Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 4
- 主要终点
- Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention
研究概览
简要总结
In this study, we are evaluating the effectiveness of a yoga intervention to treat posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia, and biological and physiological responses to trauma and PTSD in women Veterans who experienced military sexual trauma (MST). If effective, this yoga intervention could reduce PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic "fight or flight" stress response and the damage this stress response causes in the body, including heart disease and diabetes. This intervention could improve these women Veterans' quality of life and social functioning, for example, going to work and having satisfying relationships with family and friends. This study may support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. This new, evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines for this yoga intervention could be implemented nationally in the VA health care system.
详细描述
Objectives: The overall goal of this project is to maximize the health, social functioning, and quality of life of women Veterans with posttraumatic stress disorder (PTSD) who have experienced military sexual trauma (MST). The specific aims of this randomized controlled trial (RCT) are to evaluate the effectiveness of a trauma-sensitive yoga intervention designed specifically for women who experienced sexual trauma as compared to a gold-standard PTSD treatment, Cognitive Processing Therapy, to 1) treat PTSD and its co-morbid symptoms of chronic pain and insomnia, 2) improve social functioning and quality of life, and 3) reduce the biological and psychophysiologic responses associated with PTSD in women Veterans who experienced MST.
Research Plan: This five year RCT is the next step following the NRI Pilot Study (NRI 12-417) in which the investigators demonstrated the feasibility of recruitment, retention, randomization, intervention implementation, and data collection, including biological and psychophysiological data. Women Veterans seeking treatment for PTSD were recruited from a primary site (southeast US) and second site (northwest US) and were randomized to Trauma Center Trauma-Sensitive Yoga (TCTSY) (10 weekly sessions) or Cognitive Processing Therapy (CPT) (12 weekly sessions); both intervention protocols are data-driven. The target enrollment sample size is 210, with a target final sample of 100 or more. The investigators are conservatively allowing for 50%-60% retention, based on pilot study results.
Methods: Data Collection: Data are collected at four points, baseline through 3-months post-intervention. Outcome measures include self-report, clinical assessments and biologic and psychophysiologic markers. Specific outcomes include PTSD symptom severity, chronic pain, insomnia, social functioning, quality of life, cytokines (IL-6, IL-10), C-reactive protein, heart rate variability, and dark-enhanced startle. Data Analysis: Comparisons between the groups at baseline will be run using t-tests, Mann Whitney non-parametric tests, and chi-square tests as appropriate. Multilevel mixed models (MLM) will be used to analyze the differences between the groups over time. MLM adjusts for attrition (missing data) over time and applies appropriate correlation structure between the time points.
Clinical Relevance: Women Veterans experience MST and PTSD at alarming rates; consistently reported prevalence rates for both among VHA patient samples are 20% or more. MST and PTSD put this population at risk for significant physical and mental health symptoms, including chronic pain, suicide, and negative health behaviors. This RCT may provide sufficient evidence to support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. The positive effects of reducing distressing symptoms and PTSD-related psychophysiological stress would likely improve social functioning and quality of life and minimize the significant medical consequences of PTSD in this population. This new, evidence-based PTSD treatment could supplement existing evidence-based PTSD treatment modalities. Clinical guidelines for this innovative intervention based on evidence from this clinical trial could be disseminated to and implemented in VA Medical Centers nationwide.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women Veterans who experienced MST
- •Diagnosed with PTSD related to MST
- •Willing to participate in either TCTSY or CPT study intervention
排除标准
- •Schizophrenia with significant psychotic symptoms
- •Current, active suicidal intent or plan
- •Current substance abuse or dependence
- •Certain medical conditions that can contribute significantly to psychiatric symptoms, including:
- •poorly controlled hypo/hyperthyroidism
- •kidney or liver failure
- •Moderate or severe traumatic brain injury (TBI) or other cognitive impairment sufficient to interfere with ability to give informed consent
- •Pain due to acute injury (<3 months), post-surgical pain (<3 months) or pain due to malignancy; pain related to injury and surgery are excluded to reduce risk of exacerbating underlying injury
- •Receiving mental health treatment outside of the VA
- •Ongoing participation in mental health treatment at odds with study intervention (For Example: yoga, trauma-focused treatment)
结局指标
主要结局
Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention
时间窗: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
Clinician-Administered PTSD Scale for DSM-5 also known as CAPS-5 is the gold standard in PTSD assessment. The CAPS-5 is a structured interview that was used to assess current (past month) PTSD symptom severity. The CAPS-5 total symptom severity score is the sum of 20 items, each scored 0-4, to yield a score with a possible range of 0-80. Higher scores mean worse outcome.
PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention
时间窗: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
The PTSD Symptom-Checklist -Version 5 (PCL-5) is a 20-item, self-report instrument that assesses the presence and severity of DSM-V PTSD symptoms in the last month. It was summed for a total severity score ranging from 0-80, with higher scores representing greater symptom severity (worse outcomes). Within group changes in mean total PCL-5 score from baseline to 3-month post-intervention are reported here.
次要结局
- Health-related Quality of Life: VR12, Mental Component Summary (MCS): Change in Mean MCS From Baseline to 3-month Post-intervention(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).)
- Health-related Quality of Life: VR12, Physical Component: Change in Mean Subscale Score From Baseline to 3-month Post-intervention(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).)
- BPI Pain Severity: Change in Total Severity Score From Baseline to 3-months Post-intervention(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).)
- BPI Pain Interference: Change in Total Interference Score From Baseline to 3-months Post-intervention(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).)
- Changes in C-reactive Proteins (CRP) From Baseline to 3-months Post-intervention; Within Group Changes; Primary Site Only(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in IL-6 Pro-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in IL-10 Anti-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in the Beck Depression Inventory-II (BDI-II) Total Score From Baseline to 3-months Post-intervention (Within Group)(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in the Difficulties in Emotion Regulation Scale (DERS) Total Score From Baseline to 3-months Post-intervention (Within Group)(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in the PROMIS v2.0 Ability to Participate in Social Roles and Activities - Short Form 4a T-score From Baseline to 3-months Post-intervention (Within Group)(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in the PROMIS v2.0 Emotional Support 4a T-score From Baseline to 3-months Post-intervention (Within Group)(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in the PROMIS v2.0 Satisfaction With Social Roles and Activities 4a T-score From Baseline to 3-months Post-intervention (Within Group)(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in the PROMIS v2.0 Social Isolation 4a T-score From Baseline to 3-months Post-intervention (Within Group)(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)
- Changes in the Pittsburgh Sleep Quality Index Total Score From Baseline to 3-months Post-intervention (Within Group)(Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.)