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

A randomized non-inferiority trial compared Sudarshan Kriya Yoga (SKY), a breathing-based group program, with individual cognitive processing therapy (CPT) for post-traumatic stress disorder (PTSD) in 85 veterans (mean age 56.9, 61% white, 75 men). At 6 weeks, PTSD symptoms (measured by the PCL-C) decreased by 5.6 points with SKY and 6.8 points with CPT. The difference of -1.2 points fell within the prespecified non-inferiority margin of 10 points, indicating SKY was not inferior to CPT. SKY remained non-inferior at 1-month and 1-year follow-ups for PTSD symptoms, but was inferior to CPT on depression and affect measures at 1 year. Dropout rates were similar (27% SKY, 34% CPT). The authors suggest SKY merits further consideration as a PTSD treatment.

Study at a glance

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.