BACKGROUND/RATIONALE:
Military sexual trauma (MST) and posttraumatic stress disorder (PTSD) prevalence rates consistently reported among women Veterans receiving VA healthcare are 21%-40% and 20%, respectively. Women Veterans who experienced MST and have PTSD exhibit a variety of clinically significant symptoms, including chronic pain, insomnia, and depression. Although there are evidence-based, cognitively-oriented treatments for PTSD, not all individuals respond to or agree to participate in these; therefore, new treatments from innovative theoretical perspectives are needed. Emerging research findings suggest that yoga is an effective therapeutic intervention for the symptoms to be evaluated in this study. However, the body of research examining the beneficial effects of yoga for Veterans with PTSD is limited by methodological problems, under-representation of women, and lack of consideration of sexual trauma, though MST is the most common cause of PTSD among women Veterans. This RCT will investigate a novel approach to treating not only PTSD symptoms, but chronic pain and insomnia, which appear to be the most intractable symptoms associated with MST and PTSD. Our theoretical framework suggests that a trauma-sensitive yoga intervention will reduce PTSD symptoms, chronic pain, and insomnia via psychophysiological mechanisms, rather than the cognitive mechanisms of current psychotherapeutic treatments.

OBJECTIVE(S):
The objectives of this study are to: (a) evaluate the effectiveness of Trauma- Sensitive Yoga (TSY) compared to Cognitive Processing Therapy-Cognitive (CPT-C) in reducing PTSD symptoms, chronic pain, and insomnia in women Veterans with PTSD related to MST;
(b) 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; and (c) evaluate the effectiveness of TSY as compared to CPT-C on the biological stress response and psychophysiological hyper-responsivity.

METHODS:
We will conduct statistical analyses of data collected at five time-points (Screening/Consent, Enrollment/Randomization, Mid-Treatment, 2-Weeks Post-Treatment, and 3-Months Post-Treatment). Sources of data will include: (1) self-report measures (pain, sleep, quality of life, PTSD symptoms); (2) interview-based assessments (PTSD, depression); (3) immunological measures (inflammatory cytokines); (4) heart-rate variability; and (5) psychophysiological measures (dark-enhanced startle response). Participants will be randomly assigned to 10 sessions of TSY (Experimental Group) or 12 sessions of CPT-C (Control Group). We will be recruiting 210 women Veterans from the Atlanta VA Medical Center. To qualify, the Veteran must have PTSD related to MST, chronic pain, insomnia, and be on a stable medication regimen. Veterans will be excluded if they have schizophrenia with significant psychotic symptoms, current suicidal ideation, current substance disorder, poorly controlled medical conditions, moderate/severe TBI, and/or concurrent psychotherapy/yoga practice. 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.

FINDINGS/RESULTS:
The study team is continuing to recruit and enroll women Veterans for this PTSD treatment study. Findings are not yet available.

IMPACT:
The knowledge to be gained in this study is scientifically essential to determine the effectiveness of the experimental intervention on reducing PTSD symptoms, sleep difficulty and pain levels (Trauma-Center-Trauma Sensitive Yoga). This study has the potential to impact PTSD treatment at the national level of the VA, which is the largest health care system in the United States. This RCT could yield meaningful data to support clinical guidelines for a complementary and alternative medicine intervention which could be disseminated to and implemented in VA Medical Centers nationwide, thus improving the quality of care for female Veterans with PTSD.

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External Links for this Project

NIH Reporter

Grant Number: IK3HX001840-01
Link: https://reporter.nih.gov/project-details/8984613

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PUBLICATIONS:

Journal Articles

1. 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. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2022 Mar 29. [view]
2. 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. Journal of alternative and complementary medicine (New York, N.Y.). 2021 Mar 1; 27(S1):S45-S59. [view]
3. 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 Network Open. 2023 Dec 1; 6(12):e2344862. [view]

DRA: Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Complementary and Alternative Practices, Implementation, PTSD, Sexual Trauma/Assault
MeSH Terms: none