Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans

Introduction Post-traumatic stress disorder (PTSD) is a debilitating, highly prevalent condition. Current clinical practice guidelines recommend trauma-focused psychotherapy (eg, cognitive processing therapy; CPT) as the first-line treatment for PTSD. However, while these treatments show clinically meaningful symptom improvement, the majority of those who begin treatment retain a diagnosis of PTSD post-treatment. Perhaps for this reason, many individuals with PTSD have sought more holistic, mind–body, complementary and integrative health (CIH) interventions. However, there remains a paucity of high-quality, active controlled efficacy studies of CIH interventions for PTSD, which precludes their formal recommendation. Methods and analyses We present the protocol for an ongoing non-inferiority parallel group randomised controlled trial (RCT) comparing the efficacy of a breathing meditation intervention (Sudarshan Kriya Yoga [SKY]) to a recommended evidence-based psychotherapy (CPT) for PTSD among veterans. Assessors are blinded to treatment group. The primary outcome measure is the PTSD Checklist-Civilian Version and a combination of clinical, self-report, experimental and physiological outcome measures assess treatment-related changes across each of the four PTSD symptom clusters (re-experiencing, avoidance, negative cognitions or mood and hyperarousal/reactivity). Once the RCT is completed, analyses will use both an intent-to-treat (using the ‘last observation carried forward’ for missing data) and a per-protocol or ‘treatment completers’ procedure, which is the most rigorous approach to non-inferiority designs. Ethics and dissemination To the best of our knowledge, this is this first non-inferiority RCT of SKY versus CPT for PTSD among veterans. The protocol is approved by the Stanford University Institutional Review Board. All participants provided written informed consent prior to participation. Results from this RCT will inform future studies including larger multi-site efficacy RCTs of SKY for PTSD and other mental health conditions, as well as exploration of cost-effectiveness and evaluation of implementation issues. Results will also inform evidence-based formal recommendations regarding CIH interventions for PTSD

Emotion dysregulation and heart rate variability improve in US veterans undergoing treatment for posttraumatic stress disorder: Secondary exploratory analyses from a randomised controlled trial

Background Emotion regulation (ER) is a key process underlying posttraumatic stress disorder (PTSD), yet, little is known about how ER changes with PTSD treatment. Understanding these effects may shed light on treatment processes. Methods We recently completed a non-inferiority design randomised controlled trial demonstrating that a breathing-based yoga practice (Sudarshan kriya yoga; SKY) was not clinically inferior to cognitive processing therapy (CPT) across symptoms of PTSD, depression, or negative affect. Here, in secondary exploratory analyses (intent-to-treat N = 85; per protocol N = 59), we examined whether self-reported ER (Difficulties in Emotion Regulation Scale; DERS) and physiological ER (heart rate variability; HRV) improved with treatment for clinically significant PTSD symptoms among US Veterans. Results DERS-Total and all six subscales improved with small-to-moderate effect sizes (d = .24–.66) following CPT or SKY, with no differences between treatment groups. Following SKY (but not CPT), HR max–min (average difference between maximum and minimum beats per minute), LF/HF (low-to-high frequency) ratio, and normalised HF-HRV (high frequency power) improved (moved towards a healthier profile; d = .42–.55). Conclusions To our knowledge, this is the first study to demonstrate that a breathing-based yoga (SKY) improved both voluntary/intentional and automatic/physiological ER. In contrast, trauma-focused therapy (CPT) only reliably improved self-reported ER. Findings have implications for PTSD treatment and interventions for emotional disorders more broadly. Trial registration Secondary analyses of ClinicalTrials.gov NCT02366403

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

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

Self-Reported Autonomic Dysregulation in Gulf War Illness

Introduction Autonomic nervous system dysregulation is commonly observed in Gulf War illness (GWI). Using a new sample, we sought to replicate and extend findings from a previous study that found autonomic symptoms predicted physical functioning in Veterans with GWI. Materials and Methods A linear regression model was used to predict physical functioning (36-item Short Form Health Survey (SF-36); n = 73, 75% male). First, we examined the predictive value of independent variables individually in the model including: the 31-item Composite Autonomic Symptom Score (COMPASS-31) total score, body mass index (BMI), mental health burden (i.e., post-traumatic stress disorder [PTSD] and/or depression), and COMPASS-31 subscales: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor. Next, we estimated linear regression models containing the three variables (autonomic symptoms, BMI, and mental health burden) identified as predictors of physical functioning from the prior study. Results These linear regression models significantly predicted physical functioning and accounted for 15% of the variance with COMPASS-31, 36.6% of variance with COMPASS-31 and BMI, and 38.2% of variance with COMPASS-31, BMI, and mental health burden. Then, forward step-wise linear regressions were applied to explore new models including COMPASS-31 subscales. Two new models accounted for more of the variance in physical functioning: 39.3% with added gastrointestinal symptoms (β = −2.206, P = .001) and 43.4% of variance with both gastrointestinal (β = −1.592, P = .008) and secretomotor subscales (β = −1.533, P = .049). Unlike the previous study we intended to replicate, mental health burden was not a significant predictor in any of our models. Conclusions Treatments that address autonomic dysregulation should be prioritized for research and clinical recommendations for Veterans with GWI who experience chronic pain

Valued living among veterans in breath-based meditation treatment or cognitive processing therapy for posttraumatic stress disorder: Exploratory outcome of a randomized controlled trial

Background Valued living is the extent to which an individual’s behavior is consistent with what they believe is important or good. It is unknown whether many complementary and integrative treatments and psychotherapies for posttraumatic stress disorder enhance valued living, and for whom. Objectives Measure within- and between-group changes in valued living in Veterans who completed cognitive processing therapy (CPT) and sudarshan kriya yoga (SKY) for posttraumatic stress disorder (PTSD); evaluate moderators of improvement. Methods Participants with clinically significant symptoms of PTSD were assigned to CPT, a first line, evidence-based psychotherapy for PTSD or SKY, an emerging breath-based meditation with strong preliminary empirical support in a parallel-groups randomized controlled trial at a single Veterans Affairs healthcare center. The Valuing Questionnaire subscales for progress in valued living (VQ-P) and obstruction in valued living (VQ-O) were exploratory outcome measures. Assessors were blind to treatment assignment. Results 59 participants completed treatment (29 CPT, 30 SKY). Participants in the CPT group improved from baseline to end of treatment in both VQ-Progress (d=0.55, p=0.02) and VQ–Obstruction (d=-0.51, p=0.03), while the SKY group did not improve on either subscale (d=0.08, p=0.69; d=0.00, p=1.00). However, differences between treatments were not statistically significant (p=0.16, 0.11, respectively). Participants reporting less valued living and more depression symptoms at baseline reported greater improvements in valued living following treatment. Conclusion CPT may have a positive effect on valued living. Individuals lower in valued living and with more depression may derive relatively more benefit

Heart rate and heart rate variability as outcomes and longitudinal moderators of treatment for pain across follow-up in Veterans with Gulf War illness

Aims Accumulating evidence suggests Gulf War illness (GWI) is characterised by autonomic nervous system dysfunction (higher heart rate [HR], lower heart rate variability [HRV]). Yoga – an ancient mind-body practice combining mindfulness, breathwork, and physical postures – is proposed to improve autonomic dysfunction yet this remains untested in GWI. We aimed to determine (i) whether HR and HRV improve among Veterans with GWI receiving either yoga or cognitive behavioural therapy (CBT) for pain; and (ii) whether baseline autonomic functioning predicts treatment-related pain outcomes across follow-up. Main methods We present secondary analyses of 24-hour ambulatory cardiac data (mean HR, square root of the mean squared differences between successive R-R intervals [RMSSD], high frequency power [HF-HFV], and low-to-high frequency ratio [LF/HF] extracted from a 5-min window during the first hour of sleep) from our randomised controlled trial of yoga versus CBT for pain among Veterans with GWI (ClinicalTrials.gov NCT02378025; N = 75). Key findings Veterans who received CBT tended towards higher mean HR at end-of-treatment. Better autonomic function (lower mean HR, higher RMSSD/HF-HRV) at baseline predicted greater reductions in pain across follow-up, regardless of treatment group. Better baseline autonomic function (mid-range-to-high RMSSD/HF-HRV) also predicted greater pain reductions with yoga, while worse baseline autonomic function (higher mean HR, lower RMSSD/HF-HRV) predicted greater pain reductions with CBT. Significance To our knowledge, this is the first study to suggest that among Veterans with GWI, HR may increase with CBT yet remain stable with yoga. Furthermore, HR and HRV moderated pain outcome across follow-up for yoga and CBT