Trauma-sensitive yoga and cognitive processing group therapies for women veterans with PTSD: A multisite randomized controlled trial adapted for COVID-19

Objective: Trauma-Sensitive Yoga shows promise as an effective alternative therapy for reducing posttraumatic stress disorder (PTSD) symptomatology The objective of this study was to improve outcomes of PTSD, mental health symptoms, and psychophysiological hyperresponsivity among women veterans with PTSD from military sexual trauma (MST) in a multisite randomized controlled trial (RCT) We hypothesized that participants in the yoga group would show improvements in PTSD symptoms and psychophysiological hyperresponsivity commensurate with those in cognitive processing therapy (CPT) Initially designed as an in-person study, substantial modifications were made to our protocol to comply with strict COVID-19 related restrictions;we present those research methodologies here Methods: Women veterans with PTSD related to MST were recruited from two VA Medical Centers We used virtual means for processes of informed consent, enrollment, data collection, and intervention facilitation Participants were randomized to 10 weekly sessions of yoga or 12 weekly sessions of CPT Encrypted email, phone, HIPAA-compliant REDCap, Zoom Video Teleconferencing, and VA Video Connect were used to accommodate in-person restrictions while maintaining confidentiality Portable electrocardiogram machines, heart rate variability monitors, and finger-prick dried blood spot collection were used in conjunction with virtual staff-assistance to guide participants through self-administered collection of psychophysiological data Data were collected at baseline, during the intervention, and at two follow-up timepoints Results: The methodological modifications made to the study processes allowed the research to proceed in a virtual format and resulted in data collection for 55 participants for both sites Other outcomes from the RCT, including changes in PTSD symptoms (primary outcome), mental health symptoms (secondary outcomes), and psychophysiological hyperresponsivity (exploratory outcomes) will be reported in the future Conclusion: The adaptations of the consent, enrollment, data collection, and group interventions for this study provide an example of research methodologies for other investigators employing virtual means for group interventional studies during COVID-19 and after