Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans


Author: Peter J Bayley1,2, R Jay Schulz-Heik3, Julia S Tang3, Danielle C Mathersul4, Tim Avery3,5, Melinda Wong3, Jamie M Zeitzer2, Craig S Rosen2,5, Adam S Burn3, Beatriz Hernandez2, Laura C Lazzeroni2, Emma M Seppälä2,6

Affiliation: <sup>1</sup> War Related Illness and Injury Study Center, VA Palo Alto Health Care System, Palo Alto, California, USA Peter.Bayley@va.gov.

<sup>2</sup> Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.

<sup>3</sup> War Related Illness and Injury Study Center, VA Palo Alto Health Care System, Palo Alto, California, USA.

<sup>4</sup> Psychology, Murdoch University, Murdoch, Western Australia, Australia.

<sup>5</sup> Department of Veterans Affairs, National Center for PTSD, Menlo Park, California, USA.

<sup>6</sup> School of Management, Yale University, New Haven, Connecticut, USA.
Conference/Journal: BMJ Open
Date published: 2022 Aug 25
Other:
 Volume ID: 12   ,  Issue ID: 8   ,  Pages: e056609   ,  Special Notes: doi: 10.1136/bmjopen-2021-056609.   ,  Word Count: 282  
    Objective:

Test whether Sudarshan Kriya Yoga (SKY) was non-inferior to cognitive processing therapy (CPT) for treating symptoms of post-traumatic stress disorder (PTSD) among veterans via a parallel randomised controlled non-inferiority trial.



Setting:

Outpatient Veterans Affairs healthcare centre.



Participants:

85 veterans (75 men, 61% white, mean age 56.9) with symptoms of PTSD participated between October 2015 and March 2020: 59 participants completed the study.



Interventions:

SKY emphasises breathing routines and was delivered in group format in a 15-hour workshop followed by two 1-hour sessions per week for 5 weeks. CPT is an individual psychotherapy which emphasises shifting cognitive appraisals and was delivered in two 1-hour sessions per week for 6 weeks.



Measures:

The primary outcome measure was the PTSD Checklist-Civilian Version (PCL-C). The secondary measures were the Beck Depression Inventory-II (BDI-II) and Positive and Negative Affect Scale (PANAS).



Results:

Mean PCL-C at baseline was 56.5 (±12.6). Intent-to-treat analyses showed that PCL-C scores were reduced at 6 weeks (end of treatment) relative to baseline (SKY, -5.6, d=0.41, n=41: CPT, -6.8, d=0.58, n=44). The between-treatment difference in change scores was within the non-inferiority margin of 10 points (-1.2, 95% CI -5.7 to 3.3), suggesting SKY was not inferior to CPT. SKY was also non-inferior at 1-month (CPT-SKY: -2.1, 95% CI -6.9 to 2.8) and 1-year (CPT-SKY: -1.8, 95% CI -6.6 to 2.9) assessments. SKY was also non-inferior to CPT on the BDI-II and PANAS at end of treatment and 1 month, but SKY was inferior to CPT on both BDI-II and PANAS at 1 year. Dropout rates were similar (SKY, 27%, CPT, 34%: OR=1.36, 95% CI 0.51 to 3.62, p=0.54).



Conclusions:

SKY may be non-inferior to CPT for treating symptoms of PTSD and merits further consideration as a treatment for PTSD.



Trial registration number:

NCT02366403.



Keywords: Anxiety disorders; COMPLEMENTARY MEDICINE; Clinical trials; Depression & mood disorders; MENTAL HEALTH.



PMID: 36008059 DOI: 10.1136/bmjopen-2021-056609