Back on My Feet: Emotional Recovery From Fall Injury
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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New York
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New York、New York、美国、10065
- Weill Cornell Medical College
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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:
- 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
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 |
|---|---|
|
实验性的: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.
|
|
有源比较器: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change from baseline clinician-rated PTSD at 6 weeks
大体时间:Baseline, Week 6
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Baseline, Week 6
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change from baseline fear of falling at 6 weeks
大体时间:Baseline, Week 6
|
Baseline, Week 6
|
|
Change from baseline depression at 6 weeks
大体时间:Baseline, Week 6
|
Baseline, Week 6
|
|
Change from baseline anxiety at 6 weeks
大体时间:Baseline, Week 6
|
Baseline, Week 6
|
|
Change from baseline self-reported PTSD at 6 weeks
大体时间:Baseline, Week 6
|
Baseline, Week 6
|
合作者和调查者
调查人员
- 首席研究员:Nimali Jayasinghe, PhD、Weill Medical College of Cornell 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 (估计)
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.