Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC)
Phase 2 Randomized Controlled Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care
調査の概要
詳細な説明
The primary goals of our 3-year, 2-phase project are to develop AIM for primary care linkage and assess its feasibility and acceptability. This protocol description only pertains to Phase 2 (Randomized Controlled Trial).
42 primary care patients with primary Generalized Anxiety Disorder, Social Anxiety Disorder, and/or Panic Disorder (with or without Agoraphobia) will be randomly assigned to the AIM treatment or to a symptom tracking control group. Full assessments will occur pre- and post-treatment and 3-months follow-up. A mid-treatment assessment will include measures of cognitive biases and the primary outcome. Weekly measures of anxiety and depression will be collected, as will feedback from patients and PCPs about the research and delivery procedures.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Rhode Island
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Pawtucket、Rhode Island、アメリカ、02860
- Family Care Center at Memorial Hospital of Rhode Island
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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:
Study site patient Age ≥18 Primary diagnosis of Generalized anxiety disorder (GAD), Social Phobia (SP), and/or panic disorder with or without agoraphobia (PD/A) At least moderate anxiety severity (GAD-7 score > 10) English-speaking If on psychopharmacotherapy, stable dose for 3 months; to minimize learning effects, patients taking benzodiazepines will complete AIM prior to their first dose of the day No current psychotherapy No current severe psychiatric symptoms requiring immediate attention (e.g., imminent suicidality, psychosis)
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 |
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実験的：FaceAnxiety - Mental Habits
Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity.
Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location.
Patients will complete 256 trials per session.
Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations.
Participants will complete 150 training trials per session.
A FaceAnxiety Specialist facilitates program completion.
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Computerized treatment targeting mental habits and primary care linkage.
他の名前：
Weekly self-assessment with validated questionnaires and primary care linkage
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アクティブコンパレータ：FaceAnxiety - Symptom Tracking
Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys.
A FaceAnxiety Specialist will facilitate program completion.
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Weekly self-assessment with validated questionnaires and primary care linkage
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hamilton Anxiety Rating Scale
時間枠：6-8 weeks after first treatment session
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Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score.
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6-8 weeks after first treatment session
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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患者健康アンケート-9
時間枠：最初の治療セッションの 6 ～ 8 週間後
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最初の治療セッションの 6 ～ 8 週間後
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7-item Generalized Anxiety Disorder Scale
時間枠：6-8 weeks after first treatment session
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6-8 weeks after first treatment session
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Courtney Beard, PhD、Harvard Medical School/McLean Hospital
- 主任研究者：Risa B Weisberg, PhD、Brown 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 (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
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。