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2023 HSR&D/QUERI National Conference Abstract

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1002 — Trauma-Sensitive Yoga versus Cognitive Processing Therapy for Women Veterans with PTSD related to MST: Final Results from a 5-year RCT

Lead/Presenter: Ursula Kelly,  Atlanta VAHCS
All Authors: Kelly UA (Atlanta VAHCS; Emory University Nell Hodgson Woodruff School of Nursing), Zaccari, BA (VA Portland Health Care System; Oregon Health & Science University, Department of Psychiatry) Loftis, JM (VA Portland Health Care System; Oregon Health & Science University, Department of Psychiatry) Higgins, M (Emory University Nell Hodgson Woodruff School of Nursing)

Objectives:
To evaluate the effectiveness of Trauma Center Trauma Sensitive Yoga (TCTSY) compared to cognitive processing therapy (CPT) to treat PTSD in women Veterans with PTSD related to military sexual trauma (MST).

Methods:
In this randomized controlled trial (RCT), 200 VA-using women Veterans from the Atlanta (n = 152) and Portland (n = 48) VAHCS’s out-patient clinics, i.e. PTSD, Mental Health, Primary Care, and others, consented to participate. Participants were randomized to TCTSY or CPT, which were provided in group format using published protocols. TCTSY consisted of ten 40-60 minute weekly sessions; CPT was provided in 12 90-minute weekly sessions. Data were collected at baseline, mid-intervention, 2-weeks post-intervention and 3-months post-intervention. Measures included the PTSD Symptom Checklist (PCL-5) and the Clinician Administered PTSD Scale for DSM-V (CAPS-5). Primary data analyses used an intent to treat (ITT) approach (n = 131) in which multilevel mixed models were used to analyze the differences between the groups over time on outcome variables. Additional analyses were performed for participants who completed the interventions with an adequate dose per protocol (PP; n = 74) to determine the impact of intervention completion and dose on the primary analyses. Finally, based on the results of the ITT and PP analyses, we conducted equivalence tests of means between TCTSY and CPT using two one-sided unequal-variance t-tests (TOST).

Results:
The majority were of the ITT sample African American/Black (72.5%) with a mean age of 48.2 years. TCTSY had a 42.6% higher treatment completion rate (65.3%) than CPT (45.8%), a significant difference, ?2(1) = 5.024, p = .025. For both CAPS-5 and PCL-5, both treatment groups improved significantly over time (p < .05 for time effects) for both ITT and PP analyses with large within group effect sizes (e.g. CAPS-5 ITT: TCTSY 0.90-0.93 and CPT 0.64-1.21). None of the group effects nor group-by-time effects were statistically significant. All effect sizes for between group differences were small (Cohen’s d < 0.37), indicating similar results in both groups. In the equivalence analyses (TOST), none of the change scores were statistically significantly different between the TCTSY and CPT groups and all of the TOST intervals fell within the equivalence bounds of +/-10 for CAPS-5 and PCL-5 for every follow-up time point except for the PCL-5 changes from baseline to 3 months post-intervention which fell slightly outside the equivalence bounds.

Implications:
TCTSY had demonstrated effectiveness in treating PTSD with equivalent effectiveness to CPT in women Veterans with MST-related PTSD. The notably higher treatment completion rate in TCTSY indicates higher treatment acceptability, overcoming a significant barrier in current first-line trauma-focused psychotherapies. Additional research is needed to 1) establish effective implementation strategies for TCTSY, 2) include patient preferences in clinical trials, 3) expand beyond MST as the PTSD index trauma, and 4) include men with sexual trauma-related PTSD.

Impacts:
TCTSY is a scalable PTSD intervention with high impact potential if implemented nationwide in the VA. Expanding PTSD treatment options beyond psychotherapy to include TCTSY, a CIH modality, would address current Veteran treatment preferences and likely increase PTSD treatment initiation, engagement, completion, and therefore increase the number of Veterans who receive effective PTSD treatment.