ABSTRACT
BACKGROUND: Post-traumatic stress disorder (PTSD) remains a significant treatment challenge among Canadian veterans. Currently accessible pharmacological and non-pharmacological interventions for PTSD often do not lead to resolution of PTSD as a categorical diagnosis and have significant non-response rates. Sudarshan Kriya Yoga (SKY), a complementary and integrative health (CIH) intervention, can improve symptoms of PTSD. In response to the COVID-19 pandemic, this intervention has pivoted to virtual delivery and may be reaching new sets of participants who face multiple barriers to care. OBJECTIVE: To evaluate the implementation and effectiveness of virtually delivered Sudarshan Kriya Yoga (SKY) on decreasing PTSD symptom severity, symptoms of depression, anxiety, and pain, and improving quality of life in Canadian veterans affected by PTSD. METHODS AND ANALYSIS: Using a mixed-methods approach guided by the RE-AIM framework, we will conduct a hybrid type II effectiveness and implementation study of virtually delivered Sudarshan Kriya Yoga (SKY) for Canadian veterans. Effectiveness will be evaluated by comparing virtually delivered SKY to a waitlist control in a single-blinded (investigator and data analyst) randomized controlled trial (RCT). Change in PTSD symptoms (PCL-5) is the primary outcome and quality of life (SF-36), symptoms of depression (PHQ-9), anxiety (GAD-7), and pain (BPI) are secondary outcomes. The SKY intervention will be conducted over a 6-week period with assessments at baseline, 6-weeks, 12-weeks, and 30 weeks. The reach, effectiveness, adoption, implementation, and maintenance of the intervention will be evaluated through one-on-one semi-structured interviews with RCT participants, SKY instructors, health professionals, and administrators that work with veterans. DISCUSSION: This is the first investigation of the virtual delivery of SKY for PTSD in veterans and aims to determine if the intervention is effective and implementable at scale.