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:
1 War Related Illness and Injury Study Center, VA Palo Alto Health Care System, Palo Alto, California, USA Peter.Bayley@va.gov.
2 Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.
3 War Related Illness and Injury Study Center, VA Palo Alto Health Care System, Palo Alto, California, USA.
4 Psychology, Murdoch University, Murdoch, Western Australia, Australia.
5 Department of Veterans Affairs, National Center for PTSD, Menlo Park, California, USA.
6 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
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