Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans

Abstract

IntroductionPost-traumatic stress disorder (PTSD) is a debilitating, highly prevalent condition. Current clinical practice guidelines recommend trauma-focused psychotherapy (eg, cognitive processing therapy; CPT) as the first-line treatment for PTSD. However, while these treatments show clinically meaningful symptom improvement, the majority of those who begin treatment retain a diagnosis of PTSD post-treatment. Perhaps for this reason, many individuals with PTSD have sought more holistic, mind–body, complementary and integrative health (CIH) interventions. However, there remains a paucity of high-quality, active controlled efficacy studies of CIH interventions for PTSD, which precludes their formal recommendation.Methods and analysesWe present the protocol for an ongoing non-inferiority parallel group randomised controlled trial (RCT) comparing the efficacy of a breathing meditation intervention (Sudarshan Kriya Yoga [SKY]) to a recommended evidence-based psychotherapy (CPT) for PTSD among veterans. Assessors are blinded to treatment group. The primary outcome measure is the PTSD Checklist-Civilian Version and a combination of clinical, self-report, experimental and physiological outcome measures assess treatment-related changes across each of the four PTSD symptom clusters (re-experiencing, avoidance, negative cognitions or mood and hyperarousal/reactivity). Once the RCT is completed, analyses will use both an intent-to-treat (using the ‘last observation carried forward’ for missing data) and a per-protocol or ‘treatment completers’ procedure, which is the most rigorous approach to non-inferiority designs.Ethics and disseminationTo the best of our knowledge, this is this first non-inferiority RCT of SKY versus CPT for PTSD among veterans. The protocol is approved by the Stanford University Institutional Review Board. All participants provided written informed consent prior to participation. Results from this RCT will inform future studies including larger multi-site efficacy RCTs of SKY for PTSD and other mental health conditions, as well as exploration of cost-effectiveness and evaluation of implementation issues. Results will also inform evidence-based formal recommendations regarding CIH interventions for PTSD.Trial registration numberNCT02366403; Pre-results.

Effect of mindfulness meditation protocol in subjects with various psychometric characteristics at high altitude

“…Various studies have used SKY for clinical efficacies (Brown & Gerbarg, 2005; Mathersul et al, 2019); however, there are less studies describing the effect of advanced meditation.…”

Emotion Dysregulation and Heart Rate variability Improve in US Veterans Undergoing Treatment for Posttraumatic Stress Disorder: Secondary Exploratory Analyses from a Randomised Controlled Trial

“…The protocol was approved by the Stanford University Institutional Review Board and conducted in accordance with the Declaration of Helsinki. The full procedure for the RCT is described elsewhere (29,35). Participants gave informed consent to participate in the study.…”

Can Yogic Breathing Techniques Like Simha Kriya and Isha Kriya Regulate COVID-19-Related Stress?

“…In contrast to above kriyas, Sudarshan kriya (SKY), evolved by Art of Living, is well studied and has shown to reduce stress and improve autonomic nervous system, immunity and wellbeing (Sharma et al, 2003;Brown and Gerbarg, 2005;Zope and Zope, 2013;Chandra et al, 2017;Mathersul et al, 2019). SKY can improve depression and can be beneficial for Posttraumatic stress disorder (Janakiramaiah et al, 2000;Katzman et al, 2012;Seppälä et al, 2014).…”