Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans.
Danielle C Mathersul, Julia S Tang, R Jay Schulz-Heik, Timothy J Avery, Emma M Seppala, Peter J Bayley
BMJ Open April 3, 2019 DOI: 10.1136/bmjopen-2018-027150 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Population | Veterans with PTSD |
| Interventions | Sudarshan Kriya Yoga cognitive processing therapy |
| Topics | Breathwork PTSD Meditation |
| Keywords | Sudarshan kriya Cognitive processing therapy Non-inferiority Randomised controlled trial |
| Registration | NCT02366403 |
| Key findings | This is a protocol for a non-inferiority RCT comparing Sudarshan Kriya Yoga to cognitive processing therapy for PTSD among veterans; results are not yet reported. |
Abstract
Post-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. We 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. To 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. NCT02366403; Pre-results.
Comparable studies
Other randomized controlled trials on PTSD, most cited first.
Citations in the library
Cited by 5
- Biological mechanism study of meditation and its application in mental disorders General Psychiatry July 13, 2020
- Positive Psychological Changes at High Altitude Shown by the Low Landers after the Yoga Intervention-Sudarshan Kriya Yoga (SKY). Annals of Neurosciences 2023
- Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans. BMJ Open August 25, 2022
- Valued living among veterans in breath-based meditation treatment or cognitive processing therapy for posttraumatic stress disorder: Exploratory outcome of a randomized controlled trial Global Advances in Health and Medicine 2022
- Effect of mindfulness meditation protocol in subjects with various psychometric characteristics at high altitude Brain and Behavior May 1, 2020
Cites 12
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and 7 more in the library