Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma (PSL II)
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ClinicalTrials.gov Identifier: NCT02640690 |
Recruitment Status :
Completed
First Posted : December 29, 2015
Last Update Posted : October 14, 2022
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Tracking Information | |||||||
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First Submitted Date ICMJE | December 16, 2015 | ||||||
First Posted Date ICMJE | December 29, 2015 | ||||||
Last Update Posted Date | October 14, 2022 | ||||||
Actual Study Start Date ICMJE | January 1, 2016 | ||||||
Actual Primary Completion Date | February 26, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Determine the effectiveness of TSY compared to CPT over time in reducing PTSD symptoms, chronic pain, and insomnia [ Time Frame: 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, 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.
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma | ||||||
Official Title ICMJE | Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma | ||||||
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. | ||||||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Stress Disorders, Post-traumatic | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
200 | ||||||
Original Estimated Enrollment ICMJE |
210 | ||||||
Actual Study Completion Date ICMJE | September 30, 2021 | ||||||
Actual Primary Completion Date | February 26, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT02640690 | ||||||
Other Study ID Numbers ICMJE | NRI 15-151 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | VA Office of Research and Development | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | VA Office of Research and Development | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | VA Office of Research and Development | ||||||
Verification Date | October 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |