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临床试验/NCT01717547
NCT01717547已完成不适用

Strength and Awareness in Action

VA Eastern Colorado Health Care System2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Change in Psychological Distress

研究概览

简要总结

The aims of this research study are to 1) assess the acceptability and feasibility of conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on Veteran's mental health.

详细描述

Since October of 2001, approximately over 2 million troops have been deployed in the Global War on Terror. Many service members are returning with both physical injuries and mental health conditions. High rates of both post traumatic stress disorder (PTSD) and/or mild traumatic brain injury (mTBI) and associated symptoms have been noted. It has been estimated that approximately 18-20% of returning service members meet criteria for PTSD and that 11-23% of veterans have a history of mTBI. It has been well established in the research literature that these two conditions frequently co-occur. While there is a dearth of evidence-based treatment for co-occurring PTSD and mTBI, it has been suggested that best practices entail treating presenting symptoms (hyperarousal, hypo-arousal, emotional reactivity, irritability, depression, anxiety, concentration problems) regardless of etiology. Yoga may be particularly well-suited to treating returning servicemen as data suggests that core symptoms that develop with a history of trauma exposure (e.g: hyperarousal; hypoarousal; emotional reactivity; anxiety, irritability), are physiologically based, somatically experienced and often not amenable to change through talking alone. In addition, yoga may assist with dysregulation often associated with mental health and physical conditions, and facilitate the development of mindfulness skills. Research suggests that that moment-to-moment awareness of present experience may decrease emotional reactivity and anxiety, and increase the capacity for self-regulation. Mindfulness skills have also been associated with: building resilience in the midst of stress; allowing one to better cope with physical discomfort; decreasing anxiety and depression; decreasing reactivity. All of these areas are relevant to improving the health and well-being of Veterans.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Veterans receiving care by a primary care provider at DVAMC
  • Between the ages of 18 and 50
  • Able to provide informed consent
  • Able to adequately answer comprehension questions
  • Documented VA primary care provider medical clearance to participate in the study as noted on the medical clearance form

排除标准

  • Veterans younger than 18, or older than 50 years of age
  • Inability to provide informed consent
  • Inability to answer comprehension questions
  • Meet criteria for active substance dependence, excluding Cannabis dependence as determined by clinical interview
  • Identification of active psychosis as determined by clinical interview
  • Documentation on the medical clearance form by VA primary care provider which suggests barriers to Veteran participation
  • Veterans whom have sustained an amputation and/or whom have limited physical mobility as documented by the VA primary care provider
  • Veterans already participating in an ongoing yoga practice of up to two times weekly

研究组 & 干预措施

Yoga

Experimental

Yoga-based treatment - manualized group treatment - classes will be held twice per week for approximately 85 minutes for a period of eight weeks.

干预措施: Yoga-based treatment (Behavioral)

结局指标

主要结局

Change in Psychological Distress

时间窗: Change from baseline to approximately 8 weeks

Change in OQ 45 Scores pre and post intervention

次要结局

  • Change in Acceptability(Change in baseline up to 8 weeks post)

研究者

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

Lisa Brenner

Director

VA Eastern Colorado Health Care System

研究点 (2)

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