Objective: To conduct an interim analysis of data collected from an ongoing multisite randomized clinical trial (RCT) assessing the effectiveness of Trauma Center Trauma-Sensitive Yoga (TCTSY) for post-traumatic stress disorder (PTSD) among women veterans with PTSD related to military sexual trauma (MST). The purpose of the interim analysis was to assess outcomes from the primary site, which is geographically, demographically, culturally, and procedurally distinct from the second site. Design: RCT was conducted within a Veterans Administration Health Care System. Data collection included preintervention through 3 months postintervention. Participants: Enrollment for the main site was 152 women. The sample size for the intent-to-treat analysis was 104. The majority were African American (91.3%) with a mean age of 48.46 years. Intervention: The TCTSY intervention (n = 58) was conducted by TCTSY-certified yoga facilitators and consisted of 10 weekly 60-min group sessions. The control intervention, cognitive processing therapy (CPT; n = 46), consisted of 12 90-min weekly group sessions conducted per Veterans Administration protocol by clinicians in the PTSD Clinic. Outcome measures: The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) was used to assess current PTSD diagnosis and symptom severity, including overall PTSD and four symptom clusters. The PTSD checklist for DSM-5 (PCL-5) was used to obtain self-report of PTSD symptom severity, including total score and four symptom clusters. Results: The findings reported here are interim results from one clinical site. For both the CAPS-5 and PCL-5, total scores and all four criterion scores decreased significantly (p < 0.01) over time in all five multilevel linear models within both TCTSY and CPT groups, without significant differences between groups. There were clinically meaningful improvements seen for both TCTSY and CPT with 51.1%-64.3% of TCTSY subjects and 43.5%-73.7% of CPT decreasing their CAPS-5 scores by 10 points or more. Effect sizes for total symptom severity were large for TCTSY (Cohen's d = 1.10-1.18) and CPT (Cohen's d = 0.90-1.40). Intervention completion was higher in TCTSY (60.3%) than in CPT (34.8%). Symptom improvement occurred earlier for TCTSY (midintervention) than for CPT (2 weeks postintervention). Safety: There were no unanticipated adverse events in this study. Conclusion: The results of this study demonstrate that TCTSY may be an effective treatment for PTSD that yields symptom improvement more quickly, has higher retention than CPT, and has a sustained effect. TCTSY may be an effective alternative to trauma-focused therapy for women veterans with PTSD related to MST. The study is registered in ClinicalTrials.gov (CTR no.: NCT02640690).
Keywords: post-traumatic stress disorder; psychotherapy; sexual violence; veterans; women; yoga.