You are here

  • Home
  • Archive
  • Volume 9, Issue 4
  • Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans

Article Text

Article menu

Download PDFPDF

XML
Mental health
Protocol
Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans
  1. Danielle C Mathersul1,2,
  2. Julia S Tang1,
  3. R Jay Schulz-Heik1,
  4. Timothy J Avery1,2,
  5. Emma M Seppälä3,4,
  6. Peter J Bayley1,2
  1. 1 War Related Illness and Injury Study Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA
  2. 2 Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA
  3. 3 Center for Compassion and Altruism Research and Education, Stanford University School of Medicine, Stanford, California, USA
  4. 4 Yale Center for Emotional Intelligence, Yale University, New Haven, Connecticut, USA
  1. Correspondence to Dr Danielle C Mathersul; dcmathersul{at}stanford.edu

Abstract

Introduction 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.

Methods and analyses 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.

Ethics and dissemination 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.

Trial registration number NCT02366403; Pre-results.

  • post-traumatic stress disorder
  • Sudarshan Kriya
  • pranayama
  • cognitive processing therapy
  • non-inferiority
  • randomised controlled trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-027150

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors DCM was responsible for writing the manuscript with significant contributions from all the other authors. PJB is principal investigator and executive manager of this RCT. PJB and EMS conceptualized the study. JST is the study coordinator and one of the SKY instructors. DCM, RJS-H and TJA are the CPT providers. RJS-H is the supervising licensed clinical psychologist. All authors read and approved the final manuscript.

    • Funding This RCT is funded by the Department of Veterans Affairs RR&D Merit Review (1 I01 RX001485-01; PJB). DCM and TJA are supported by VA Advanced Fellowships in the War Related Illness and Injury Study Center (WRIISC), a National VA Post-Deployment Health Resource.

    • Disclaimer Funding bodies have not, and will not, participate in the study design, the collection, management, analysis or interpretation of data, nor the writing of findings for publication.

    • Competing interests None declared.

    • Ethics approval The protocol is approved by the Stanford University Institutional Review Board.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.