Back on My Feet: Emotional Recovery From Fall Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from baseline clinician-rated PTSD at 6 weeks
研究概览
简要总结
We will compare two programs that are designed to help older adults who have had fall injuries manage anxiety and improve their level of functioning. We expect that both programs will provide some benefit, but that one will promote better management.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Cognitive impairment
- •Serious or terminal illness
- •Current substance abuse
- •Lifetime history of psychotic disorder and/or bipolar disorder
- •Active suicidal or homicidal ideation
- •Prescription psychotropic medication begun < 6 weeks
结局指标
主要结局
Change from baseline clinician-rated PTSD at 6 weeks
时间窗: Baseline, Week 6
次要结局
- Change from baseline self-reported PTSD at 6 weeks(Baseline, Week 6)
- Change from baseline fear of falling at 6 weeks(Baseline, Week 6)
- Change from baseline depression at 6 weeks(Baseline, Week 6)
- Change from baseline anxiety at 6 weeks(Baseline, Week 6)
研究者
Nimali Jayasinghe
Assistant Professor of Psychology
Weill Medical College of Cornell University