Clinical trial NCT02640690: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-traumatic
Keywords: Stress Disorders, Post-traumatic
Yoga
Cognitive Therapy
Chronic Pain
Veterans
cytokines
acoustic startle reflex
women
heart rate variability
sexual trauma
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-12-29
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention
timeFrame: 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).
measure: PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention
timeFrame: 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).
Secondary outcomes:
measure: Health-related Quality of Life: VR12, Mental Component Summary (MCS): Change in Mean MCS From Baseline to 3-month Post-intervention
timeFrame: 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).
measure: Health-related Quality of Life: VR12, Physical Component: Change in Mean Subscale Score From Baseline to 3-month Post-intervention
timeFrame: 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).
measure: BPI Pain Severity: Change in Total Severity Score From Baseline to 3-months Post-intervention
timeFrame: 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).
measure: BPI Pain Interference: Change in Total Interference Score From Baseline to 3-months Post-intervention
timeFrame: 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).
measure: Changes in C-reactive Proteins (CRP) From Baseline to 3-months Post-intervention; Within Group Changes; Primary Site Only
timeFrame: 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.
measure: Changes in IL-6 Pro-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only
timeFrame: 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.
measure: Changes in IL-10 Anti-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only
timeFrame: 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.
measure: Changes in the Beck Depression Inventory-II (BDI-II) Total Score From Baseline to 3-months Post-intervention (Within Group)
timeFrame: 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.
measure: Changes in the Difficulties in Emotion Regulation Scale (DERS) Total Score From Baseline to 3-months Post-intervention (Within Group)
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: Changes in the PROMIS v2.0 Emotional Support 4a T-score From Baseline to 3-months Post-intervention (Within Group)
timeFrame: 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.
measure: Changes in the PROMIS v2.0 Satisfaction With Social Roles and Activities 4a T-score From Baseline to 3-months Post-intervention (Within Group)
timeFrame: 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.
measure: Changes in the PROMIS v2.0 Social Isolation 4a T-score From Baseline to 3-months Post-intervention (Within Group)
timeFrame: 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.
measure: Changes in the Pittsburgh Sleep Quality Index Total Score From Baseline to 3-months Post-intervention (Within Group)
timeFrame: 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.
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Ursula A Kelly, PhD MSN BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaccari B, Loftis JM, Haywood T, Hubbard K, Clark J, Kelly UA. Synchronous Telehealth Yoga and Cognitive Processing Group Therapies for Women Veterans with Posttraumatic Stress Disorder: A Multisite Randomized Controlled Trial Adapted for COVID-19. Telemed J E Health. 2022 Mar 29:10.1089/tmj.2021.0612. doi: 10.1089/tmj.2021.0612. Online ahead of print.
citation: 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.
citation: Zaccari B, Higgins M, Haywood TN, Patel M, Emerson D, Hubbard K, Loftis JM, Kelly UA. Yoga vs Cognitive Processing Therapy for Military Sexual Trauma-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2344862. doi: 10.1001/jamanetworkopen.2023.44862.