Back on My Feet: Emotional Recovery From Fall Injury
調査の概要
状態
詳細な説明
Fall accidents can be frightening experiences that cause life-changing injuries. Each year, millions of older Americans who fall may develop disabling anxiety and related distress, functional limitations, and poor health.
Our previous study adapted a well-researched anxiety treatment, Exposure-based Cognitive Behavioral Therapy (ET), for older adults diagnosed with full posttraumatic stress disorder (PTSD), subsyndromal PTSD, or fear of falling after fall injury. The approach was well-accepted by subjects and they reported both reductions in anxiety and having more fully returned to normal living immediately after the treatment and then three months later.
The purpose of this pilot study is to compare ET to another active treatment, Relaxation Training (RT). Both study treatments will consist of eight home-based sessions. ET consists of education about anxiety, relaxation training, managing distressing thoughts, healthy routine, and confronting avoided memories and situations. RT consists of techniques to ease bodily tension.
Twenty-four subjects will be randomly assigned to one of the two treatment groups. The study will compare how subjects in each group improve on outcomes such as diagnosis, anxiety severity, and quality of life over the course of treatment, and at three- and six-month follow-up.
The findings will provide the basis for larger future studies.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10065
- Weill Cornell Medical College
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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:
- Age 60 years and older
- Fall accident requiring emergency room or inpatient hospital medical care with return home within past nine months
- Community dwelling
- Able to ambulate independently or with an assistive device
- English-speaking
- Diagnosis of PTSD, subsyndromal PTSD, or Fear of Falling (determined by interview)
Exclusion Criteria:
- Cognitive impairment
- Serious or terminal illness
- Aphasia
- Current substance abuse
- Lifetime history of psychotic disorder and/or bipolar disorder
- Active suicidal or homicidal ideation
- Prescription psychotropic medication begun < 6 weeks
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Exposure-based Cognitive Behavioral Therapy (ET)
Participants will receive exposure-based cognitive behavioral therapy
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Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of exposure-based cognitive behavioral therapy, a time-limited treatment that focuses on confronting avoided memories and situations and identifying and managing distressing thoughts.
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アクティブコンパレータ：Relaxation Training (RT)
Participants will receive relaxation training
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Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of Relaxation Training, that focus on muscle relaxation and diaphragmatic breathing to address the physical symptoms of anxiety.
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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 |
|---|---|
|
Change from baseline clinician-rated PTSD at 6 weeks
時間枠：Baseline, Week 6
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Baseline, Week 6
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from baseline fear of falling at 6 weeks
時間枠：Baseline, Week 6
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Baseline, Week 6
|
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Change from baseline depression at 6 weeks
時間枠：Baseline, Week 6
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Baseline, Week 6
|
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Change from baseline anxiety at 6 weeks
時間枠：Baseline, Week 6
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Baseline, Week 6
|
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Change from baseline self-reported PTSD at 6 weeks
時間枠：Baseline, Week 6
|
Baseline, Week 6
|
協力者と研究者
捜査官
- 主任研究者：Nimali Jayasinghe, PhD、Weill Medical College of Cornell University
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 1306014003
- K23MH090244 (米国 NIH グラント/契約)
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。
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