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临床试验/NCT02429778
NCT02429778已完成不适用

Reducing Late-Life Anxiety and Improving Functioning With Self-Directed Relaxation

Palo Alto Veterans Institute for Research2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in Anxiety Symptoms

研究概览

简要总结

The PI developed a self-directed program to treat late-life anxiety called Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE). This program consists of weekly video lessons that participants watch on digital video disc (DVD) along with weekly telephone check-ins. In BREATHE participants will learn two behavioral interventions: diaphragmatic breathing and progressive muscle relaxation (PMR). The purpose of the study is to examine whether the self-directed BREATHE program is superior to a wait list control in reducing anxiety in older adults with anxiety disorders. For those assigned to wait list control, they will be offered opportunity to participate in BREATHE treatment after 8 weeks of wait list.

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
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants have a diagnosis of an anxiety disorder, specifically, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder or Anxiety Disorder Unspecified/Other Specified).
  • Participants speak English.

排除标准

  • Diagnosis of Dementia
  • Probable presence of significant cognitive impairment according to a brief cognitive screen
  • Serious mental illness (schizophrenia, psychosis, bipolar disorder)

结局指标

主要结局

Change in Anxiety Symptoms

时间窗: Change from baseline to 8 weeks

The Geriatric Anxiety Scale (GAS) is a 30-item measure of somatic, cognitive, and affective symptoms of anxiety. The first 25 items of the measure are used to compute the total score; the last 5 items provide information about the content of worries or fears. Total scores range from 0 to 75 with higher scores indicating worse anxiety. Participants provide severity ratings for items using on a four-point Likert-type scale.

Change in Activity Engagement

时间窗: Change from baseline to 8 weeks

The Activity Card Sort contains 80 photographs that depict the performance of instrumental activities, low-physical-demand leisure activities, high-physical-demand leisure activities, and social activities. This measure will be used to assess engagement in activities. The score reported is the lifestyle-adjusted function score. It represents the percentage of activities ever completed that are perceived to be easy. Higher scores indicate greater ease of activity completion/engagement.

次要结局

  • Change in Somatic Symptoms(Change from baseline to 8 weeks)
  • Change in Depressive Symptoms(Change from baseline to 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Gould

Instructor (affiliated)

Stanford University

研究点 (2)

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