Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma (PSL II)

• ClinicalTrials.gov Identifier: NCT02640690
• Recruitment Status: Active, not recruiting
• First Posted: December 29, 2015
• Last Update Posted: July 13, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: December 16, 2015
• First Posted Date: December 29, 2015
• Last Update Posted Date: July 13, 2021
• Actual Study Start Date: January 1, 2016
• Actual Primary Completion Date: February 26, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 21, 2021)

Determine the effectiveness of TSY compared to CPT-C 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 (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.

Original Primary Outcome Measures (submitted: December 23, 2015)

• Determine the effectiveness of TSY compared to CPT-C in reducing PTSD symptoms, chronic pain, and insomnia [ Time Frame: 3 years ]
  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.
• To evaluate the effectiveness of TSY as compared to CPT-C in improving quality of life and social functioning in women Veterans with PTSD related to MST. [ Time Frame: 3 years ]
  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.
• To evaluate the effectiveness of TSY as compared to CPT-C on biological stress response and psychophysiological hyper-responsivity. [ Time Frame: 3 years ]
  Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (inflammatory cytokines, C-reactive protein levels) and psychophysiological hyper-responsivity (dark-enhanced startle measures and heart rate variability).
• PTSD Checklist-5 (PCL-5) [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]

Current Secondary Outcome Measures (submitted: April 21, 2021)

• To evaluate the effectiveness of TSY as compared to CPT-C over time in alterations in C-reactive proteins. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: 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. [ 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 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. [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: December 23, 2015)

• PROMIS v2.0 Ability to Participate in Social Roles and Activities - Short Form 4a [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• PROMIS v2.0 Social Isolation - Short Form 4a [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• PROMIS v2.0 Satisfaction with Social Roles and Activities - Short Form 4a [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• PROMIS v2.0 Emotional Support - Short Form 4a [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• Interleukin-6 (IL-6) levels from plasma [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• Interleukin-10 (IL-10) levels from plasma [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• C-Reactive Protein (CRP) levels from plasma [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• Dark-Enhanced Startle Response [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• Heart Rate Variability [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
• Dark-Enhanced Startle Response [ Time Frame: Change from Baseline to 2-Weeks Post-Treatment and 3-Months Post-Treatment ]
• Heart Rate Variability [ Time Frame: Change from Baseline to 2-Weeks Post-Treatment and 3-Months Post-Treatment ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
• Official Title: 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

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stress Disorders, Post-traumatic

Intervention

• Behavioral: Trauma Sensitive Yoga Intervention
  (10) 1-hour sessions of trauma sensitive yoga
• Behavioral: Cognitive Processing Therapy-Cognitive Only
  (12) 1.5 hour sessions of cognitive processing therapy

Study Arms

• Experimental: Trauma-Sensitive Yoga (TSY) Intervention
  10-weekly 1-hour TSY Sessions
  Intervention: Behavioral: Trauma Sensitive Yoga Intervention
• Active Comparator: Cognitive Processing Therapy-Cognitive Intervention (CPT-C)
  12-weekly 1.5 hour CPT-C Sessions
  Intervention: Behavioral: Cognitive Processing Therapy-Cognitive Only

• Publications *: Kelly U, Haywood T, Segell E, Higgins M. Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial. J Altern Complement Med. 2021 Mar;27(S1):S45-S59. doi: 10.1089/acm.2020.0417.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 23, 2015): 210
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2021
• Actual Primary Completion Date: February 26, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Women Veterans who experienced MST
• Diagnosed with PTSD related to MST
• Insomnia
• Willing to participate in either TC-TSY or CPT-C 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)

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02640690
• Other Study ID Numbers: NRI 15-151
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: VA Office of Research and Development
• Study Sponsor: VA Office of Research and Development
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ursula Ann Kelly, PhD MSN BA; Atlanta VA Medical and Rehab Center, Decatur, GA

• PRS Account: VA Office of Research and Development
• Verification Date: July 2021