PTSD
Participants receive two in-person sessions and 6 sessions over the phone.
Participants are introduced to mindfulness concepts.
CDs with guided meditation exercises are given to participants and they are asked to practice between sessions.
|
Two in-person sessions and six telephone sessions with a therapist.
Focus is on learning mindfulness skills.
|
|
アクティブコンパレータ:Psychoeducation Telehealth for PTSD
Participants receive two in-person sessions and six telehealth sessions with education about symptoms of PTSD and coping strategies.
In addition, participants are asked to read short homework assignments and think about them during the week; these are discussed in weekly sessions.
|
Two in-person sessions and six telephone sessions with a therapist.
Focus is on education about PTSD.
|
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 |
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS)
時間枠:pre and post intervention
|
Gold standard instrument to assess symptoms of PTSD.
Administered by a clinician.
|
pre and post intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PTSD Checklist
時間枠:pre and post intervention
|
Self-report instrument to assess symptoms of PTSD.
|
pre and post intervention
|
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:Barbara L Niles, Ph.D.、VA Boston Healthcare System
- 主任研究者:Amy K Silberbogen, Ph.D.、VA Boston Healthcare System
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
2007年2月1日
一次修了 (実際)
2008年4月1日
研究の完了 (実際)
2008年4月1日
試験登録日
最初に提出
2006年7月10日
QC基準を満たした最初の提出物
2006年7月10日
最初の投稿 (見積もり)
2006年7月11日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年7月29日
QC基準を満たした最後の更新が送信されました
2011年7月28日
最終確認日
2009年1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
- Telehealth for PTSD Symptoms
- SIIB 1 EA-0000043
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。