Mindful Yoga Therapy as an Adjunctive Treatment for Veterans With PTSD and Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Posttraumatic Stress Disorder Checklist - Military Version (PCL-M)
研究概览
简要总结
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for Posttraumatic Stress Disorder (PTSD) and chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore anxiety sensitivity as a mechanism of therapeutic action.
详细描述
PTSD is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. Although several treatments are successful in treating Veterans with PTSD, many Veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. Yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive, and anxiety disorders in civilian samples, and chronic pain in Veterans. Yoga is widely offered in Veterans Affairs (VA) PTSD Treatment Programs, yet there is a lack of research on its efficacy for PTSD in Veterans.
Mindful Yoga Therapy (MYT) is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for Veterans with PTSD. This pilot clinical trial will examine the efficacy of MYT with baseline, 12 week, and 24 week follow-up assessments that will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to the study purpose.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OIF/OEF/OND Veteran
- •Ages 18-45
- •A willingness to participate in yoga and ability to commit to two 75-minute sessions per week for 12 weeks.
- •Currently enrolled (under active care) at the PTSD firm or the MST group at VACHS, West Haven
- •Participants will meet clinical criteria of PTSD (DSM-IV-TR)
- •Comorbid conditions, including substance abuse/dependence will be allowed except as noted under
排除标准
- •Veteran with combat exposure or military sexual trauma during deployment(s).
- •Non-cancer pain score (NRS pain score > 4 on a 0-10 scale whereby 0=no pain and 10=worst pain imaginable) and presence of pain for >3 consecutive months
- •Exclusion Criteria:
- •Any diagnosis of current comorbid psychotic disorders or bipolar disorder
- •Active SI/HI
- •Primary and only pain complaint as headache disorder
- •A regular yoga or meditation practice in past month (more than twice weekly)
- •Participants with significant limitations or injuries (Potential participants with significant limitations or injuries will be evaluated on an individual basis by research team and the yoga therapists.)
- •Inability to speak or read English
结局指标
主要结局
Posttraumatic Stress Disorder Checklist - Military Version (PCL-M)
时间窗: 24 weeks
A 17-item self- report measure of PTSD symptoms.
Numeric Rating Scale of Pain Intensity (NRS-I)
时间窗: 24 weeks
Global pain intensity will be assessed using the NRS-I, an 11-point numeric rating scale where a score of "0" represents no pain and a score of "10" represents the worst pain imaginable. Participants will be asked to rate their average current pain (e.g. today's pain) along with their average pain over the past week.
次要结局
- West Haven Yale Multidimensional Pain Inventory - Interference Scale (WHYMPI-I)(24 weeks)
- Mindful Yoga Therapy Evaluation of Treatment Questionnaire(24 weeks)
- Pain Treatment Credibility Questionnaire(24 weeks)
- Pain Treatment Satisfaction Questionnaire(24 weeks)
- Beck Depression Inventory (BDI)(24 Weeks)
- State-Trait Anxiety Inventory (STAI)(24 weeks)
- Difficulties in Emotion Regulation Scale (DERS)(24 weeks)
- Military Sexual Trauma(24 weeks)
- State-Trait Anger Scale (STAS)(24 weeks)
- Quality of Life (QOL)(24 Weeks)
- Pain Catastrophizing Scale (PCS)(24 weeks)
- Kentucky Inventory of Mindfulness Skills (KIMS)(24 weeks)
- Anxiety Sensitivity Index (ASI)(24 weeks)