Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma

Conditions
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Stress Disorders, Post-traumatic

Intervention / Treatment
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* Behavioral: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)
* Behavioral: Cognitive Processing Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Veterans who experienced MST Diagnosed with PTSD related to MST Insomnia Willing to participate in either TCTSY or CPT study intervention Exclusion Criteria: 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 Dementia 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trauma Center Trauma-Sensitive Yoga (TCTSY)<br>10-weekly 1-hour TCTSY Sessions | Behavioral: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)<br>* (10) 1-hour sessions of trauma sensitive yoga<br>|
| Active Comparator: Cognitive Processing Therapy (CPT)<br>12-weekly 1.5 hour CPT Sessions | Behavioral: Cognitive Processing Therapy<br>* (12) 1.5 hour sessions of cognitive processing therapy<br>* Other names: Cognitive Processing Therapy-Cognitive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effectiveness of TSY compared to CPT over time in reducing PTSD symptoms, chronic pain, and insomnia | Participants in the TSY group will show statistically and clinically meaningful reductions in PTSD symptoms, chronic pain and insomnia, Clinician Administered PTSD Scale (CAPS) scores, PTSD Checklist-5 (PCL-5) scores, Brief Pain Inventory (BPI) scores, Pittsburgh Sleep Quality Index (PSQI) scores) compared to CPT group results following treatment. | Baseline; Mid-Treatment (TSY, 5 weeks: CPT, 6 weeks); 2-Weeks Post-Treatment; 3-Months Post-Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of TSY as compared to CPT over time in improving quality of life and social functioning in women Veterans with PTSD related to MST. | Participants in the TSY group will show statistically and clinically meaningful improvements in quality of life and social functioning (PROMIS measures) compared to CPT group results. - PROMIS v2.0 (Short Forms 4a) Ability to Participate in Social Roles and Activities, Social Isolation, Satisfaction with Social Roles and Activities, and Emotional Support; VR12/SF12. | Baseline; Mid-Treatment (TSY, 5 weeks: CPT, 6 weeks); 2-Weeks Post-Treatment; 3-Months Post-Treatment | 
| To evaluate the effectiveness of TSY as compared to CPT over time in alterations in C-reactive proteins. | Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (C-reactive protein). Alterations in C-reactive protein is associated with symptoms that commonly co-occur with PTSD, including depressive symptoms, fatigue, chronic tissue inflammation, and enhanced sensitivity to pain. -Blood samples will collected and analyzed by a laboratory. | Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment | 
| To evaluate the effectiveness of TSY as compared to CPT over time in elevations in pro-inflammatory cytokines. | Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (inflammatory cytokines). Elevations in pro-inflammatory cytokines, including IL-6 and IL-10, have been shown to correlate with increasing pain intensity in patients with chronic pain, psychological stress, and PTSD. IL-6 has been shown to act as a messenger relaying chemotactic peripheral immune signals to the central nervous system. In addition, IL-6 has been established as part of the biochemical sleep regulatory process. -Blood samples will collected and analyzed by a laboratory. | Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment | 
| To evaluate the effectiveness of TSY as compared to CPT over time in parasympathetic and sympathetic nervous systems | Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (nervous system). Heart rate variability reflects the central nervous system's ability to respond immediately to fluctuations in blood pressure occurring with each beat. Decreased heart rate variability has been correlated with morbidity and mortality from diverse diseases, including anxiety and depression and cardiovascular disease. - Electrocardiographic monitoring of the R-R interval using portable recording device. | Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment | 
| To evaluate the effectiveness of TSY as compared to CPT over time in autonomic electrocardiogram markers (QT interval). | Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (autonomic ECG markers). - 12-lead electrocardiogram | Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment | 
| To evaluate the effectiveness of TSY as compared to CPT over time in levels of fear and anxiety. | Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (acoustic startle response). - BIOPAC MP150 Psychophysiological Recording System Dark-enhanced startle is an ecologically valid psychophysiological paradigm for assessing contextual levels of fear and anxiety. Dark-enhanced startle is a laboratory analogue of sustained anxiety and represents a clinically useful tool for assessing anxiety-like behaviors and hyperarousal as they relate to symptom severity. | Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Disorders, Post-traumatic, Yoga, Cognitive Therapy, Chronic Pain, Veterans, cytokines, acoustic startle reflex, women, heart rate variability, sexual trauma