PT  - JOURNAL ARTICLE
AU  - Peter J Bayley
AU  - R Jay Schulz-Heik
AU  - Julia S Tang
AU  - Danielle C Mathersul
AU  - Tim Avery
AU  - Melinda Wong
AU  - Jamie M Zeitzer
AU  - Craig S Rosen
AU  - Adam S Burn
AU  - Beatriz Hernandez
AU  - Laura C Lazzeroni
AU  - Emma M Seppälä
TI  - Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans
AID  - 10.1136/bmjopen-2021-056609
DP  - 2022 Aug 01
TA  - BMJ Open
PG  - e056609
VI  - 12
IP  - 8
4099  - http://bmjopen.bmj.com/content/12/8/e056609.short
4100  - http://bmjopen.bmj.com/content/12/8/e056609.full
SO  - BMJ Open2022 Aug 01; 12
AB  - 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.Data are available upon reasonable request.