Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.

BACKGROUND: Interventions that promote adaptive emotion regulation (ER) skills reduce pain in patients with chronic pain; however, whether the effects of yoga practice on chronic low back pain (CLBP) are due to improvements in ER remains to be examined. OBJECTIVE: This study will test whether the effects of yoga on CLBP (improved pain severity and interference) are mediated by improved ER, the extent to which effects are related to specific aspects of ER, and the role of pain sensitization as a mediator or moderator of effects. In this study, pain sensitization will be assessed by quantitative sensory testing and gene expression profiles to examine whether pain sensitization moderates yoga's effects on pain or whether yoga and ER abilities reduce pain sensitization, leading to decreased pain severity and interference. METHODS: For this 2-arm parallel group blinded randomized controlled trial, we will enroll 204 adults with CLBP who will be randomized to receive the yoga (n=102) or a control stretching and strengthening (n=102) intervention, which are delivered via web-based synchronous biweekly 75-minute sessions over 12 weeks. Participants are encouraged to practice postures or exercises for 25 minutes on other days using accessible prerecorded practice videos that are sent to participants digitally. Participants will be assessed at 5 time points: baseline, midintervention (6 weeks), postintervention (12 weeks), and 3- and 6-month follow-ups. Assessments of ER, pain severity and interference, pain sensitivity including somatosensory and gene expression profiles, and physical strength and flexibility will be conducted at each visit. The fidelity of the interventions is assessed using a manualized checklist to evaluate recorded group sessions to ensure consistent instructor delivery. RESULTS: The primary outcome will be the mean change in pain severity as measured by the Brief Pain Inventory-Short Form at 12 weeks. The primary mechanism of action is ER measured by change in the Difficulties in Emotion Regulation Scale total score. Secondary outcomes include pain sensitivity, physical strength and flexibility, pain interference, and quality of life. A mediation path analysis and series of moderated mediation path analyses will be conducted to test the study hypotheses. As of January 2024, we have enrolled 138 participants. We expect the study to be completed by May 2025. CONCLUSIONS: The study will provide important data for evaluating whether improvements in ER are responsible for reduced pain perception and pain sensitivity as well as increased quality of life in the context of chronic pain. The study findings have important implications for determining the mechanism of action for yoga and possibly other mind-body interventions as nonpharmacological therapies for pain management. The results of the study will inform the content, delivery, and measures for intervention trials involving yoga as a modality for relieving pain and improving function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04678297; https://clinicaltrials.gov/study/NCT04678297. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56016.

Yoga Practice Among Veterans With and Without Chronic Pain: A Mixed Methods Study.

OBJECTIVES: The primary aim of this study was to examine differences in yoga practice between persons with and without chronic pain. Secondarily, we describe use of the Essential Properties of Yoga Questionnaire, Short Form (EPYQ-SF) for self-report. DESIGN: Participants were members of an existing cohort of veterans who completed a 2015-2016 survey focused on pain and nonpharmacological health practices. Cohort members who reported yoga in the past year [n=174 (9.4%) of 1850] were eligible for the present study, which used multiple-contact mixed-mode survey methodology to collect data on yoga practices. The EPYQ-SF was used to assess properties and context of yoga practice. Practice patterns were compared for participants with and without chronic pain. To explore potential reasons for reported yoga practice patterns, focused semistructured interviews were conducted with a subset of participants. RESULTS: Of 174 participants contacted, 141 (82%) returned the yoga questionnaire and 110 (78% of respondents) were still practicing yoga. Among yoga practitioners, 41 (37%) had chronic pain. Practitioners with chronic pain reported gentler (2.8 vs. 3.1, 5-point scale) and less active (2.9 vs. 3.3) yoga practice than those without. Those with chronic pain attended yoga studios less frequently and reported shorter yoga practices than those without. Most yoga practice was self-directed and at home. CONCLUSIONS: Differences in yoga practice of persons with and without chronic pain have implications for implementation of yoga interventions for chronic pain. Future interventions should focus on alternative individual delivery formats or addressing barriers to group practice among people with chronic pain.

Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.

BACKGROUND: Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP). OBJECTIVE: Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care. METHODS: Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon. RESULTS: Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was "dominant" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost. DISCUSSION/CONCLUSIONS: Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.

Associations of Coffee and Tea Consumption With Survival to Age 90 Years Among Older Women.

BACKGROUND: Coffee and tea are two of the most widely consumed beverages worldwide and have been associated with reduced risk of mortality in some studies. However, it is unknown whether consumption of these beverages is associated with survival to an advanced age. OBJECTIVE: To examine associations of coffee and tea consumption with survival to age 90 years. DESIGN: Prospective cohort study among participants from the Women's Health Initiative, recruited during 1993 to 1998 and followed up until March 31, 2018. SETTING: The setting included 40 US clinical centers. PARTICIPANTS: A racially and ethnically diverse cohort of 27,480 older women, aged 65 to 81 years at baseline. MEASUREMENTS: Women were classified as having either survived to age 90 years or died before this age. Consumption of caffeinated and decaffeinated coffee and caffeinated tea was assessed at baseline and categorized as 0, 1, 2 to 3, or 4 or more cups/day. Associations of coffee and tea consumption with survival to age 90 years were examined using logistic regression models adjusted for sociodemographic characteristics, lifestyle behaviors, dietary quality, and chronic disease history. RESULTS: A total of 14,659 (53.3%) women survived to age 90 years during follow-up. Caffeinated coffee, decaffeinated coffee, or caffeinated tea consumption was not significantly associated with survival to age 90 years after adjusting for confounders. Findings did not significantly vary by smoking, body mass index, or race/ethnicity. CONCLUSION: No amount of coffee or tea consumption was associated with late-age survival among older women. These findings may be reassuring to older women who consume coffee and tea as part of their daily diets but do not support drinking these beverages to achieve longevity.

Exploring how different types of yoga change psychological resources and emotional well-being across a single session.

OBJECTIVES: Yoga demonstrates beneficial effects in many populations, yet our understanding of how yoga brings about these effects is quite limited. Among the proposed mechanisms of yoga are increasing psychological resources (mindfulness, body consciousness, self-transcendence, spiritual peace, and social connectedness) that may bring about salutary effects on emotional wellbeing. Further, yoga is a complex practice comprising meditation, active and restorative postures, and breathwork; however little is known about how different components may affect mechanisms. We aimed to determine how an acute session of yoga (and its specific components) related to pre- to post- session changes in proposed mechanisms (psychological resources) and whether those changes were associated with positive changes in emotions. DESIGN: 144 regular yoga practitioners completed measures of mindfulness, body consciousness, self-transcendence, social connectedness, spiritual peace, and exercise-induced emotions (positive engagement, revitalization, tranquility, exhaustion) immediately before and after a yoga session (N = 11 sessions, each a different type of yoga). Perceived properties of each yoga session, exercise exertion and engagement with the yoga teacher were assessed immediately following the session. RESULTS: Pre-to post- yoga, levels of positive emotions (engagement, tranquility and revitalization) increased while exhaustion decreased. Further, all psychological resources increased and closely tracked improved emotions. Additionally, aspects of the yoga session correlated with changes in psychological resources (mechanisms) and emotions. CONCLUSIONS: Yoga may influence multiple psychological mechanisms that influence emotional well-being. Further, different types of yoga may affect different mechanisms. Results can inform yoga interventions aiming to optimize effects through specific mechanisms such as mindfulness or spirituality.

Secondary Outcomes from a Randomized Controlled Trial of Yoga for Veterans with Chronic Low-Back Pain.

Chronic low-back pain (cLBP) is a prevalent condition, and rates are higher among military veterans. cLBP is a persistent condition, and treatment options have either modest effects or a significant risk of side-effects, which has led to recent efforts to explore mind-body intervention options and reduce opioid medication use. Prior studies of yoga for cLBP in community samples, and the main results of a recent trial with military veterans, indicate that yoga can reduce back-related disability and pain intensity. Secondary outcomes from the trial of yoga with military veterans are presented here. In the study, 150 military veterans (Veterans Administration patients) with cLBP were randomized to either yoga or a delayed-treatment group receiving usual care between 2013 and 2015. Assessments occurred at baseline, 6 weeks, 12 weeks, and 6 months. Intent-to-treat analyses were conducted. Yoga classes lasting 60 minutes each were offered twice weekly for 12 weeks. Yoga sessions consisted of physical postures, movement, focused attention, and breathing techniques. Home practice guided by a manual was strongly recommended. The primary outcome measure was Roland-Morris Disability Questionnaire scores after 12 weeks. Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage. Yoga participants improved more than delayed-treatment participants on pain interference, fatigue, quality of life, and self-efficacy at 12 weeks and/or 6 months. Yoga participants had greater improvements across a number of important secondary health outcomes compared to controls. Benefits emerged despite some veterans facing challenges with attending yoga sessions in person. The findings support wider implementation of yoga programs for veterans, with attention to increasing accessibility of yoga programs in this population.

Yoga to prevent mobility limitations in older adults: feasibility of a randomized controlled trial.

BACKGROUND: The loss of mobility during aging impacts independence and leads to further disability, morbidity, and reduced life expectancy. Our objective was to examine the feasibility and safety of conducting a randomized controlled trial of yoga for older adults at risk for mobility limitations. METHODS: Sedentary older adults (n = 46; age 60-89) were recruited and randomized to either yoga or a health education comparison group. Yoga sessions (60-min) occurred 2x weekly, and 90-min health education sessions occurred weekly, for 10 weeks. The primary outcomes were recruitment rate, intervention attendance, and retention at assessments. Adverse event rates and participant satisfaction were also measured. Physical performance measures of gait, balance, and strength and self-report outcome measures were administered at baseline and 10-weeks. RESULTS: Recruitment lasted 6 months. Retention of participants at the 10-week follow-up was high (89% - performance measures; 98% - self-report questionnaires). Attendance was good with 82% of yoga and 74% of health education participants attending at least 50% of the sessions. No serious adverse events were reported. Patient satisfaction with the interventions was high. The mean effect size for the physical performance measures was 0.35 with some over 0.50. The mean effect size for self-report outcome measures was 0.36. CONCLUSIONS: Results indicate that it is feasible to conduct a larger RCT of yoga for sedentary older adults at risk for mobility problems. The yoga and comparison interventions were safe, well accepted, and well attended. Effect sizes suggest yoga may have important benefits for this population and should be studied further. TRIAL REGISTRATION: ClinicalTrials # NCT03544879 ; Retrospectively registered 4 June, 2018.

Yoga therapy for military personnel and veterans: Qualitative perspectives of yoga students and instructors.

OBJECTIVE: Millions of military personnel and veterans live with chronic mental and physical health conditions that often do not respond well to pharmacological treatments. Serious side effects and lack of treatment response have led to widespread efforts to study and promote non-pharmacological and behavioral health treatments for many chronic health conditions. Yoga is an increasingly popular mind-body intervention that has growing research support for its efficacy and safety. Our objective was to explore the attitudes, perspectives, and preferences of military personnel and veterans toward yoga as a therapeutic modality, thus providing needed information for designing and promoting yoga interventions for this population. METHODS: Participants included 24 individuals with yoga experience and current or past military service and 12 instructors who have taught yoga for military personnel and/or veterans. A semi-structured set of questions guided interviews with each participant. RESULTS: Five themes emerged from the interviews: (1) mental health benefits experienced from yoga practice; (2) physical health benefits experienced from yoga practice; (3) important yoga elements and conditions that support effective practice; (4) facilitators for engaging military in yoga practice; and (5) challenges and barriers to yoga practice for military. CONCLUSIONS: The study highlights consistent reports of mental and physical benefits of yoga practice, ongoing stigma resulting in the need for combatting and demystifying yoga and other complementary and integrative health (CIH) practices, the importance of designing interventions to address the unique mental health issues and perspectives of this population, and the importance of efforts by military leadership to bring CIH to military personnel and veterans. Rigorous research addressing these findings, along with further research on the efficacy and effectiveness of yoga interventions for treating various conditions are needed.

The effect of movement-focused and breath-focused yoga practice on stress parameters and sustained attention: A randomized controlled pilot study.

Yoga-based practices (YBP) typically involve a combination of movement sequences, conscious regulation of the breath, and techniques to engage attention. However, little is known about whether effects of YBP result from the synergistic combination of these components, or whether a subset may yield similar effects. In this study we compared the effect of a movement-focused practice and a breath-focused practice on stress parameters (perceived stress and salivary cortisol) and sustained attention (response inhibition) in yoga naïve university students. While participants of both programs showed a reduction in perceived stress and salivary cortisol, only the breath-focused group showed improvements in sustained attention. In addition, improvement in sustained attention was correlated with reduction in perceived stress but not with reduction in salivary cortisol. We discuss these findings in the context of a theoretical framework outlining bottom-up neurophysiological and top-down neurocognitive mechanisms hypothesized to be engaged by YBP.

The Essential Properties of Yoga Questionnaire (EPYQ): Psychometric Properties.

Yoga interventions are heterogeneous and vary along multiple dimensions. These dimensions may affect mental and physical health outcomes in different ways or through different mechanisms. However, most studies of the effects of yoga on health do not adequately describe or quantify the components of the interventions being implemented. This lack of detail prevents researchers from making comparisons across studies and limits our understanding of the relative effects of different aspects of yoga interventions. To address this problem, we developed the Essential Properties of Yoga Questionnaire (EPYQ), which allows researchers to objectively characterize their interventions. We present here the reliability and validity data from the final phases of this measure-development project. Analyses identified fourteen key dimensions of yoga interventions measured by the EPYQ: acceptance/compassion, bandhas, body awareness, breathwork, instructor mention of health benefits, individual attention, meditation and mindfulness, mental and emotional awareness, physicality, active postures, restorative postures, social aspects, spirituality, and yoga philosophy. The EPYQ demonstrated good reliability, as assessed by internal consistency and test-retest reliability analysis, and evidence suggests that the EPYQ is a valid measure of multiple dimensions of yoga. The measure is ready for use by clinicians and researchers. Results indicate that, currently, trained objective raters should score interventions to avoid reference frame errors and potential rating bias, but alternative approaches may be developed. The EPYQ will allow researchers to link specific yoga dimensions to identifiable health outcomes and optimize the design of yoga interventions for specific conditions.

Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial.

INTRODUCTION: Chronic low back pain (cLBP) is prevalent, especially among military veterans. Many cLBP treatment options have limited benefits and are accompanied by side effects. Major efforts to reduce opioid use and embrace nonpharmacological pain treatments have resulted. Research with community cLBP patients indicates that yoga can improve health outcomes and has few side effects. The benefits of yoga among military veterans were examined. DESIGN: Participants were randomized to either yoga or delayed yoga treatment in 2013-2015. Outcomes were assessed at baseline, 6 weeks, 12 weeks, and 6 months. Intention-to-treat analyses occurred in 2016. SETTING/PARTICIPANTS: One hundred and fifty military veterans with cLBP were recruited from a major Veterans Affairs Medical Center in California. INTERVENTION: Yoga classes (with home practice) were led by a certified instructor twice weekly for 12 weeks, and consisted primarily of physical postures, movement, and breathing techniques. MAIN OUTCOME MEASURES: The primary outcome was Roland-Morris Disability Questionnaire scores after 12 weeks. Pain intensity was identified as an important secondary outcome. RESULTS: Participant characteristics were mean age 53 years, 26% were female, 35% were unemployed or disabled, and mean back pain duration was 15 years. Improvements in Roland-Morris Disability Questionnaire scores did not differ between the two groups at 12 weeks, but yoga participants had greater reductions in Roland-Morris Disability Questionnaire scores than delayed treatment participants at 6 months -2.48 (95% CI= -4.08, -0.87). Yoga participants improved more on pain intensity at 12 weeks and at 6 months. Opioid medication use declined among all participants, but group differences were not found. CONCLUSIONS: Yoga improved health outcomes among veterans despite evidence they had fewer resources, worse health, and more challenges attending yoga sessions than community samples studied previously. The magnitude of pain intensity decline was small, but occurred in the context of reduced opioid use. The findings support wider implementation of yoga programs for veterans. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02524158.

Yoga as a treatment for chronic low back pain: A systematic review of the literature.

OBJECTIVES: Chronic low back pain (CLBP) affects millions of people worldwide, and appears to be increasing in prevalence. It is associated not only with pain, but also with increased disability, psychological symptoms, and reduced quality of life. There are various treatment options for CLBP, but no single therapy stands out as being the most effective. In the past 10 years, yoga interventions have been studied as a CLBP treatment approach. The objective of this paper is to review the current literature supporting the efficacy of yoga for CLBP. METHODS: A literature search through the beginning of 2015 was conducted in Pub Med for randomized control trials addressing treatment of CLBP with yoga. RESULTS: In this review we evaluate the use of yoga as a treatment for CLBP. Specifically we evaluate how yoga impacts physical functioning and disability, pain, and associated psychological symptoms. We also evaluate possible mediators of the effect of yoga and the safety of yoga. DISCUSSION: With few exceptions, previous studies and the recent randomized control trials (RCTs) indicate that yoga can reduce pain and disability, can be practiced safely, and is well received by participants. Some studies also indicate that yoga may improve psychological symptoms, but these effects are currently not as well established.

Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations. METHODS/DESIGN: This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records. DISCUSSION: This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02224183.

Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.

Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2× weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans.

The Essential Properties of Yoga Questionnaire: Development and Methods.

Yoga interventions have considerable heterogeneity, are multi-dimensional, and may impact health in different ways. However, most research reports regarding the effects of yoga on health and wellbeing do not adequately describe the components of the yoga interventions being used. Thus, drawing comparisons across studies or understanding the relative effects of specific aspects of a yoga intervention are rarely possible. To address this problem, we created the Essential Properties of Yoga Questionnaire (EPYQ) Project, an NCCAM-funded set of studies to develop a translational tool for yoga researchers. Here we describe the methods and developmental processes used in the EPYQ Project in detail. The project consists of four main phases. Phase I was designed to gain a comprehensive understanding of the relevant aspects of yoga by conducting a comprehensive systematic literature review and conducting focus groups with stakeholders including a wide variety of yoga teachers and students. In Phase II, a pool of potential questionnaire items was developed for the prototypic questionnaire using information from Phase I. Cognitive interviews were conducted with the preliminary EPYQ items to assess the perceived clarity, meaning, and importance of each item. In Phase III, the prototypic questionnaire was administered to two large samples of yoga students and instructors. Military personnel and veterans who practiced or taught yoga (n = 329) were recruited to participate. Factor analysis and item response theory were used to identify factors and select the final questionnaire items. Phase IV is ongoing and will collect reliability and validity data on the final instrument. Results are expected to be available in 2016. The EPYQ will provide an objective tool for describing the amount of various components of yoga interventions, eventually allowing researchers to link specific yoga components to health benefits, and facilitating the design of yoga interventions for specific health conditions.

Integrated Care Increases Treatment and Improves Outcomes of Patients With Chronic Hepatitis C Virus Infection and Psychiatric Illness or Substance Abuse.

BACKGROUND & AIMS: Patients with hepatitis C virus (HCV) infection with psychiatric disorders and/or substance abuse face significant barriers to antiviral treatment. New strategies are needed to improve treatment rates and outcomes. We investigated whether an integrated care (IC) protocol, which includes multidisciplinary care coordination and patient case management, could increase the proportion of patients with chronic HCV infection who receive antiviral treatment (a combination of interferon-based and direct-acting antiviral agents) and achieve a sustained virologic response (SVR). METHODS: We performed a prospective randomized trial at 3 medical centers in the United States. Participants (n = 363 patients attending HCV clinics) had been screened and tested positive for depression, post-traumatic stress disorder, and/or substance use; they were assigned randomly to groups that received IC or usual care (controls) from March 2009 through February 2011. A midlevel mental health practitioner was placed at each HCV clinic to provide IC with brief mental health interventions and case management, according to formal protocol. The primary end point was SVR. RESULTS: Of the study participants, 63% were non-white, 51% were homeless in the past 5 years, 64% had psychiatric illness, 65% were substance abusers within 1 year before enrollment, 57% were at risk for post-traumatic stress disorder, 71% had active depression, 80% were infected with HCV genotype 1, and 23% had advanced fibrosis. Over a mean follow-up period of 28 months, a greater proportion of patients in the IC group began receiving antiviral therapy (31.9% vs 18.8% for controls; P = .005) and achieved a SVR (15.9% vs 7.7% of controls; odds ratio, 2.26; 95% confidence interval, 1.15-4.44; P = .018). There were no differences in serious adverse events between groups. CONCLUSIONS: Integrated care increases the proportion of patients with HCV infection and psychiatric illness and/or substance abuse who begin antiviral therapy and achieve SVRs, without serious adverse events. ClinicalTrials.gov # NCT00722423.

A systematic scoping review of yoga intervention components and study quality.

CONTEXT: The scientific study of yoga requires rigorous methodology. This review aimed to systematically assess all studies of yoga interventions to (1) determine yoga intervention characteristics; (2) examine methodologic quality of the subset of RCTs; and (3) explore how well these interventions are reported. EVIDENCE ACQUISITION: Searches were conducted through April 2012 in PubMed, PsycINFO, Ageline, and Ovid's Alternative and Complementary Medicine database using the text term yoga, and through handsearching five journals. Original studies were included if the intervention (1) consisted of at least one yoga session with some type of health assessment; (2) targeted adults aged ≥18 years; (3) was published in an English-language peer-reviewed journal; and (4) was available for review. EVIDENCE SYNTHESIS: Of 3,062 studies identified, 465 studies in 30 countries were included. Analyses were conducted through 2013. Most interventions took place in India (n=228) or the U.S. (n=124), with intensity ranging from a single yoga session up to two sessions per day. Intervention lengths ranged from one session to 2 years. Asanas (poses) were mentioned as yoga components in 369 (79%) interventions, but were either minimally or not at all described in 200 (54%) of these. Most interventions (74%, n=336) did not include home practice. Of the included studies, 151 were RCTs. RCT quality was rated as poor. CONCLUSIONS: This review highlights the inadequate reporting and methodologic limitations of current yoga intervention research, which limits study interpretation and comparability. Recommendations for future methodology and reporting are discussed.

Serial case reporting yoga for idiopathic and degenerative scoliosis.

BACKGROUND: Non-surgical techniques for treating scoliosis frequently focus on realigning the spine, typically by muscular relaxation or muscular or ligamentous stretching. However, such treatments, which include physical therapeutic, chiropractic, and bracing techniques, are inconsistently supported by current evidence. In this study, we assess the possible benefits of asymmetrical strengthening of truncal muscles on the convex side of the scoliotic curve through a single yoga pose, the side plank pose, in idiopathic and degenerative scoliosis. METHODS: Twenty-five patients with idiopathic or degenerative scoliosis and primary curves measuring 6 to 120 degrees by the Cobb method had spinal radiographs and were then taught the side plank pose. After 1 week performing the pose with convexity downward for 10 to 20 seconds, they were instructed to maintain the posture once daily for as long as possible on that one side only. A second series of spinal radiographs was taken 3 to 22 months later. Pre- and post-yoga Cobb measurements were compared. RESULTS: The mean self-reported practice of the yoga pose was 1.5 minutes per day, 6.1 days per week, for a mean follow-up period of 6.8 months. Among all patients, a significant improvement in the Cobb angle of the primary scoliotic curve of 32.0% was found. Among 19 compliant patients, the mean improvement rose to 40.9%. Improvements did not differ significantly among adolescent idiopathic and degenerative subtypes (49.6% and 38.4%, respectively). CONCLUSIONS: Asymmetrically strengthening the convex side of the primary curve with daily practice of the side plank pose held for as long as possible for an average of 6.8 months significantly reduced the angle of primary scoliotic curves. These results warrant further testing.

Increasing antiviral treatment through integrated hepatitis C care: a randomized multicenter trial.

Most individuals infected with the hepatitis C have not received antiviral treatment, with mental health and substance abuse problems being the primary barrier. Interventions have been developed to address these barriers among HCV patients considered "high-risk" for antiviral treatment. We present the design and methods of a prospective, randomized controlled multisite trial being conducted in the Veterans Affairs Healthcare System. The study employed a parallel design and the three study sites randomized a total of 364 VA patients with HCV to either Integrated Care (IC) or Usual Care (UC). The IC intervention consisted of a mental health provider (MHP) performing a) brief interventions to address risk factors; b) collaborative consultation with the HCV treatment clinicians; and c) case management prior to and during antiviral treatment. Clinical outcomes were abstracted from patient medical records and self-report questionnaires were completed at baseline, 4-months, 16-months, and 22-months after enrollment. The primary outcome of the study was sustained viral response (SVR). Secondary clinical outcomes were HCV treatment initiation and completion rates. Other secondary outcomes included substance use, depression, PTSD symptoms, quality of life, healthcare satisfaction, and healthcare utilization. The Integrated Care intervention has the potential to transform HCV antiviral treatment by increasing the number of HCV-infected individuals that can be successfully treated.

An economic analysis of traditional and technology-based approaches to weight loss.

BACKGROUND: The financial burden and human losses associated with noncommunicable diseases necessitate cost-effective and efficacious interventions. PURPOSE: An economic analysis of the Lifestyle Education for Activity and Nutrition (LEAN) Study; an RCT that examined the efficacy of traditional and technology-based approaches to weight loss. METHODS: Economic analyses from an organizational perspective were conducted for four approaches: standard care control (SC); group weight-loss education (GWL); a multisensor armband (SWA); and the armband in combination with group weight-loss education (GWL+SWA). Data were collected in 2008-2009. Weight loss was the primary outcome. Total costs, costs per participant, costs per kilogram lost, and incremental cost-effectiveness ratios (ICERs) were calculated in 2010-2011. All costs are the actual expenses (i.e., staff time and materials) incurred by the LEAN study (except where noted) and reported in 2010 U.S. dollars. RESULTS: In the sample population of 197 sedentary, overweight, and obese adults (mean [±SD] age=46.9 ± 0.8 years, BMI=33.3 ± 5.2, weight=92.8 ± 18.4 kg), the GWL+SWA was the most expensive intervention in costs/participant ($365/partic) while yielding the greatest weight loss/partic (6.59 kg). The GWL was next in cost/partic ($240), but the SWA was less expensive in cost/partic ($183) and more efficacious (3.55 vs 1.86 kg/partic). The SC did not achieve significant weight loss. The SWA was the most cost effective ($51/partic/kg lost), followed by the GWL+SWA ($55) and GWL alone ($129). The ICER suggests that for each additional kilogram lost, the GWL+SWA cost $60 more than the SWA alone. CONCLUSIONS: The SWA was the most cost-effective intervention ($51/partic/kg lost). The addition of the GWL increased the efficacy of the SWA intervention but increased costs by $60/partic for each additional kilogram lost. The technology-based approaches were more cost effective and efficacious than traditional approaches in promoting weight loss via lifestyle changes in sedentary, overweight, and obese adults.