PSL II: Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Note: Recruitment has been suspended because of COVID related restrictions and limitations imposed on data collection
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-Cognitive, 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 four 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 who report chronic pain and insomnia are being recruited from the Atlanta VAMC Trauma Recovery Program Women's Trauma Program. Participants (n=210) will be randomly assigned to trauma-sensitive yoga (10 weekly sessions) or Cognitive Processing Therapy-Cognitive (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, dark-enhanced startle, and heart rate variability. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Trauma-Sensitive Yoga (TSY) Intervention 10-weekly 1-hour TSY Sessions |
Behavioral: Trauma Sensitive Yoga Intervention
(10) 1-hour sessions of trauma sensitive yoga
|
| Active Comparator: Cognitive Processing Therapy-Cognitive Intervention (CPT-C) 12-weekly 1.5 hour CPT-C Sessions |
Behavioral: Cognitive Processing Therapy-Cognitive Only
(12) 1.5 hour sessions of cognitive processing therapy
|
Outcome Measures
Primary Outcome Measures
- Determine the effectiveness of TSY compared to CPT-C over time in reducing PTSD symptoms, chronic pain, and insomnia [Baseline; Mid-Treatment (TSY, 5 weeks: CPT, 6 weeks); 2-Weeks Post-Treatment; 3-Months Post-Treatment]
Participants in the TSY group will show statistically and clinically meaningful reductions in PTSD symptoms, chronic pain and insomnia (PTSD Checklist-5 (PCL-5) scores, Clinician Administered PTSD Scale (CAPS) scores, Pain Outcomes Questionnaire (POQ) scores, Pittsburgh Sleep Quality Index (PSQI) scores) compared to CPT-C group results following treatment.
Secondary Outcome Measures
- To evaluate the effectiveness of TSY as compared to CPT-C over time in alterations in C-reactive proteins. [Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment]
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.
- To evaluate the effectiveness of TSY as compared to CPT-C over time in parasympathetic and sympathetic nervous systems [Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment]
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.
- To evaluate the effectiveness of TSY as compared to CPT-C over time in levels of fear and anxiety. [Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment]
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.
- To evaluate the effectiveness of TSY as compared to CPT-C over time in autonomic electrocardiogram markers (QT interval). [Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment]
Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (autonomic ECG markers). - 12-lead electrocardiogram
- To evaluate the effectiveness of TSY as compared to CPT-C over time in improving quality of life and social functioning in women Veterans with PTSD related to MST. [Baseline; Mid-Treatment (TSY, 5 weeks: CPT, 6 weeks); 2-Weeks Post-Treatment; 3-Months Post-Treatment]
Participants in the TSY group will show statistically and clinically meaningful improvements in quality of life and social functioning (PROMIS measures) compared to CPT-C 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.
- To evaluate the effectiveness of TSY as compared to CPT-C over time in elevations in pro-inflammatory cytokines. [Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment]
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, (IL-1 , IL-2, IL-6, TNF- ) 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women Veterans who experienced MST
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Diagnosed with PTSD related to MST
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Insomnia
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Willing to participate in either TC-TSY or CPT-C study intervention
Exclusion Criteria:
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Schizophrenia with significant psychotic symptoms
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Current, active suicidal intent or plan
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Current substance abuse or dependence
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Certain medical conditions that can contribute significantly to psychiatric symptoms, including:
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poorly controlled hypo/hyperthyroidism
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kidney or liver failure
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Dementia
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Moderate or severe traumatic brain injury (TBI) or other cognitive impairment sufficient to interfere with ability to give informed consent
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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
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Receiving mental health treatment outside of the VA
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Ongoing participation in mental health treatment at odds with study intervention (For Example: yoga, trauma-focused treatment)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | United States | 30033 |
| 2 | VA Portland Health Care System, Portland, OR | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Ursula Ann Kelly, PhD MSN BA, Atlanta VA Medical and Rehab Center, Decatur, GA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NRI 15-151