Effect of cognitive behavioural therapy and yoga for generalised anxiety disorder on sleep quality in a randomised controlled trial: the role of worry, mindfulness, and perceived stress as mediators.

Sleep disturbances are present in ~65% of individuals with generalised anxiety disorder (GAD). Although both Kundalini yoga (KY) and cognitive behavioural therapy (CBT) are effective treatment options for GAD, little is known about how these treatments compare in improving sleep for GAD and what drives these changes. Accordingly, we examined the effects of CBT, KY, and stress education (SEdu; an attention control condition) on subjective sleep quality (as measured by the Pittsburgh Sleep Quality Index [PSQI] and Insomnia Severity Index [ISI]) in a randomised controlled trial of 226 adults with GAD (mean age 33.37 years; 70% female; 79% White). We hypothesised that both CBT and KY would outperform SEdu in improving sleep disturbances. Three potential mediators of sleep improvement (worry, mindfulness, perceived stress) were also examined. In line with hypotheses, PSQI and ISI scores significantly improved from pre- to post-treatment for all three treatment groups (all p < 0.001, all d > 0.97). However, contrary to predictions, sleep changes were not significantly greater for CBT or KY compared to SEdu. In mediation analyses, within-person deviations in worry, mindfulness, and stress each significantly mediated the effect of time on sleep outcomes. Degree of change in sleep attributable to worry (CBT > KY > SEdu) and perceived stress (CBT, KY > SEdu) was moderated by treatment group. Personalised medicine as well as combined treatment approaches should be studied to help reduce sleep difficulties for patients with GAD who do not respond.

Comparing Kundalini Yoga, cognitive behavioral therapy, and stress education for generalized anxiety disorder: Anxiety and depression symptom outcomes.

Increasingly, individuals with anxiety disorders are seeking mind-body interventions (e.g., yoga), but their effectiveness is unclear. This report summarizes seven additional, secondary outcomes measuring anxiety and depression symptoms from a study of 226 adults with generalized anxiety disorder who were randomized to 12-week Kundalini Yoga, Cognitive-Behavior Therapy (CBT) or stress education (control). At post-treatment, participants receiving CBT displayed significantly lower symptom severity, compared to those in the control group, on 6 of the 7 measures. Participants who received Yoga (vs. those in the control group) displayed lower symptom severity on 3 of the 7 measures. No significant differences were detected between participants receiving CBT vs those receiving Yoga. At the 6-month follow-up, participants from the CBT continued to display lower symptoms than the control group.

Biofeedback Training to Increase P co2 in Asthma With Elevated Anxiety: A One-Stop Treatment of Both Conditions?

OBJECTIVE: Anxiety is highly prevalent in individuals with asthma. Asthma symptoms and medication can exacerbate anxiety, and vice versa. Unfortunately, treatments of comorbid anxiety and asthma are largely lacking. A problematic feature common to both conditions is hyperventilation. It adversely affects lung function and symptoms in asthma and anxiety. We examined whether a treatment to reduce hyperventilation, shown to improve asthma symptoms, also improves anxiety in asthma patients with high anxiety. METHOD: One hundred twenty English- or Spanish-speaking adult patients with asthma were randomly assigned to either Capnometry-Assisted Respiratory Training (CART) to raise P co2 or feedback to slow respiratory rate (SLOW). Although anxiety was not an inclusion criterion, 21.7% met clinically relevant anxiety levels on the Hospital Anxiety and Depression Scale (HADS). Anxiety (HADS-A) and depression (HADS-D) scales, anxiety sensitivity (Anxiety Sensitivity Index [ASI]), and negative affect (Negative Affect Scale of the Positive Affect Negative Affect Schedule) were assessed at baseline, posttreatment, 1-month follow-up, and 6-month follow-up. RESULTS: In this secondary analysis, asthma patients with high baseline anxiety showed greater reductions in ASI and PANAS-N in CART than in SLOW ( p values ≤ .005, Cohen d values ≥ 0.58). Furthermore, at 6-month follow-up, these patients also had lower ASI, PANAS-N, and HADS-D in CART than in SLOW ( p values ≤ .012, Cohen d values ≥ 0.54). Patients with low baseline anxiety did not have differential outcomes in CART than in SLOW. CONCLUSIONS: For asthma patients with high anxiety, our brief training designed to raise P co2 resulted in significant and sustained reductions in anxiety sensitivity and negative affect compared with slow-breathing training. The findings lend support for P co2 as a potential physiological target for anxiety reduction in asthma. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00975273 .

Impact of preference for yoga or cognitive behavioral therapy in patients with generalized anxiety disorder on treatment outcomes and engagement.

There is some, but inconsistent, evidence to suggest that matching patient treatment preference enhances treatment engagement and outcome. The current study examined differential preferences and factors associated with treatment preference for 12-week group cognitive behavioral therapy (CBT), yoga, or stress education in 226 adults with generalized anxiety disorder (GAD; 70% female, Mean age = 33 ± 13.5). In a subsample of 165 patients who reported an intervention preference and were randomized to yoga or CBT, we further examined whether match to preferred intervention improved the primary treatment outcome (responder status on Clinical Global Impressions Scale) and engagement (dropout, homework compliance). Preferences for CBT (44%) and yoga (40%) were similar among patients. Women tended to prefer yoga (OR = 2.75, p = .01) and CBT preference was associated with higher baseline perceived stress (OR = 0.92, p = .04) and self-consciousness meta-cognitions (OR = 0.90, p = .02). Among those not matched to their preference, treatment response was higher for those receiving CBT than yoga (OR = 11.73, p = .013); there were no group differences for those matched to their treatment preference. In yoga, those who received their preference were more likely to drop than those who did not (OR = 3.02, 95% CI = [1.20, 7.58], p = .037). This was not the case for CBT (OR = 0.37, 95% CI = [0.13, 1.03], p = .076). Preference match did not predict homework compliance. Overall, results suggest that treatment preference may be important to consider to optimize outcome and engagement; however, it may vary by treatment modality. Future research incorporating preference, especially with yoga for anxiety, is aligned with personalized medicine. TRIAL REGISTRATION: clinicaltrials.gov: NCT01912287; https://clinicaltrials.gov/ct2/show/NCT01912287.

Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial.

Importance: Generalized anxiety disorder (GAD) is common, impairing, and undertreated. Although many patients with GAD seek complementary and alternative interventions, including yoga, data supporting yoga's efficacy or how it compares to first-line treatments are lacking. Objectives: To assess whether yoga (Kundalini yoga) and cognitive behavioral therapy (CBT) for GAD are each more effective than a control condition (stress education) and whether yoga is noninferior to CBT for the treatment of GAD. Design, Setting, and Participants: For this randomized, 3-arm, controlled, single-blind (masked independent raters) clinical trial, participants were recruited from 2 specialty academic centers starting December 1, 2013, with assessment ending October 25, 2019. Primary analyses, completed by February 12, 2020, included superiority testing of Kundalini yoga and CBT vs stress education and noninferiority testing of Kundalini yoga vs CBT. Interventions: Participants were randomized to Kundalini yoga (n = 93), CBT for GAD (n = 90), or stress education (n = 43), which were each delivered to groups of 4 to 6 participants by 2 instructors during twelve 120-minute sessions with 20 minutes of daily homework. Main Outcomes and Measures: The primary intention-to-treat outcome was acute GAD response (Clinical Global Impression-Improvement Scale score of much or very much improved) after 12 weeks as assessed by trained independent raters. Results: Of 538 participants who provided consent and were evaluated, 226 (mean [SD] age, 33.4 [13.5] years; 158 [69.9%] female) with a primary diagnosis of GAD were included in the trial. A total of 155 participants (68.6%) completed the posttreatment assessment. Completion rates did not differ (Kundalini yoga, 60 [64.5%]; CBT, 67 [74.4%]; and stress education, 28 [65.1%]: χ2 = 2.39, df = 2, P = .30). Response rates were higher in the Kundalini yoga group (54.2%) than in the stress education group (33.%) (odds ratio [OR], 2.46 [95% CI, 1.12-5.42]; P = .03; number needed to treat, 4.59 [95% CI, 2.52-46.19]) and in the CBT group (70.8%) compared with the stress education group (33.0%) (OR, 5.00 [95% CI, 2.12-11.82]; P < .001; number needed to treat, 2.62 [95% CI, 1.91-5.68]). However, the noninferiority test did not find Kundalini yoga to be as effective as CBT (difference, 16.6%; P = .42 for noninferiority). Conclusions and Relevance: In this trial, Kundalini yoga was efficacious for GAD, but the results support CBT remaining first-line treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT01912287.

Targeting cognitive and emotional regulatory skills for smoking prevention in low-SES youth: A randomized trial of mindfulness and working memory interventions.

Research to date provides striking evidence that youth from low socio-economic status (SES) households are at an increased risk for smoking. Converging evidence from developmental studies, psychopathology studies, intervention studies, and basic research on self-control abilities have identified working memory and distress tolerance as potential crucial modifiable risk factors to prevent smoking onset in this cohort. To confirm the value of these mechanistic targets, this randomized trial was designed to evaluate the influence of working memory and distress tolerance interventions on risk of smoking initiation. Recruiting primarily from low-income community afternoon programs, we randomized 93 adolescents to one of three intervention conditions, all of which were a prelude to a smoking-prevention informational intervention: (1) a working memory intervention, (2) a mindfulness training intervention to target distress tolerance, and (3) a wellness-focused control condition. Despite a number of adherence efforts, engagement in treatment was limited, and under these conditions no significant evidence was found either for differential efficacy for smoking prevention or for intervention effects on mechanistic targets. However, working memory capacity and distress tolerance were found to be negatively related to smoking propensity. As such, our mechanistic targets-working memory and distress tolerance--may well be processes undergirding smoking, despite the fact that our interventions did not adequately engage these targets.

Beetroot juice supplementation for the prevention of cold symptoms associated with stress: A proof-of-concept study.

OBJECTIVES: Psychological stress has been linked to common cold symptoms. Nitric oxide (NO) is part of the first line of epithelial defense against pathogens, and beetroot juice is a source of dietary nitrate that increases NO availability. We therefore tested whether beetroot juice protects against cold symptoms in a period of sustained acute stress. DESIGN: Seventy-six students, 16 of these with asthma, were randomly assigned to seven daily doses of beetroot juice or no supplementation control during their final exams. METHODS: Participants completed stress ratings, a cold symptom questionnaire, and exhaled NO measurements at a low-stress period and two periods during their final exams, with one questionnaire follow-up assessment seven days after finals. RESULTS: Beetroot juice was associated with reduced symptoms of cold and sickness during and following finals. Those with asthma showed the greatest benefits. Higher exhaled NO was concurrently and prospectively associated with reduced symptomatology. CONCLUSION: Beetroot juice during periods of psychological stress protects against cold symptoms. Preliminary evidence suggests particular benefits in asthma, which could translate into reduced asthma exacerbations due to respiratory infections. Clinical Trial ID: NCT03159273.

Community Study of Outcome Monitoring for Emotional Disorders in Teens (COMET): A comparative effectiveness trial of a transdiagnostic treatment and a measurement feedback system.

Emotional disorders, encompassing a range of anxiety and depressive disorders, are the most prevalent and comorbid psychiatric disorders in adolescence. Unfortunately, evidence-based psychosocial therapies typically focus on single disorders, are rarely adopted by community mental health center clinicians, and effect sizes are modest. This article describes the protocol for a comparative effectiveness study of two novel interventions designed to address these challenges. The first intervention is a transdiagnostic treatment (the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents, UP-A), a promising new approach that uses a small number of common strategies to treat a broad range of emotional disorders, and their underlying shared emotional vulnerabilities. The second intervention is a standardized measurement feedback system, the Youth Outcomes Questionnaire (YOQ), designed to improve clinical decision making using weekly symptom and relational data. The three study arms are treatment as usual (TAU), TAU plus the YOQ (TAU+), and UP-A (used in combination with the YOQ). The primary aims of the study are to [1] compare the effects of the UP-A and TAU+ to TAU in community mental health clinics, [2] to isolate the effects of measurement and feedback by comparing the UP-A and TAU+ condition, and [3] to examine the mechanisms of action of both interventions. Design considerations and study methods are provided to inform future effectiveness research.

Acute ingestion of beetroot juice increases exhaled nitric oxide in healthy individuals.

BACKGROUND AND OBJECTIVE: Nitric oxide (NO) plays an important role in the airways' innate immune response, and the fraction of exhaled NO at a flow rate of 50mL per second (FENO50) has been utilized to capture NO. Deficits in NO are linked to loss of bronchoprotective effects in airway challenges and predict symptoms of respiratory infection. While beetroot juice supplements have been proposed to enhance exercise performance by increasing dietary nitrate consumption, few studies have examined the impact of beetroot juice or nitrate supplementation on airway NO in contexts beyond an exercise challenge, which we know influences FENO50. METHODS: We therefore examined the influence of a beetroot juice supplement on FENO50 in healthy males and females (n = 38) during periods of rest and in normoxic conditions. FENO50, heart rate, blood pressure, and state affect were measured at baseline, 45 minutes, and 90 minutes following ingestion of 70ml beetroot juice (6.5 mmol nitrate). Identical procedures were followed with ingestion of 70ml of water on a control day. RESULTS: After beetroot consumption, average values of the natural log of FENO50 (lnFENO50) increased by 21.3% (Cohen's d = 1.54, p < .001) 45 minutes after consumption and by 20.3% (Cohen's d = 1.45, p < .001) 90 min after consumption. On the other hand, only very small increases in FENO50 were observed after consumption of the control liquid (less than 1% increase). A small subset (n = 4) of participants completed an extended protocol lasting over 3 hours, where elevated levels of FENO50 persisted. No significant changes in cardiovascular measures were observed with this small single dose of beetroot juice. CONCLUSION: As NO serves a key role in innate immunity, future research is needed to explore the potential clinical utility of beetroot and dietary nitrate to elevate FENO50 and prevent respiratory infection.

Heated hatha yoga to target cortisol reactivity to stress and affective eating in women at risk for obesity-related illnesses: A randomized controlled trial.

OBJECTIVE: Cortisol reactivity to stress is associated with affective eating, an important behavioral risk factor for obesity and related metabolic diseases. Yoga practice is related to decreases in stress and cortisol levels, thus emerging as a potential targeted complementary intervention for affective eating. This randomized controlled trial examined the efficacy of a heated, hatha yoga intervention for reducing cortisol reactivity to stress and affective eating. METHOD: Females (N = 52; ages 25-46 years; 75% White) at risk for obesity and related illnesses were randomly assigned to 8 weeks of Bikram Yoga practice or to waitlist control. Cortisol reactivity to a laboratory stress induction were measured at Weeks 0 (pretreatment) and 9 (posttreatment). Self-reported binge eating frequency and coping motives for eating were assessed at Weeks 0, 3, 6, and 9. RESULTS: Among participants with elevated cortisol reactivity at pretreatment ("high reactors"), those randomized to the yoga condition evidenced greater pre- to posttreatment reductions in cortisol reactivity (p = .042, d = .85), but there were not significant condition differences for the "low reactors" (p = .178, d = .53). Yoga participants reported greater decreases in binge eating frequency (p = .040, d = .62) and eating to cope with negative affect (p = .038, d = .54). CONCLUSIONS: This study provides preliminary support for the efficacy of heated hatha yoga for treating physiological stress reactivity and affective eating among women at risk for obesity-related illnesses. (PsycINFO Database Record

Distress Tolerance as a Predictor of Adherence to a Yoga Intervention: Moderating Roles of BMI and Body Image.

This study tested whether distress tolerance, body image, and body mass index (BMI) predicted adherence to a yoga intervention. Participants were 27 women who participated in a yoga intervention as part of a randomized controlled trial. Attendance and distress tolerance were assessed weekly, and body image and BMI were measured at baseline. Multilevel modeling revealed a three-way interaction of distress tolerance, BMI, and body image (p < .001). For participants with few body image concerns, distress tolerance was positively associated with adherence regardless of BMI (p = .009). However, for those with poor body image, increases in distress tolerance were associated with increases in adherence among overweight participants (p < .001) but lower adherence among obese participants (p = .007). Distress tolerance may be implicated in adherence to a yoga intervention, although its effects may be dependent on body image concerns, BMI, and their interaction. Research and clinical implications are discussed.

Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications.

Respiratory and cognitive mediators of treatment change in panic disorder: evidence for intervention specificity.

OBJECTIVE: There are numerous theories of panic disorder, each proposing a unique pathway of change leading to treatment success. However, little is known about whether improvements in proposed mediators are indeed associated with treatment outcomes and whether these mediators are specific to particular treatment modalities. Our purpose in this study was to analyze pathways of change in theoretically distinct interventions using longitudinal, moderated mediation analyses. METHOD: Forty-one patients with panic disorder and agoraphobia were randomly assigned to receive 4 weeks of training aimed at altering either respiration (capnometry-assisted respiratory training) or panic-related cognitions (cognitive training). Changes in respiration (PCO2, respiration rate), symptom appraisal, and a modality-nonspecific mediator (perceived control) were considered as possible mediators. RESULTS: The reductions in panic symptom severity and panic-related cognitions and the improvements in perceived control were significant and comparable in both treatment groups. Capnometry-assisted respiratory training, but not cognitive training, led to corrections from initially hypocapnic to normocapnic levels. Moderated mediation and temporal analyses suggested that in capnometry-assisted respiratory training, PCO2 unidirectionally mediated and preceded changes in symptom appraisal and perceived control and was unidirectionally associated with changes in panic symptom severity. In cognitive training, reductions in symptom appraisal were bidirectionally associated with perceived control and panic symptom severity. In addition, perceived control was bidirectionally related to panic symptom severity in both treatment conditions. CONCLUSION: The findings suggest that reductions in panic symptom severity can be achieved through different pathways, consistent with the underlying models.

Can virtual reality increase the realism of role plays used to teach college women sexual coercion and rape-resistance skills?

The present study evaluated whether virtual reality (VR) can enhance the realism of role plays designed to help college women resist sexual attacks. Sixty-two female undergraduate students were randomly assigned to either the Role Play (RP) or Virtual Role Play (VRP) conditions, which were differentiated only by the use of VR technology in the VRP condition. A multimethod assessment strategy was used to evaluate the effects of VR on the experienced realism of sexually threatening role plays. Realism was assessed by participant self-reports of negative affect and perceptions of realism, direct observation of participants' verbal displays of negative affect during the role plays, and measurements of participant heart rate during the role plays. Results indicated that VR can indeed heighten the realism of sexually threatening role plays. Discussion focuses on issues regarding the use of VR-enhanced role plays for helping college women resist sexual attacks.

Changes in respiration mediate changes in fear of bodily sensations in panic disorder.

The purpose of the study was to examine whether changes in pCO(2) mediate changes in fear of bodily sensation (as indexed by anxiety sensitivity) in a bio-behavioral treatment for panic disorder that targets changes in end-tidal pCO(2). Thirty-five panic patients underwent 4 weeks of capnometry-assisted breathing training targeting respiratory dysregulation. Longitudinal mediation analyses of the changes in fear of bodily symptoms over time demonstrated that pCO(2), but not respiration rate, was a partial mediator of the changes in anxiety sensitivity. Results were supported by cross lag panel analyses, which indicated that earlier pCO(2) levels predicted later levels of anxiety sensitivity, but not vice versa. PCO(2) changes also led to changes in respiration rate, questioning the importance of respiration rate in breathing training. The results provide little support for changes in fear of bodily sensations leading to changes in respiration, but rather suggest that breathing training targeting pCO(2) reduced fear of bodily sensations in panic disorder.

Stress effects on lung function in asthma are mediated by changes in airway inflammation.

OBJECTIVE: To examine the association of changes in current negative mood and long-term daily hassles with changes in lung function and airway inflammation in patients suffering from asthma and in healthy controls. Associations between psychological factors and asthma symptoms have been documented, but the relationship between airway inflammation and psychological factors has been largely unexplored. METHOD: Data were analyzed from 46 asthma patients and 25 controls who completed questionnaires on current mood and daily hassles at two assessments 3 months apart. Lung function was measured by spirometry (forced expiratory volume in the first second (FEV(1))) and airway inflammation by the fraction of nitric oxide in exhaled air (FeNO). Regression analyses controlling for allergen load and air pollution (ozone) were calculated to study the association between changes in psychological factors and changes in lung function and airway inflammation, and to examine the mediational role of airway inflammation in the stress-lung function association. RESULTS: In patients with asthma, increases in negative affect were associated with decreases in FEV(1) and increases in FeNO. For daily hassles, a reverse pattern of associations was found, with decreases in daily hassles linked to decreases in FEV(1) and increases in FeNO. Mediation analyses showed that FeNO was a significant mediator of the association of both negative affect and daily hassles with lung function changes. No significant associations were found for healthy controls. CONCLUSION: Psychological variables are consistently associated with spirometric lung function and airway inflammation in asthma patients. For asthma patients, effects of acute negative affect must be distinguished from more chronic distress due to daily hassles.