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. TRIAL REGISTRATION NUMBER: NCT02366403.

Promoting Mental Health and Psychological Thriving in University Students: A Randomized Controlled Trial of Three Well-Being Interventions.

This study aimed to address the decline in mental health on U.S. university campuses by examining the effects of three interventions. University students suffer from high levels of anxiety, depression, and suicide. Counseling centers on university campuses are struggling to meet increased demand. The cost to students and universities could be buffered by offering preventative, psychoeducational, and skill-building training programs that promote mental health and psychological thriving. To date, the research literature has not yielded systematically evaluated and recommendable preventative mental health and well-being programs for university students. In a registered, randomized controlled trial, 131 university students were either placed in a non-intervention control group (N = 47) or received training in one of three 30-hour, eight-week semester-long well-being programs: SKY Campus Happiness ("SKY"; N = 29), Foundations of Emotional Intelligence ("EI"; N = 21) or Mindfulness-Based Stress Reduction ("MBSR"; N = 34). Compared to the control group and controlling for variance of baseline measurements and multiple comparisons, SKY Campus Happiness showed the greatest impact, benefiting six outcomes: depression, stress, mental health, mindfulness, positive affect and social connectedness. EI benefited one outcome: mindfulness. The MBSR group showed no change. Delivering SKY or EI to university students may be a cost-effective and efficient way to proactively and preventatively address mental health for university students and reduce the financial strain on universities.

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. TRIAL REGISTRATION NUMBER: NCT02366403; Pre-results.

Improvements in well-being and vagal tone following a yogic breathing-based life skills workshop in young adults: Two open-trial pilot studies.

BACKGROUND: While efficacy of Sudarshan Kriya Yoga (SKY) has been demonstrated in a number of prior studies, little is known about the effects of SKY taught as part of the Your Enlightened Side (YES+) workshop designed for college students and other young adults. AIMS: This study aimed to assess the effects of YES+, a yogic breathing-based life skills workshop, on multiple measures of well-being and physiological stress response. MATERIALS AND METHODS: Two nonrandomized open-trial pilot studies were conducted with a total of 74 young adults (age 25.4 ± 6.6 years; 55% female). Study 1 collected a variety of self-report questionnaires at baseline, postworkshop, and 1-month follow-up. Study 2 collected self-report questionnaires in addition to electrocardiography with a stationary cycling challenge at baseline and 1-month follow-up. RESULTS: Study 1: Improvements in self-reported depression (P's ≤ 0.010), perceived stress (P's ≤ 0.002), life satisfaction (P's ≤ 0.002), social connectedness (P's ≤ 0.004), and gratitude (P's ≤ 0.090) were observed at postworkshop and 1-month after workshop relative to baseline. Study 2: Improvements in self-reported emotion regulation were observed at 1-month follow-up relative to baseline (P = 0.019). Positive and Negative Affect Schedule-Expanded Form positive affect increased (P = 0.021), while fatigue and sadness decreased (P's ≤ 0.005). During the stationary cycling challenge, rate to recovery of electrocardiography inter-beat interval also increased from baseline to 1-month follow-up (P = 0.077). CONCLUSIONS: These findings suggest that a life skills workshop integrating yogic breathing techniques may provide self-empowering tools for enhancing well-being in young adults. Future research is indicated to further explore these effects, particularly in regards to vagal tone and other aspects of stress physiology.

The neural correlates of social connection.

Cultivating social connection has long been a goal of psychology, philosophy, religion, and public policy. Yet the psychological and neural responses that accompany a feeling of connection to others remain unclear. In the present study, we used functional neuroimaging to shed light on the neural correlates of self- and other-focused processes during the successful self-generation of feelings of social connection. To do this, we used a trait judgment task to localize functional activation related to self-focused thought. We then examined brain responses during guided exercises designed both to encourage feeling love and connection from others (i.e., self-focused) and to generate feelings of love and connection toward others (i.e., other-focused). Our results indicated that generating feelings of social connection recruited a portion of the medial prefrontal cortex (MPFC) implicated in thinking about both the self and others. Within this larger area, we observed distinct profiles of activation within different subregions. Although rostral anterior cingulate cortex was more strongly activated by other-focused components of the task, a more dorsal portion of MPFC was comparatively more active during primarily self-focused components of the task. Somewhat surprisingly, stronger feelings of social connection were not associated with greater activation in the anterior cingulate, but rather with less activation in the dorsal region of the MPFC related to self-focused thought. These results are consistent with the possibility that reducing certain kinds of self-focused thought might yield a greater sense of social connection to and care for others.

Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study.

Given the limited success of conventional treatments for veterans with posttraumatic stress disorder (PTSD), investigations of alternative approaches are warranted. We examined the effects of a breathing-based meditation intervention, Sudarshan Kriya yoga, on PTSD outcome variables in U.S. male veterans of the Iraq or Afghanistan war. We randomly assigned 21 veterans to an active (n = 11) or waitlist control (n = 10) group. Laboratory measures of eye-blink startle and respiration rate were obtained before and after the intervention, as were self-report symptom measures; the latter were also obtained 1 month and 1 year later. The active group showed reductions in PTSD scores, d = 1.16, 95% CI [0.20, 2.04], anxiety symptoms, and respiration rate, but the control group did not. Reductions in startle correlated with reductions in hyperarousal symptoms immediately postintervention (r = .93, p < .001) and at 1-year follow-up (r = .77, p = .025). This longitudinal intervention study suggests there may be clinical utility for Sudarshan Kriya yoga for PTSD.

Pilot study of a compassion meditation intervention in chronic pain.

BACKGROUND: The emergence of anger as an important predictor of chronic pain outcomes suggests that treatments that target anger may be particularly useful within the context of chronic pain. Eastern traditions prescribe compassion cultivation to treat persistent anger. Compassion cultivation has been shown to influence emotional processing and reduce negativity bias in the contexts of emotional and physical discomfort, thus suggesting it may be beneficial as a dual treatment for pain and anger. Our objective was to conduct a pilot study of a 9-week group compassion cultivation intervention in chronic pain to examine its effect on pain severity, anger, pain acceptance and pain-related interference. We also aimed to describe observer ratings provided by patients' significant others and secondary effects of the intervention. METHODS: Pilot clinical trial with repeated measures design that included a within-subjects wait-list control period. Twelve chronic pain patients completed the intervention (F= 10). Data were collected from patients at enrollment, treatment baseline and post-treatment; participant significant others contributed data at the enrollment and post-treatment time points. RESULTS: In this predominantly female sample, patients had significantly reduced pain severity and anger and increased pain acceptance at post-treatment compared to treatment baseline. Significant other qualitative data corroborated patient reports for reductions in pain severity and anger. CONCLUSIONS: Compassion meditation may be a useful adjunctive treatment for reducing pain severity and anger, and for increasing chronic pain acceptance. Patient reported reductions in anger were corroborated by their significant others. The significant other corroborations offer a novel contribution to the literature and highlight the observable emotional and behavioral changes in the patient participants that occurred following the compassion intervention. Future studies may further examine how anger reductions impact relationships with self and others within the context of chronic pain.

Loving-kindness meditation increases social connectedness.

The need for social connection is a fundamental human motive, and it is increasingly clear that feeling socially connected confers mental and physical health benefits. However, in many cultures, societal changes are leading to growing social distrust and alienation. Can feelings of social connection and positivity toward others be increased? Is it possible to self-generate these feelings? In this study, the authors used a brief loving-kindness meditation exercise to examine whether social connection could be created toward strangers in a controlled laboratory context. Compared with a closely matched control task, even just a few minutes of loving-kindness meditation increased feelings of social connection and positivity toward novel individuals on both explicit and implicit levels. These results suggest that this easily implemented technique may help to increase positive social emotions and decrease social isolation.