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

Peter J Bayley, R Jay Schulz-Heik, Julia S Tang, Danielle C Mathersul, Tim Avery, Melinda Wong, Jamie M. Zeitzer, Craig S Rosen, Adam S Burn, Beatriz Hernandez, Laura C. Lazzeroni, Emma M Seppala

BMJ Open August 25, 2022 DOI: 10.1136/bmjopen-2021-056609 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Parallel randomized controlled non-inferiority trial Peer reviewed
Sample size 85
Population Veterans with symptoms of PTSD
Interventions Sudarshan Kriya Yoga Cognitive processing therapy
Duration 6-week intervention, 1-month and 1-year follow-up
Topics Meditation PTSD
Keywords Anxiety disorders Complementary medicine Clinical trials Mental health
Registration NCT02366403
Key findings Sudarshan Kriya Yoga was non-inferior to cognitive processing therapy for reducing PTSD symptoms at 6 weeks, 1 month, and 1 year, but was inferior on depression and affect at 1 year.

Abstract

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. Outpatient Veterans Affairs healthcare centre. 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. 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. 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). 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). SKY may be non-inferior to CPT for treating symptoms of PTSD and merits further consideration as a treatment for PTSD. NCT02366403.

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Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures 2014 Randomized controlled trial n = 41
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. Military veterans and first responders aged 18 or older with chronic PTSD lasting 6... 2018 Randomized, double-blind, dose-response, phase 2 clinical trial n = 26
A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD) Patients with treatment-resistant PTSD 2012 Randomized controlled trial n = 12

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