Yoga is effective for treating chronic pain in veterans with Gulf War Illness at long-term follow-up.

BACKGROUND: Clinical Practice Guidelines for Gulf War Illness (GWI) recommend integrative health approaches such as yoga for relief from symptoms, yet little is known about the long-term efficacy of yoga in reducing symptoms of GWI. Here, we evaluated the long-term efficacy of yoga and cognitive-behavioral therapy (CBT) chronic pain treatment in a randomized controlled trial (RCT) of 75 Veterans (57 men, 42-71 ± 7.1 years of age) with Gulf War Illness (GWI). METHODS: Participants received either 10 weeks of yoga or 10 weeks of CBT for chronic pain. The primary outcome measures were pain severity, and pain interference (Brief Pain Inventory-Short Form). The secondary outcome measures were fatigue, as indicated by a measure of functional exercise capacity (6-Minute Walk Test), depression, autonomic symptom severity, and quality of life. Piecewise linear mixed models were used to examine study hypotheses. RESULTS: Compared to the CBT group, yoga was associated with greater reductions in pain severity during the 6-month follow-up period (group × time interaction: b = 0.036, se = 0.014, p = .011). Although we did not find between-group differences in the other primary or secondary outcome measures during follow-up (p's > 0.05), exploratory analyses revealed within-group improvements in pain interference, total pain (an experimental outcome variable which combines pain severity and interference), and fatigue in the yoga group (p's < 0.05) but not in the CBT group. CONCLUSIONS: This is the first study to report long-term follow-up results of yoga as a treatment for GWI. Our results suggest that yoga may offer long-term efficacy in reducing pain, which is a core symptom of GWI. TRIAL REGISTRATION: Secondary analyses of ClinicalTrials.gov NCT02378025.

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.

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.

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 .

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.govNCT02378025; 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.

Clinical yoga program utilization in a large health care system.

The U.S. Department of Veterans Affairs (VA) offers yoga for multiple conditions. Little information is available regarding how frequently yoga is utilized, by whom, or for which medical conditions. Here we describe referral patterns and patient adoption rates in a clinical yoga program, including telehealth yoga, at VA Palo Alto Health Care System (VAPAHCS). Referral and demographic data were extracted from the electronic medical records of 953 veterans (692 male, 261 female) referred to the outpatient clinical yoga program between 2010 and 2016. Attendance data were extracted from the same time plus 1 year. Referee demographics were compared to the overall VAPAHCS population. Twenty-two of the 187 referring providers accounted for half (50.4%) of referrals, predominantly from primary care and mental health clinics. Compared to the overall VAPAHCS patient population, referees were similar age and more likely to be female. Attendance was associated with age (older veterans were more likely to attend) but not gender. Those referred for mental health reasons were more likely to attend yoga compared to those referred for physical symptoms or for wellness (e.g., strength, health, mindfulness). Telehealth yoga follow through was lower but attendance rate similar to in-person yoga. These data provide an overview of referral and uptake in a large VA setting. Overall, referral was performed by a few providers in mental health and primary care clinics. The typical demographic of attendee was a White male from the Vietnam War era, reflective of the VA population. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Yoga is effective in treating symptoms of Gulf War illness: A randomized clinical trial.

Many Veterans of the 1990-1991 Gulf War report symptoms of Gulf War Illness, a condition involving numerous chronic symptoms including pain, fatigue, and mood/cognition symptoms. Little is known about this condition's etiology and treatment. This study reports outcomes from a randomized controlled single-blind trial comparing yoga to cognitive behavioral therapy for chronic pain and other symptoms of Gulf War Illness. Participants were Veterans with symptoms of GWI: chronic pain, fatigue and cognition-mood symptoms. Seventy-five Veterans were randomized to treatment via selection of envelopes from a bag (39 yoga, 36 cognitive behavioral therapy), which consisted of ten weekly group sessions. The primary outcomes of pain severity and interference (Brief Pain Inventory- Short Form) improved in the yoga condition (Cohen's d = .35, p = 0.002 and d = 0.69, p < 0.001, respectively) but not in the CBT condition (d = 0.10, p = 0.59 and d = 0.25 p = 0.23). However, the differences between groups were not statistically significant (d = 0.25, p = 0.25; d = 0.43, p = 0.076), though the difference in an a-priori-defined experimental outcome variable which combines these two variables into a total pain variable (d = 0.47, p = 0.047) was significant. Fatigue, as indicated by a measure of functional exercise capacity (6-min walk test) was reduced significantly more in the yoga group than in the CBT group (between-group d = .27, p = 0.044). Other secondary outcomes of depression, wellbeing, and self-reported autonomic nervous system symptoms did not differ between groups. No adverse events due to treatment were reported. Yoga may be an effective treatment for core Gulf War Illness symptoms of pain and fatigue, making it one of few treatments with empirical support for GWI. Results support further evaluation of yoga for treating veterans with Gulf War Illness. CLINICAL TRIAL REGISTRY: clinicaltrials.gov Registration Number NCT02378025.

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.

Tele-yoga for Chronic Pain: Current Status and Future Directions.

Pain is a pervasive, debilitating disorder that is resistant to long-term pharmacological interventions. Although psychological therapies such as cognitive behavior therapy demonstrate moderate efficacy, many individuals continue to have ongoing difficulties following treatment. There is a current trend to establish complementary and integrative health interventions for chronic pain, for which yoga has been found to have exciting potential. Nevertheless, an important consideration within the field is accessibility to adequate care. Telehealth can be used to provide real-time interactive video conferencing leading to increased access to health care for individuals located remotely or who otherwise have difficulty accessing services, perhaps through issues of mobility or proximity of adequate services. This article assesses the current status and feasibility of implementing tele-yoga for chronic pain. Methodological limitations and recommendations for future research are discussed.

Results from a clinical yoga program for veterans: yoga via telehealth provides comparable satisfaction and health improvements to in-person yoga.

BACKGROUND: Yoga is increasingly popular, though little data regarding its implementation in healthcare settings is available. Similarly, telehealth is being utilized more frequently to increase access to healthcare; however we know of no research on the acceptability or effectiveness of yoga delivered through telehealth. Therefore, we evaluated the feasibility, acceptability, and patient-reported effectiveness of a clinical yoga program at a Veterans Affairs Medical Center and assessed whether these outcomes differed between those participating in-person and those participating via telehealth. METHODS: Veterans who attended a yoga class at the VA Palo Alto Health Care System were invited to complete an anonymous program evaluation survey. RESULTS: 64 Veterans completed the survey. Participants reported high satisfaction with the classes and the instructors. More than 80% of participants who endorsed a problem with pain, energy level, depression, or anxiety reported improvement in these symptoms. Those who participated via telehealth did not differ from those who participated in-person in any measure of satisfaction, overall improvement (p = .40), or improvement in any of 16 specific health problems. CONCLUSIONS: Delivering yoga to a wide range of patients within a healthcare setting appears to be feasible and acceptable, both when delivered in-person and via telehealth. Patients in this clinical yoga program reported high levels of satisfaction and improvement in multiple problem areas. This preliminary evidence for the effectiveness of a clinical yoga program complements prior evidence for the efficacy of yoga and supports the use of yoga in healthcare settings.

Mindfulness as a Weight Loss Treatment for Veterans.

Despite substantial evidence for their effectiveness in treating disordered eating and obesity, mindfulness-based treatments have not been broadly implemented among Veterans. A number of reviews have reported mindfulness to be beneficial in promoting healthy eating behaviors and weight loss among non-Veteran samples. We discuss this approach in the context of the Veterans Affairs system, the largest integrated healthcare provider in the U.S. and in the context of Veterans, among whom obesity is at epidemic proportions. In this article, we discuss what is known about treating obesity using a mindfulness approach, mindfulness interventions for Veterans, a new pilot mindfulness-based weight loss program designed for Veterans, and future directions for this type of obesity treatment in Veterans. We conclude that this population may be uniquely poised to benefit from mindfulness-based treatments.

Quantification of adverse events associated with functional MRI scanning and with real-time fMRI-based training.

BACKGROUND: Although functional magnetic resonance imaging (fMRI) is in widespread research use, the safety of this approach has not been extensively quantitatively evaluated. Real-time fMRI (rtfMRI)-based training paradigms use fMRI neurofeedback and cognitive strategies to alter regional brain activation, and are currently being evaluated as a novel approach to treat neurological and psychiatric conditions. PURPOSE: The purpose of this study is to determine the incidence and severity of any adverse events that might be caused by changes in brain activation brought about through fMRI or through rtfMRI-based training paradigms. METHOD: Quantitative adverse event self-report data were obtained from 641 functional imaging scans in 114 chronic pain patients participating in a research clinical trial examining repeated fMRI scans and rtfMRI-based training. Participants recorded potential adverse events during non-scanning baseline, fMRI scanning, or rtfMRI-based training sessions. RESULTS: There were no significant increases in the number of reported adverse events following fMRI or rtfMRI scanning sessions compared to baseline non-scanning sessions in a chronic pain trial (N = 88). There were no reported adverse events of any kind for over 90% of sessions during the course of rtfMRI-based training. When adverse events were reported, they were almost exclusively mild or moderate in severity and similar to those observed in a non-scanning baseline session. There was no increase in adverse events reported by participants receiving feedback from any of four brain regions during repeated rtfMRI-based training scans compared to non-scanning baseline sessions. For chronic pain patients completing the rtfMRI-based training paradigm including up to a total of nine scan sessions (N = 69), neither the number nor severity of reported events increased during the fMRI or rtfMRI scanning portions of the paradigm. There were no significant increases in the number of reported adverse events in participants who withdrew from the study. CONCLUSION: Repeated fMRI scanning and rtfMRI training, consisting of repeated fMRI scanning in conjunction with cognitive strategies and real-time feedback from several regions of interest in multiple brain systems to control brain region activation, were not associated with an increase in adverse event number or severity. These results demonstrate the safety of repetitive fMRI scanning paradigms similar to those in use in many laboratories worldwide, as well as the safety rtfMRI-based training paradigms.