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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Rhode Island
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Pawtucket、Rhode Island、美国、02860
- Family Care Center at Memorial Hospital of Rhode Island
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
其他名称：
Weekly self-assessment with validated questionnaires and primary care linkage
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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Hamilton Anxiety Rating Scale
大体时间：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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次要结果测量
结果测量 |
大体时间 |
|---|---|
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患者健康问卷 9
大体时间：第一次治疗后 6-8 周
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第一次治疗后 6-8 周
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7-item Generalized Anxiety Disorder Scale
大体时间：6-8 weeks after first treatment session
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6-8 weeks after first treatment session
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合作者和调查者
调查人员
- 首席研究员：Courtney Beard, PhD、Harvard Medical School/McLean Hospital
- 首席研究员：Risa B Weisberg, PhD、Brown University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.