Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Background: In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

The effects of a Hatha yoga intervention on facets of distress tolerance

Item does not contain fulltextIndividuals with low distress tolerance (DT) experience negative emotion as particularly threatening and are highly motivated to reduce or avoid such affective experiences. Consequently, these individuals have difficulty regulating emotions and tend to engage in maladaptive strategies, such as overeating, as a means to reduce or avoid distress. Hatha yoga encourages one to implement present-centered awareness and non-reaction in the face of physical and psychological discomfort and, thus, emerges as a potential strategy for increasing DT. To test whether a hatha yoga intervention can enhance DT, a transdiagnostic risk and maintenance factor, this study randomly assigned females high in emotional eating in response to stress (N = 52) either to an 8-week, twice-weekly hatha (Bikram) yoga intervention or to a waitlist control condition. Self-reported DT and emotional eating were measured at baseline, weekly during treatment, and 1-week post-treatment. Consistent with prediction, participants in the yoga condition reported greater increases in DT over the course of the intervention relative to waitlist participants (Cohen's d = .82). Also consistent with prediction, the reduction in emotional eating was greater for the yoga condition than the waitlist condition (Cohen's d = .92). Importantly, reductions distress absorption, a specific sub-facet of DT, accounted for 15% of the variance in emotional eating, a hallmark behavior of eating pathology and risk factor for obesity

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

Item does not contain fulltextObjective: 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

Distress tolerance as a predictor of adherence to a yoga intervention: Moderating roles of BMI and body image

Contains fulltext : 161732.pdf (publisher's version ) (Closed access)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

Reducing approach bias to achieve smoking cessation: A pilot randomized placebo-controlled trial

Item does not contain fulltextThis study aimed to provide a preliminary test of the efficacy of a brief cognitive bias modification program for reducing approach bias in adult smokers motivated to quit. Participants were 52 smokers who were randomly assigned to four sessions of approach bias modification training (AAT) or sham training. Participants were asked to make a self-guided quit attempt upon completion of the final training session. Approach bias was assessed at baseline and at the end of each session, and days abstinent was assessed 1-week following the quit attempt. Individuals assigned to the AAT training condition evidenced significantly greater reductions in approach bias relative to those in the sham condition (p  0.41); however, higher levels of approach bias at baseline were associated with greater approach bias reduction over time irrespective of condition (p < .001). Consistent with hypothesis, the reduction in approach bias during the intervention period was significantly related to the number of days abstinent following the quit attempt (p = .033). The present study extends recent work in alcohol use disorders by showing that approach bias reduction, in this case for smoking-related stimuli, may also facilitate smoking cessation. Clinical and research implications are discussed

Approach bias retraining to augment smoking cessation: Study protocol for a randomized controlled trial

Contains fulltext : 201945.pdf (publisher's version ) (Open Access)Heavy users and addicted individuals have shown to develop an approach action tendency - or approach bias - toward stimuli related to the substance of interest. Emerging evidence points to approach bias retraining (ABR) as an effective aid for the treatment of addictive behaviors. The current study seeks to extend this work by testing, in a pilot study, whether standard smoking cessation treatment involving cognitive-behavioral therapy (CBT) and nicotine replacement therapy can be augmented by ABR. To this end, we will randomly assign 100 adult smokers to either ABR-augmented treatment or placebo-augmented treatment and compare the two conditions on short-term and long-term abstinence rates. The hope is that the findings of this study can inform treatment development for adult smokers.7 p

Anxiety sensitivity and smoking variability among treatment seeking smokers

Objectives: Anxiety sensitivity (AS) is associated with poor smoking cessation outcomes. One reason may be that smokers with high AS smoke differently (ie, to manage negative affect and uncomfortable bodily sensations) than other smokers, leading to stronger addiction (due to an affect/sensation based and thereby highly variable rather than a regular smoking routine). Thus, we examined the relationship between AS and smoking variability in a group of treatment-seeking smokers. Methods: Participants (N=136; 52.2% female; Mage=44.19 y, SD=11.29) were daily smokers with elevated AS (AS>=20 on the Anxiety Sensitivity Index 16-item at prescreen) recruited as part of a larger randomized controlled trial for smoking cessation. Most participants were white (73%), educated (with 76% attending some college), unmarried (73%), and employed full-time (56%). They smoked, on average, 17 cigarettes per day. Results: Consistent with prediction, a regression analysis of baseline assessments and a longitudinal analysis with multilevel modeling both showed higher AS was associated with greater variability in cigarettes smoked per day while controlling for sex, age, ethnicity, and income. Conclusions: This finding encourages investigation of how AS might interact with clinical strategies using a fixed smoking taper as part of quit attempts

Exercise self-efficacy moderates the relation between anxiety sensitivity and body mass index and exercise tolerance in treatment-seeking smokers

There is little known about factors that contribute to the comorbidity of cigarette smoking and obesity. The current study sought to test whether exercise self-efficacy moderated the relation between anxiety sensitivity (fear of internal sensations) and BMI and exercise tolerance among cigarette smokers. Smokers (n = 72; 50% female; Mcpd = 19.3, SD = 10.65) were recruited to participate in a smoking cessation treatment trial. During medical screen, we measured weight, height, and exercise tolerance (functional capacity) employing a standardized maximal exercise testing protocol. After adjusting for participant sex and cigarettes per day, exercise self-efficacy moderated the association between anxiety sensitivity and BMI, such that the positive association between anxiety sensitivity and BMI was significantly stronger when exercise self-efficacy was low. The same pattern of results emerged for exercise tolerance. Exercise self-efficacy moderated the association between anxiety sensitivity and exercise tolerance, such that the negative association between anxiety sensitivity and exercise tolerance was significantly stronger when exercise self-efficacy was low. Among smokers, anxiety sensitivity may be a risk variable that, directly and indirectly in the context of low self-efficacy for exercise, causes or maintains higher body weight and lower exercise tolerance