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Back on My Feet: Emotional Recovery From Fall Injury

2016年8月13日 更新者:Nimali Jayasinghe、Weill Medical College of Cornell University
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.

研究概览

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

介入性

注册 (实际的)

22

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10065
        • Weill Cornell Medical College

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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
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
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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nimali Jayasinghe, PhD、Weill Medical College of Cornell University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年12月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2013年11月22日

首先提交符合 QC 标准的

2013年11月30日

首次发布 (估计)

2013年12月3日

研究记录更新

最后更新发布 (估计)

2016年8月16日

上次提交的符合 QC 标准的更新

2016年8月13日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

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.

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