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临床试验/NCT03509909
NCT03509909已完成不适用

Mechanisms of Change in Yoga and Physical Activity for Veterans

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2019年5月16日最近更新:
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
117
试验地点
2
主要终点
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)

研究概览

简要总结

Posttraumatic stress disorder (PTSD) is a major health problem for the nation's Veterans, leading to significant physical and mental health morbidity and mortality. Current empirically-supported interventions ameliorate symptoms but generally do not restore full functioning, so the development of alternative or complementary approaches is a critical need. Large numbers of Veterans are seeking out yoga as a part of their recovery plans, but there is not enough evidence to recommend yoga for treatment of PTSD. Likely reflecting this heterogeneity, evidence of yoga's efficacy is highly variable. This project aims to address this problem by comparing the effect of yoga to a matched exercise control condition. The study will also explore the mechanisms by which yoga impacts PTSD. Ultimately, the goal of this research would be to contribute to integrative care planning, whereby multiple approaches can be applied in a synergistic manner to restore wellness for Veterans affected by PTSD.

详细描述

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition with a broad negative impact on physical and mental health functioning. Excellent, empirically-supported interventions for PTSD are readily available to Veterans, but the majority of patients who receive the best available treatments continue to have a diagnosable disorder after treatment. This suggests that complementary interventions may be useful to fully restore functioning. In addition, many patients seek alternatives to psychotherapy or pharmacotherapy. This is evident in the increasing numbers of individuals with PTSD are turning to alternative approaches. At present, however, the investigators lack a good evidence base from which to make recommendations about the use of complementary and alternative approaches.

Yoga is very popular practice, touted to enhance physical, mental and spiritual well-being. Many Veterans with PTSD have turned to yoga as a part of their recovery plan, often seeking care outside the specialty mental health system. Initial evidence suggests that the practice leads to clinically significant change in symptoms, but results are yet inconclusive, particularly in Veterans. Thus, this project will provide additional data as to efficacy of yoga for Veterans PTSD.

The study is a randomized controlled trial involving approximately 100 Veterans with PTSD from the San Diego area. These Veterans will be randomized to receive a manualized hatha yoga intervention or a supportive exercise control condition. Both interventions will be delivered by trained instructors via livestreaming or recorded classes over a 12-week period. Assessment of clinical outcomes and methodological variables will take place before, during, immediately after, and 3-months after the intervention. Analyses will focus on change in the intervention groups over time and the degree to which change is associated with the candidate mechanisms.

Results of this study have the potential to inform the way in which yoga is delivered to Veterans as well as to increase knowledge about the underlying processes by which PTSD can be ameliorated. Given the high demand for yoga demand by individuals with PTSD and the degree to which the practice is already being provided in many clinical settings, findings from this study will be immediately relevant. Findings may also guide future research in complementary and alternative approaches by demonstrating the principle of targeting different processes of change to create an integrative care plan.

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)

盲法说明

The outcome evaluator is blind to experimental condition

入排标准

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

入选标准

  • Veterans who have clinically meaningful PTSD symptoms

排除标准

  • serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months
  • a known, untreated substance abuse or dependence problem
  • inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem
  • serious mental disorders, such as psychotic disorders or bipolar type I, or serious dissociative symptoms
  • cognitive impairment that would interfere with treatment
  • circumstances that lead to recurrent traumatization
  • e.g., engaged in a violent relationship
  • any medical condition for which exercise is contraindicated, including pregnancy
  • concurrent enrollment in any other treatment specifically targeting PTSD symptoms or in any meditative or mind-body intervention
  • including yoga practice >1 class/month in the preceding 6 months

研究组 & 干预措施

Hatha yoga

Experimental

12- week group-based yoga class

干预措施: Hatha yoga (Behavioral)

Supportive exercise

Active Comparator

12-week group-based stretching and strengthening class

干预措施: Supportive physical activity (Behavioral)

结局指标

主要结局

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)

时间窗: Baseline to post-treatment (approx 12 weeks)

Semi-structured clinical interview assessing severity of PTSD symptoms administered by a trained, blinded assessor. The range of scores is 0-80. Mpre-Mpost is presented, so positive numbers indicate a reduction in PTSD symptom severity from before to after the intervention.

次要结局

  • Patient Health Questionnaire Depression Items (PHQ-9)(Baseline to post-treatment (approx 12 weeks))
  • State-Trait Anxiety Inventory, State Subscale(Baseline to post-treatment (approx 12 weeks))
  • State-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale(Baseline to post-treatment (approx 12 weeks))
  • Insomnia Severity Index(Baseline to post-treatment (approx 12 weeks))
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a(Baseline to post-treatment (approx 12 weeks))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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