Intervention for Anxiety After Falls
Intervention for Disabling Anxiety in Older Adults Injured by Falls
調査の概要
状態
詳細な説明
Falls are the most commonly occurring cause of traumatic injury among older adults. For many, the consequences include reduced mobility, difficulty performing basic self-care, social isolation, deteriorating health, or even death. Most interventions for falls do not address anxiety in the aftermath of falling.
After an initial study assessment, participants will complete 8 home-based sessions of a Cognitive-Behavioral therapy (CBT). The sessions will be led by a study clinician who will cover the 5 intervention components:(a) education (learning about anxiety and the rationale for treatment); (b) relaxation training (learning skills to reduce tension); (c) cognitive restructuring (learning skills needed to cope better with distressing thoughts); (d) behavioral activation (learning to initiate healthy activity); and (e) exposure (coaching in how to confront avoided thoughts, situations, and people).
Participants will also complete assessments following completion of the intervention and 3 months after completion of the intervention.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
New York
-
New York、New York、アメリカ、10065
- Weill Cornell Medical College
-
-
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 > or = 65 years
- English-speaking
- injured due to fall
- hospitalized
- returned home < or = 3 months
- ambulatory
- full or subsyndromal PTSD or Fear of Falling
- residing in one of the five boroughs of New York City
Exclusion Criteria:
- Inability to understand assessment questions
- Marked cognitive impairment
- Dementia
- Schizophrenia
- Bipolar Disorder
- Depression with psychotic features
- Delusional Disorder
- Substance Use Disorder or Dependence
- Active suicidal ideation, intent, or plan
- Active homicidal ideation, intent or plan
- Aphasia
- Acute or severe medical illness or life expectancy < 6 months
- Initiated psychotropic medications < 6 weeks prior
- Initiated mental health treatment < 6 weeks prior
- Psychosocial factors that would compromise study participation (such as not having a telephone)
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：なし
- 介入モデル：単一グループの割り当て
- 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：Cognitive Behavioral Exposure Therapy
|
Learning about anxiety
他の名前：
Learning skills to reduce tension
他の名前：
Learning skills needed to cope better with distressing thoughts
他の名前：
Learning to initiate healthy activity
他の名前：
Coaching in how to confront avoided thoughts, situations, and people)
他の名前：
|
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 |
|---|---|
|
The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.
時間枠：At initial assessment, following completion of intervention, and 3 months after completion of intervention
|
At initial assessment, following completion of intervention, and 3 months after completion of intervention
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included.
時間枠：At initial assessment, following completion of intervention, and 3 months after completion of intervention
|
At initial assessment, following completion of intervention, and 3 months after completion of intervention
|
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- K23 MH 09244
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。