Search

• Noninferiority of relative motion extension (RME) plus to dynamic orthoses. • RME plus is an option to dynamic orthoses after zones V-VI tendon repair. • RME plus noninferior for range-of-motion and satisfaction at week-6 and -12. • The greatest costs were loss of wages and productivity due to time off work. There is no comparative evidence for relative motion extension (RME) orthosis with dynamic wrist-hand-finger-orthosis (WHFO) management of zones V-VI extensor tendon repairs. To determine if RME with wrist-hand-orthosis (RME plus) is noninferior to dynamic WHFO for these zones in clinical outcomes. Randomized controlled non-inferiority trial. Skilled hand therapists managed 37 participants (95% male; mean age 39 years, SD 18) with repaired zones V-VI extensor tendons randomized to RME plus (n = 19) or dynamic WHFO (n = 18). The primary outcome of percentage of total active motion (%TAM) and secondary outcomes of satisfaction, function, and quality of life were measured at week-6 and -12 postoperatively; percentage grip strength (%Grip), complication rates, and cost data at week-12. Following the intention-to-treat principle non-inferiority was assessed using linear regression analysis (5% significance) and adjusted for injury complexity factors with an analysis of costs performed. RME plus was noninferior for %TAM at week-6 (adjusted estimates 2.5; 95% CI -9.0 to 14.0), %TAM at week-12 (0.3; -6.8 to 7.5), therapy satisfaction at week-6 and -12, and orthosis satisfaction, QuickDASH, and %Grip at week-12. Per protocol analysis yielded 2 tendon ruptures in the RME plus orthoses and 1 in the dynamic WHFO. There were no differences in health system and societal cost, or quality-adjusted life years. RME plus orthosis wearers had greater injury complexity than those in dynamic WHFOs, with overall rupture rate for both groups comparatively more than reported by others; however, percentage %TAM was comparable. The number of participants needed was underestimated, so risk of chance findings should be considered. RME plus management of finger zones V-VI extensor tendon repairs is non-inferior to dynamic WHFO in %TAM, therapy and orthotic satisfaction, QuickDASH, and %Grip. Major costs associated with this injury are related to lost work time. [ABSTRACT FROM AUTHOR]

Health literacy is fundamental to people's ability to manage their health and make appropriate health decisions. Health literacy enhancement can maximize self-management and health outcomes, especially among uncontrolled type 2 diabetes persons with chronic symptoms that can cause microvascular and macrovascular complications. This randomized controlled trial examined the effects of the Enhance Health Literacy through Transformative Learning Program on self-management and HbA1C levels among adults with uncontrolled type 2 diabetes. The sample included 64 adults with uncontrolled type 2 diabetes visiting two health- promoting hospitals in a province in central Thailand. They were randomly allocated to either the experimental group (n = 32) receiving the 4-week transformative learning program in addition to usual care or the control group (n = 32) receiving only usual care. A demographic data questionnaire, the Self-Management Behaviors Scale, and the HbA1C record form were instruments for obtaining data. Data were analyzed using descriptive statistics, two-way repeated measures ANOVA, and independent t-tests. Results showed that after receiving the program, the experimental group had significantly higher self-management scores than the control group and was more elevated. In addition, the experimental group had significantly lower HbA1C levels than the control group after the intervention at 12 weeks than before receiving the program. In conclusion, the Enhance Health Literacy through Transformative Learning Program can increase self-management behaviors and lower HbA1C levels. However, nurses need to further test the effectiveness of the literacy program before implementing widely in practice. [ABSTRACT FROM AUTHOR]

Background: Scalp acupuncture has been found to be effective at improving motor function after ischemic stroke, but few studies examining its central mechanisms of action have been carried out. The aim of this study was to investigate the clinical effects of scalp acupuncture on motor dysfunction and changes in spontaneous brain activity in patients with ischemic stroke. Methods: This was an evaluator- and analyst-blinded, multi-center randomized controlled trial. A total of 108 convalescent-stage ischemic stroke patients with motor dysfunction were allocated to receive either scalp acupuncture combined with rehabilitation treatment (SR group) or rehabilitation treatment alone (RE group). Patients in both groups received treatment 5 times per week for 8 weeks. The primary outcome measure was the Fugl-Meyer assessment (FMA). Secondary outcome measures included the modified Barthel index (mBI), modified Rankin scale (mRS) and values of fractional amplitude of low frequency fluctuation (fALFF) acquired using a resting-state functional magnetic resonance imaging (rs-fMRI) technique. Results: Both groups showed significant improvements in motor function, daily life ability and degree of disability, as measured by FMA, mRS and mBI (p < 0.05), and the SR group showed a significantly greater improvement (p < 0.05). Compared with the RE group, the areas where the fALFF values increased in the SR group were located in the cerebellum, praecuneus, precentral gyrus, superior frontal gyrus and parietal lobe. The improvement in FMA scores had the strongest correlation with the baseline fALFF values of the ipsilateral precentral gyrus. Conclusion: Scalp acupuncture improved motor function in convalescent-period ischemic stroke patients, and effects were correlated with regulation of motor-relevant brain regions. The fALFF value of the ipsilateral precentral and postcentral gyri could be potential clinical indices for prognostication of motor dysfunction. Trial registration number: NCT03120650 (http://www.clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Background: More new randomized controlled trials (RCTs) on acupuncture have been published in Japan since our last updated systematic review (2010). This systematic review aimed to evaluate the quality of RCTs on acupuncture conducted in Japan and understand the decade-wise changes in the methodological characteristics of the relevant RCTs. Methods: The literature search was performed using Ichushi Web, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed and our team's compilation of relevant papers. We included full-length papers reporting RCTs that examined the clinical effects of acupuncture on patients in Japan published in or before 2019. We assessed the risk of bias (RoB), sample size, control setting, negative trial reporting, informed consent, ethics approval, trial registration, and adverse event reporting. Results: A total of 99 articles reporting 108 eligible RCTs were identified. The number of RCTs published in each decade was 1, 6, 9, 5, 40, and 47 in the 1960s, 1970s, 1980s, 1990s, 2000s, and 2010s, respectively. Quality assessment using the Cochrane RoB tool revealed that "sequence generation" improved in and after 1990 (73%–80% of RCTs were rated as "low") and "blinding of outcome assessors" slightly improved in and after the 2000s (40%–50% judged as "low"). However, "high" or "unclear" remained the dominant grades in other domains. Clinical trial registration and adverse events were reported only in 9% and 28% of the included RCTs even in the 2010s, respectively. A different acupuncture method or different point selection (e.g., deep vs. shallow insertion) was the most dominant control setting before 1990, while sham (or "placebo") needling and/or sham acupoints became the most dominant in the 2000s. The proportion of RCTs with positive results was 80% in the 2000s and 69% in the 2010s. Conclusions: The quality of RCTs on acupuncture conducted in Japan did not appear to have improved over the decades except for "sequence generation." While the culture of submitting negative trial reports was prevalent in the Japanese acupuncture research milieu as late as the 1990s, the overall quality of the relevant trials needs to be further improved. [ABSTRACT FROM AUTHOR]

Background: Neuropsychiatric symptoms, comprising cognitive impairment, fatigue, insomnia, depression, and anxiety, are prevalent and may co-occur during and after chemotherapy treatment for cancer. Electroacupuncture (EA), which involves mild electrical stimulation with acupuncture, holds great potential in addressing the management of individual symptoms. However, there is a lack of studies evaluating if EA can manage concurrent neuropsychiatric symptoms in cancer (i.e., symptom cluster). Hence, we designed a trial to evaluate the efficacy, safety, and feasibility of administering EA as an intervention to mitigate neuropsychiatric symptom clusters amongst cancer patients and survivors. Methods: The EAST study is a randomized, sham-controlled, patient- and assessor-blinded clinical trial. Sixty-four cancer patients and survivors with complaints of one or more neuropsychiatric symptom(s) in the seven days prior to enrollment are recruited from the University of California Irvine (UCI) and Children's Hospital of Orange County (CHOC). Individuals with needle phobia, metastases, bleeding disorders, electronic implants, epilepsy, exposure to acupuncture in the three months prior to enrollment, and who are breastfeeding, pregnant, or planning to get pregnant during the duration of the study will be excluded. Screening for metal fragments and claustrophobia are performed prior to the optional neuroimaging procedures. Recruited patients will be randomized (1:1) in random blocks of four or six to receive either ten weekly verum EA (treatment arm, vEA) or weekly sham EA (control arm, sEA) treatment visits with a follow-up appointment four to twelve weeks after their last treatment visit. The treatment arm will receive EA at 13 acupuncture points (acupoints) chosen for their therapeutic effects, while the control arm receives minimal EA at 7 non-disease-related acupoints. Questionnaires and cognitive assessments are administered, and blood drawn to assess changes in symptom clusters and biomarkers, respectively. Conclusion: The EAST study can provide insight into the efficacy of EA, an integrative medicine modality, in the management of cancer symptom clusters in routine clinical practice. Trial registration: This trial is registered with clinicaltrials.gov NCT05283577. [ABSTRACT FROM AUTHOR]

Background: The evidence available on the association between social support and prevention of depression has been basically obtained from observational studies. Aim: We evaluated the effectiveness of social support-based interventions for the prevention of depression in people without clinical depression. Methods: Systematic review and meta-analysis (SR/MA) of randomized controlled trials (RCT), which were searched for in MEDLINE, EMBASE, CENTRAL, WOS, PsycINFO, OpenGrey and other sources from the inception dates to June 8, 2022. We selected RCTs that assessed the effectiveness of social support-based interventions as compared to controls, included subjects without baseline clinical depression, and measured as results a reduction in depressive symptoms and/or the incidence of new cases of depression. Pooled standardized mean differences (SMDs) were calculated from random effects models. Results: Nine RCTs involving 927 patients from North America, Asia and Europe were included. The pooled SMD was −0.43 [95% confidence interval (CI) −0.82 to −0.04; p =.031]. Sensitivity analyses confirmed the robustness of results. Heterogeneity was substantial [ I 2 = 80% (95% CI: 64% to 89%)]. A meta-regression model that included usual care as comparator and the continent (Europe), explained 53% of heterogeneity. Eight RCTs had a moderate overall risk of bias and one had a high risk of bias. Follow-up was ⩾1 year in only three RCTs. There was no statistical evidence of publication bias. The quality of evidence, as measured on GRADE guidelines, was low. Conclusion: Social support-based interventions had a small preventive effect on depression. Longer RCTs with a low risk of bias are necessary. [ABSTRACT FROM AUTHOR]

Simple Summary: Effective and scalable diet, exercise, and weight management interventions are needed for primary cancer prevention in the general public, as well as for cancer control and tertiary prevention among the growing population of cancer survivors. A 6-month online intervention, entitled "Daughters, dUdes, mothErs, and others Together" (DUET), was designed to promote weight loss, a healthful diet, and increased physical activity among cancer survivors and their chosen partners. Fifty-six cancer survivor-partner dyads (n = 112 participants in total) were recruited into a randomized controlled trial that compared DUET to a waitlist control. The trial surpassed all feasibility endpoints with regard to uptake, retention, and safety; the DUET intervention also resulted in significant weight loss and reductions in caloric intake, as well as having a promising impact on physical activity and performance, blood glucose, and indicators of inflammation. (1) Background: A healthful diet, regular physical activity, and weight management are cornerstones for cancer prevention and control. Yet, adherence is low in cancer survivors and others, calling for innovative solutions. Daughters, dUdes, mothers, and othErs fighting cancer Together (DUET) is a 6-month, online, diet-and-exercise, weight-loss intervention to improve health behaviors and outcomes among cancer survivor-partner dyads. (2) Methods: DUET was tested in 56 dyads (survivors of obesity-related cancers and chosen partners) (n = 112), both with overweight/obesity, sedentary behavior, and suboptimal diets. After baseline assessment, dyads were randomized to DUET intervention or waitlist control arms; data were collected at 3- and 6-months and analyzed using chi-square, t-tests, and mixed linear models (α < 0.05). (3) Results: Retention was 89% and 100% in waitlisted and intervention arms, respectively. Dyad weight loss (primary outcome) averaged −1.1 (waitlist) vs. −2.8 kg (intervention) (p = 0.044/time-by-arm interaction p = 0.033). Caloric intake decreased significantly in DUET survivors versus controls (p = 0.027). Evidence of benefit was observed for physical activity and function, blood glucose, and c-reactive protein. Dyadic terms were significant across outcomes, suggesting that the partner-based approach contributed to intervention-associated improvements. (4) Conclusions: DUET represents a pioneering effort in scalable, multi-behavior weight management interventions to promote cancer prevention and control, calling for studies that are larger in size, scope, and duration. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to determine the efficacy of probiotic gargles compared with placebo gargles on reducing post-tonsillectomy morbidity in adults. Method: This was a triple-blind, randomised, controlled trial and feasibility study. Thirty adults underwent elective tonsillectomy and were randomly assigned to receive either probiotic or placebo gargles for 14 days after surgery. Daily pain scores and requirement of analgesia were measured for 14 days post-operatively. Secondary outcomes assessed probiotic safety and tolerability and the feasibility of the trial. Results: The probiotic group experienced less pain at rest on day 2. However, the amount of oxycodone (5 mg) tablets used was greater in the probiotic group compared with placebo. There were no statistically significant differences in the frequency of adverse effects between both groups. This trial was feasible. Conclusion: This pilot study suggested that probiotic gargles do not reduce post-tonsillectomy pain or bleeding, highlighting the importance of pilot and feasibility studies in clinical research. [ABSTRACT FROM AUTHOR]

Rationale: Pragmatic design may facilitate the generalizability of effectiveness of randomized controlled trials (RCTs) in primary health care (PHC). Aims and Objectives: The aim of this study was to investigate whether published protocols in PHC were designed pragmatically and to explore whether specific trial characteristics may be related to a pragmatic design. Methods: Using the Pragmatic Explanatory Continuum Indicator Summary‐2 (PRECIS‐2), we assessed pragmatism for 123 published RCT protocols. For each domain, we calculated the mean score with the 95% confidence interval (95% CI). Interrater reliability was assessed by weighted κ‐coefficient with 95% CI. We examined potential associations of published protocol characteristics with overall pragmatism by performing univariate and multivariate analyses. Results: We observed the highest score for primary analysis (4.66, 95% CI: 4.51, 4.82). The eligibility score was intermediate (3.16, 95% CI: 3.01, 3.32). Domains with scores towards the explanatory side included organization (2.50, 95% CI: 2.36, 2.63), flexibility of delivery (2.74, 95% CI: 2.60, 2.88) and flexibility of adherence (3.00, 95% CI: 2.83, 3.17). Interrater agreement was good (κ = 0.61; 95% CI: 0.34, 0.80; p < 0.001). Higher sample sizes were correlated to a pragmatic design (odds ratio: 6.86, 95% CI: 1.64, 28.75; p = 0.04). Conclusion: Most RCT protocols were rated as intermediate in the pragmatic‐explanatory continuum. Future research may guide all stakeholders on how best to incorporate the level of pragmatism in the interpretation of the results so that the trials are more likely to be applicable in real‐world settings. [ABSTRACT FROM AUTHOR]

Homeopathic treatment is claimed to be beneficial for primary dysmenorrhoea (PD); still, systematic research evidences remain compromised. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD. A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0–10 numeric rating scales (NRS) measuring intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively; all measured at baseline, and every month, up to 3 months. Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat (ITT) sample. Groups were comparable at baseline (all p>0.05). Attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favoured IH over placebo at all time points (all p<0.001, unpaired t-tests and two-ways repeated measures analysis of variance) with medium to large effect sizes. Natrum muriaticum and Pulsatilla nigricans (n=20 each; 15.6%) were the most frequently prescribed medicines. No harms, serious adverse events and intercurrent illnesses were recorded in either of the groups. Homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted. Trial registration: CTRI/2018/10/016013. [ABSTRACT FROM AUTHOR]

This study assessed the effects of a 12-week afterschool mindfulness-based diet and exercise intervention on mental and physical health in Latinx and Black youth. One hundred forty-eight boys and girls (average age = 10.1 years, SD = 1.3 years; 52% girls; 72.3% Latinx) were randomized to either the experimental group (n = 80) or the control group (n = 68). The experimental group participants engaged in fitness yoga, kickboxing, and/or spinning sessions, and mindfulness practices (e.g., breathing, meditation, and mindful eating) twice per week for 12 weeks. The control group participants engaged in a recreational play session once per week for 12 weeks. All participants completed surveys (demographics, acculturation, anxiety, emotional eating, sleep, and food intake) and had their height, weight, and percent body fat measured pre- and post-intervention. Participants wore an accelerometer for 7 days pre- and post-intervention. Repeated measures analysis of covariance indicated that the experimental group participants reported lower scores in emotional eating, anxiety, and sleep latency post-intervention compared to the control group participants. Conversely, no significant differences were observed in physical activity between the experimental and control group participants post-intervention. These findings indicate that a mindfulness-based intervention has a positive effect on emotional eating, anxiety, and sleep latency among youth of color. [ABSTRACT FROM AUTHOR]

Background: Childhood overweight and obesity is a public health priority. We have previously reported the efficacy of a parent-oriented mobile health (mHealth) app-based intervention (MINISTOP 1.0) which showed improvements in healthy lifestyle behaviors. However, the effectiveness of the MINISTOP app in real-world conditions needs to be established. Objective: To evaluate the real-world effectiveness of a 6-month mHealth intervention (MINISTOP 2.0 app) on children's intake of fruits, vegetables, sweet and savory treats, sweet drinks, moderate-to-vigorous physical activity, and screen time (primary outcomes), and on parental self-efficacy (PSE) for promoting healthy lifestyle behaviors, and children's body mass index (BMI) (secondary outcomes). Methods: A hybrid type 1 effectiveness-implementation design was utilized. For the effectiveness outcomes, a two-arm, individually randomized controlled trial was conducted. Parents (n = 552) of 2.5-to-3-year-old children were recruited from 19 child health care centers across Sweden, and, randomized to either a control (standard care) or intervention group (MINISTOP 2.0 app). The 2.0 version was adapted and translated into English, Somali and Arabic to increase reach. All recruitment and data collection were conducted by the nurses. Outcomes were assessed at baseline and after six months, using standardized measures (BMI) and a questionnaire (health behaviors, PSE). Results: Among the participating parents (n = 552, age: 34.1 ± 5.0 years), 79% were mothers and 62% had a university degree. Twenty-four percent (n = 132) of children had two foreign-born parents. At follow-up, parents in the intervention group reported lower intakes of sweet and savory treats (-6.97 g/day; p = 0.001), sweet drinks (-31.52 g/day; p < 0.001), and screen time (-7.00 min/day; p = 0.012) in their children compared to the control group. The intervention group reported higher total PSE (0.91; p = 0.006), PSE for promoting healthy diet (0.34; p = 0.008) and PSE for promoting physical activity behaviors (0.31; p = 0.009) compared to controls. No statistically significant effect was observed for children's BMI z-score. Overall, parents reported high satisfaction with the app, and 54% reported using the app at least once a week. Conclusion: Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their parents reported higher PSE for promoting healthy lifestyle behaviors. Our results from this real-world effectiveness trial support the implementation of the MINISTOP 2.0 app within Swedish child health care. Trial registration: Clinicaltrials.gov NCT04147039; https://clinicaltrials.gov/ct2/show/NCT04147039 [ABSTRACT FROM AUTHOR]

Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0–100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512. [ABSTRACT FROM AUTHOR]

Prenatal stress is a pressing issue. However, there is a lack of robust evidence for psychosocial interventions to manage this problem. This study aimed to examine the effectiveness of a mindfulness-based intervention on reducing prenatal stress compared to participation in health education groups. A randomized controlled trial was conducted in a prenatal clinic of comprehensive tertiary care from April to October 2017. A total of 108 pregnant women were randomly assigned to an intervention or a control group. Participants completed self-report measures of depression, anxiety, perceived stress, fatigue, positive and negative affect, and mindfulness before, immediately after, and 15 weeks after the 4-week intervention period. Generalized estimating equations were used to analyze the intervention outcomes. The results supported greater improvement in terms of perceived stress (Wald χ2=26.94, p<0.001), fatigue (Wald χ2=17.61, p<0.001), positive affect (Wald χ2=9.03, p = 0.011), negative affect (Wald χ2=11.37, p = 0.003), and mindfulness (Wald χ2=24.97, p<0.001) in the intervention group than in the control group. The self-help mindfulness intervention decreased prenatal stress and negative affect and improved positive affect and mindfulness. [ABSTRACT FROM AUTHOR]

Objective Our main aim was to investigate the effect of a single oral dose of C21, a selective angiotensin II type 2 receptor agonist, on cold-induced vasoconstriction in SSc-related RP. Methods This was a phase IIa, randomized, double-blind, cross-over, single-dose, placebo-controlled, single-centre study. Twelve female patients with SSc (median age 58.5 years, median duration of RP 19.0 years) attended on four occasions: screening, treatment visits 1 and 2 (separated by 3–7 days) and follow-up. At the first treatment visit, patients were randomized to receive either a single oral dose of C21 (200 mg) or placebo, then the opposite treatment on the second visit. Forty min after each treatment, each patient underwent a standard hand cold challenge. The primary end point was the area under the curve (AUC) for rewarming for each finger (eight fingers) over 15 min. Secondary end points included the maximum finger temperature after rewarming (MAX). Statistical analyses were performed by multiplicative ANCOVA models. Results For all eight fingers combined, mean AUC for rewarming was higher after treatment with C21 than after placebo (geometric mean 20 046°C*s vs 19 558°C*s), but not significantly (P  = 0.380) and MAX (at 15 min) was also higher (geometric mean 23.5°C vs 22.5°C; P  = 0.036). C21 was well tolerated. Conclusion Despite the small trial size, a signal emerged suggesting that even in patients with established SSc, C21 may confer benefit for RP and deserves further investigation. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov , NCT04388176. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to examine the effect of an online multidisciplinary weight loss management programme. Methods: Between July 2016 and July 2017 this randomized controlled trial recruited patients in Nanjing, China who were living with type 2 diabetes mellitus and who were obese or overweight and randomized them to online versus conventional groups. All participants were managed by a multidisciplinary team. The experimental group was managed using the Why Wait WeChat Platform for Weight Reduction Management. Results: There were 55 and 52 participants in the online and conventional groups, respectively. The decreases in fasting blood glucose (−4.26 vs. −2.99 mmol/L), 2‐h postprandial blood glucose (−4.48 vs. −2.68 mmol/L) and glycated haemoglobin (−22.11 vs. −6.21 mmol/mol) were more pronounced in the online compared to conventional group (all P < 0.05). After the intervention, self‐management ability parameters, including diet control, foot care and total score, were improved in the online group compared with the conventional group, as well as all indexes of quality of life (all P < 0.05). Conclusion: The online multidisciplinary weight loss management programme improved blood glucose in obese or overweight patients living with type 2 diabetes mellitus. Self‐management ability parameters (including diet control, foot care and total score) and quality of life were improved in the online group compared with the conventional group. Summary statement: What is already known about this topic?: Multidisciplinary approaches have been introduced into weight loss management models for patients with type 2 diabetes mellitus and obese or overweight in outpatient clinics of third‐level hospitals, but their effects have not been clearly described. What this paper adds?: The online multidisciplinary weight loss management programme improved blood glucose in obese or overweight patients living with type 2 diabetes mellitus.Self‐management ability parameters (including diet control, foot care and total score) and quality of life were improved in the online group compared with the conventional group. The implications of this paper: This is the first trial of an online programme in the management of type 2 diabetes mellitus in China.Trial findings might have international applicability in the management of type 2 diabetes mellitus and could lead to improvement of prognosis. [ABSTRACT FROM AUTHOR]

Background Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring. Methods We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert or SOC Roche COBAS (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and healthcare workers (HCWs) evaluated acceptability. Results During April 2018–October 2019, 268 SOC and 273 POC patients enrolled in the trial. Viral suppression at <1000 copies/mL at 12 months was 59.3% (162/273) for POC and 52.2% (140/268) for SOC (P =.096) in ITT analysis and 77.1% (158/205) for POC and 65.9% (137/208) for SOC (P =.012) in PP analysis. Retention was not significantly different in ITT analysis but was 85.9% for POC and 76.9% for SOC (P =.02) in PP analysis. The increased VS in the POC arm was attributable to improved retention and documentation of VL results. POC monitoring was preferred over SOC by 90.2% (147/163) of patients and 100% (15/15) of HCWs thought it facilitated patient care. Conclusions POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care. Clinical Trials Registration NCT03533868. [ABSTRACT FROM AUTHOR]

Background: Excessive noradrenergic signaling contributes to aversive symptoms of alcohol withdrawal that interfere with abstinence or reductions in harmful use. Methods: To address this aspect of alcohol use disorder, 102 active‐duty soldiers participating in command‐mandated Army outpatient alcohol treatment were randomized to also receive the brain‐penetrant alpha‐1 adrenergic receptor antagonist prazosin or placebo for 13 weeks. Primary outcomes were scores on the Penn Alcohol Craving Scale (PACS), standard drink units (SDUs) per day averaged over each week, % days of any drinking per week, and % days of heavy drinking per week. Results: PACS declines did not differ significantly between the prazosin and placebo groups in the overall sample. In the subgroup with comorbid PTSD (n = 48), PACS declines were significantly greater in the prazosin than in the placebo condition (p < 0.05). Baseline alcohol consumption was markedly reduced by the pre‐randomization outpatient alcohol treatment program, but the addition of prazosin treatment produced a greater slope of decline in SDUs per day compared to placebo (p = 0.01). Preplanned subgroup analyses were performed in soldiers with elevated baseline cardiovascular measures consistent with increased noradrenergic signaling. In soldiers with elevated standing heart rate (n = 15), prazosin reduced SDUs per day (p = 0.01), % days drinking (p = 0.03), and % days heavy drinking (p = 0.001) relative to placebo. In soldiers with elevated standing systolic blood pressure (n = 27), prazosin reduced SDUs per day (p = 0.04) and tended to reduce % days drinking (p = 0.056). Prazosin also reduced depressive symptoms and the incidence of emergent depressed mood more than placebo (p = 0.05 and p = 0.01, respectively). During the final 4 weeks of prazosin vs. placebo treatment that followed completion of Army outpatient AUD treatment, alcohol consumption in soldiers with elevated baseline cardiovascular measures increased in those receiving placebo but remained suppressed in those receiving prazosin. Conclusions: These results extend reports that higher pretreatment cardiovascular measures predict beneficial effects of prazosin, which may be useful for relapse prevention in patients with AUD. [ABSTRACT FROM AUTHOR]

Stoma bag filter-related issues, such as ballooning (the bag filling with gas), remain highly prevalent among users. The full-circle filter was purposely designed to reduce ballooning through the inclusion of a unique, full-circle pre-filter. Two similar randomized crossover trials were conducted to compare the performance of the full-circle filter with a dual filter in adults with a colostomy (n = 20) or an ileostomy (n = 20). The frequency of ballooning was significantly lower with the full-circle filter versus the dual filter in participants with a colostomy (p < 0.0007) and in participants with an ileostomy (p < 0.0001). No significant differences were observed in the frequency of other issues (pancaking, odor problems, and ostomy solution discretion) between the filters. On average, participants with an ileostomy wore ostomy solutions with the full-circle filter for 3.3 h longer than ostomy solutions with the dual filter (p < 0.0001); wear-time in users with a colostomy was comparable between the filters. Considering the lack of published research on stoma bag filters and the high prevalence of filter-related issues, these data provide important information for health care practitioners who support people living with a stoma. [ABSTRACT FROM AUTHOR]

Background: 5%–10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non‐inferiority of OST compared to multi‐session CBT for treating specific phobias in CYP. Methods: ASPECT was a pragmatic, multi‐center, non‐inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university‐based CYP well‐being service. CYP aged 7–16 years with specific phobia were randomized to receive OST or CBT. Clinical non‐inferiority and a nested cost‐effectiveness evaluation was assessed 6‐months post‐randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal‐based outcome measure, and EQ‐5DY and CHU‐9D, collected blind at baseline and six‐months. Results: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention‐to‐treat (ITT) and per‐protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale‐adjusted mean difference for CBT compared to OST ‐0.123, 95% CI −0.449 to 0.202 (ITT), mean difference −0.204, 95% CI −0.579 to 0.171 (PP)). These findings were wholly below the standardized non‐inferiority limit of 0.4, suggesting that OST is non‐inferior to CBT. No between‐group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. Conclusions: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost‐saving alternative. [ABSTRACT FROM AUTHOR]

RE-AIM is an implementation science framework that provides a structure to promote data collection and analysis in the domains of R each, E fficacy/ E ffectiveness, A doption, I mplementation, and M aintenance. The RE-AIM approach promotes more data collection and reporting than typical evaluations so potential adopters can determine the potential program fit for their setting. RE-AIM has been used to evaluate a variety of programs; however, there are few resources that provide strategies for conducting a RE-AIM evaluation in the school setting. The purpose of this article is to inform future studies by elucidating experiences conducting a large, complex, multisite, longitudinal RE-AIM evaluation in schools in partnership with the state's Departments of Education and Health, and to share strategies for overcoming obstacles. With the long-term goal of facilitating the translation of school-based intervention research into practice, we provide key considerations and recommend strategies for school-based RE-AIM evaluation success. [ABSTRACT FROM AUTHOR]

Aim: Radio‐Taiso, a traditional exercise program in Japan, may serve as a coping strategy for older adults with frailty during the COVID‐19 pandemic. This phase II trial tested program adherence and safety and explored the potential effectiveness of a home‐based Radio‐Taiso. Methods: This assessor‐blind parallel randomized controlled trial included community‐dwelling Jolder Japanese adults with frailty and pre‐frailty. Fifty‐eight eligible participants were randomly allocated to intervention and control groups. Intervention participants performed 3–5‐min sessions of Radio‐Taiso one to four times per day for 12 weeks. Feasibility criteria were set at practice and retention rates of ≥75%. Safety was monitored by assessing all adverse events reported by participants during the intervention period, irrespective of causality. Potential effectiveness was exploratorily assessed using items that allow clinical interpretation of changes: mobility and health‐related quality of life (HR‐QoL), assessed using the modified short physical performance battery (SPPB) and the SF‐36, respectively. Results: Both practice (83%) and retention rates (100%) met the predetermined feasibility criteria. Eleven adverse events were reported but were supposedly unrelated to the intervention. In the intention‐to‐treat analysis, there was no clinically significant difference in the change in SPPB score between groups (−0.4 points, 95% confidence interval [CI], −1.2, 0.3); however, the intervention group scored higher in the mental component of HR‐QoL than did the control group (3.4 points, 95% CI: −1.1, 7.8). Conclusions: The preliminary data indicate that a phase III trial is feasible, focusing on the mental aspect of HR‐QoL as the primary outcome. Geriatr Gerontol Int 2023; 23: 32–37. [ABSTRACT FROM AUTHOR]

Despite overwhelming adoption of wearable fitness trackers (WFT), it is unclear if they affect physical activity (PA) engagement or PA motivation. We hypothesized that combining a WFT with an effective intervention, motivational interviewing (MI), would positively influence both motivation and PA. A 12-week randomized controlled trial was conducted in 40 adults who did not meet PA recommendations. The four conditions were: a PA education (Educational control, n = 10), a WFT (WFT, n = 10), bi-weekly MI sessions (MI, n = 10), or both interventions (WFT+, n = 10). Motivation and PA were measured through an online survey and actigraphy pre- and post-intervention. Both the WFT+ and MI groups improved autonomous forms and decreased controlled forms of motivation. They also had higher basic psychological needs scores when compared to the Education group post-intervention. We detected no changes in PA. High autonomous motivation at baseline predicted higher post-intervention PA in the WFT+ group but predicted lower post-intervention PA in the WFT group. Results suggests that MI alone or with a WFT can improve basic psychological needs and autonomous forms of motivation for PA, but not PA participation. Individual differences in motivation at baseline may moderate the effect of a WFT on PA. This study was registered at clinicaltrials.gov (NCT490014). [ABSTRACT FROM AUTHOR]

Copyright of Journal of Physiotherapy Research / Revista Pesquisa em Fisioterapia is the property of Journal of Physiotherapy Research / Revista Pesquisa em Fisioterapia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Diabetic retinopathy is a microvascular complication of diabetes resulting in visual impairment. Controlling the progression of diabetic retinopathy and living with visual impairment are crucial tasks and skills for older people with diabetic retinopathy and visual impairment. This randomized controlled trial investigated the effects of a self- and family management support program on health outcomes of Thai older people with diabetic retinopathy and visual impairment who lived with family members in the community and on family satisfaction. Eighty-four participants were recruited at an eye-specialized hospital in a central province of Thailand and randomly assigned to either the experimental group (n = 42) or the comparison group (n = 42). The experimental group received the intervention program plus usual care, while the comparison group received only usual care. Instruments for data collection included a Demographic Data Form, the Perceived Security in Performance of Daily Life Activities Questionnaire, the Self-Management Behavior Questionnaire, the Sirindhorn National Medical Rehabilitation Center Functional Assessment, the Thai Visual Function Questionnaire 28, and the Family Satisfaction Questionnaire. Data analyses were performed using descriptive statistics, t-test, chi-square, two-way repeated measures ANOVA, and ANCOVA. Results showed that the experimental group had significantly more improved perceived security, self-management behavior, HbA1c, visual-related quality of life: performing activities dimension, and family satisfaction than the comparison group at Week 16. However, no significant differences in perceived security, self-management behavior, functional ability, and overall visual-related quality of life were found between the two groups at Week 8. This program be further tested before being implemented into practice. However, it has a potential for healthcare providers to create an intervention program encompassing disease control and skill training for older people with diabetic retinopathy and visual impairment and encourage their families to support them. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study is to compare the effect of Vitamin D and Vitamin E supplementations, alone, and in combination, on reducing the intensity and duration of dysmenorrhea in women who were referred to the Kowsar gynecological clinics of Shahid Motahari Hospital of Urmia University of Medical Sciences. Materials and Methods: A double-blinded clinical trial was conducted on 112 women with dysmenorrhea who were randomly allocated into the four study groups. Finally, 100 women complete the study and received capsules containing a placebo (n = 25), 1000 IU of Vitamin D (n = 25), 400 mg of Vitamin E (n = 25), and 1000 IU of Vitamin D + 400 mg of Vitamin E (n = 25) every 24 h for 2 consecutive months at the beginning of the menstrual period. The pain intensity and duration among groups were compared before and after the intervention. Results: The mean menstrual pain duration in all three experimental groups (Vitamin E, Vitamin D, and the combination of them) was lower than the placebo group (all P < 0.05), and the mean pain intensity scores in all three experimental groups were significantly lower than the placebo group (all P < 0.05). The results (means) for all of the drugs administered at the end of the 2nd month were better than the 1st month (all P < 0.01). Conclusions: Vitamin E and Vitamin D, as well as their combination, are recommended as an effective and safe treatment for the management of the complications of dysmenorrhea. [ABSTRACT FROM AUTHOR]

Background: Physician burnout is a common problem, with onset frequently occurring during undergraduate education. Early intervention strategies that train medical students in psychological flexibility skills could support well-being and mitigate burnout risks associated with unmodifiable career stressors. There is a need for randomized controlled trials to assess effectiveness. As psychological flexibility varies contextually and among individuals, tailoring interventions may improve outcomes. Smartphone apps can facilitate individualization and accessibility, and the evaluation of this approach is an identified research priority. Objective: This study aimed to evaluate the effectiveness of a stand-alone app--delivered Acceptance and Commitment Training intervention for improving medical students' self-reported burnout, well-being, psychological flexibility, and psychological distress outcomes. We aimed to explore whether an individualized app would demonstrate benefits over a nonindividualized version. Methods: This parallel randomized controlled trial was conducted with a sample of medical students from 2 Australian universities (N=143). Participants were randomly allocated to 1 of 3 intervention arms (individualized, nonindividualized, and waitlist) using a 1:1:1 allocation ratio. Individualized and nonindividualized participants were blinded to group allocation. The 5-week intervention included an introductory module (stage 1) and on-demand access to short skill training activities (stage 2), which students accessed at their own pace. Stage 2 was either nonindividualized or individualized to meet students' identified psychological flexibility training needs. Results: The mean differences in change from baseline between the intervention groups and the waitlist group were not statistically significant for burnout outcomes: exhaustion (primary; individualized: -0.52, 95% CI -3.70 to 2.65, P=.75; nonindividualized: 1.60, 95% CI -1.84 to 5.03, P=.37), cynicism (individualized: -1.26, 95% CI -4.46 to 1.94, P=.44; nonindividualized: 1.00, 95% CI -2.45 to 4.46, P=.57), and academic efficacy (individualized: 0.94, 95% CI -0.90 to 2.79, P=.32; nonindividualized: 2.02, 95% CI 0.02-4.03, P=.05). Following the intervention, the individualized group demonstrated improved psychological flexibility (0.50, 95% CI 0.12-0.89; P=.01), reduced inflexibility (0.48, 95% CI -0.92 to -0.04; P=.04), and reduced stress (-6.89, 95% CI -12.01 to 5.99; P=.01), and the nonindividualized group demonstrated improved well-being (6.46, 95% CI 0.49-12.42; P=.04) and stress (-6.36, 95% CI -11.90 to -0.83; P=.03) compared with waitlist participants. Between-group differences for the individualized and nonindividualized arms were not statistically significant. High attrition (75/143, 52.4%) was observed. Conclusions: This trial provides early support for the potential benefits of Acceptance and Commitment Training for medical student well-being and psychological outcomes and demonstrates that psychological flexibility and inflexibility can be trained using a smartphone app. Although postintervention burnout outcomes were not statistically significant, improvements in secondary outcomes could indicate early risk mitigation. Replication studies with larger samples and longer-term follow-up are required, and future research should focus on improving implementation frameworks to increase engagement and optimize individualization methods. [ABSTRACT FROM AUTHOR]

Background: Physical inactivity is a risk factor for numerous adverse health conditions and outcomes, including all-cause mortality. Aging rural women are at particular risk for physical inactivity based on environmental, sociocultural, and psychosocial factors. This study reports on changes in physical activity and associated factors from a multicomponent community-engaged intervention trial. Methods: Strong Hearts, Healthy Communities 2.0 (SHHC-2.0) was a 24-week cluster (community) randomized controlled trial building on the results from the previous trial of SHHC-1.0. Rural women (n = 182) aged 40 and over living in 11 rural communities in upstate New York were recruited. The intervention consisted of twice-weekly experiential classes focused on exercise, nutrition, and civic engagement. Physical activity outcomes included accelerometry and self-report as well as related psychosocial measures at midpoint (12 weeks) and post-intervention (24 weeks). Data were analyzed using multilevel linear regression models with the community as the random effect. Results: Compared to participants from the control communities, participants in the intervention communities showed a significant increase in objectively measured moderate to vigorous intensity physical activity: at 12 weeks (increase of 8.1 min per day, P < 0.001) and at 24 weeks (increase of 6.4 min per day; P = 0.011). Self-reported total MET minutes per week also increased: at 12 weeks (increase of 725.8, P = 0.003) and 24 weeks (increase of 955.9, P = 0.002). Several of the psychosocial variables also showed significant positive changes. Conclusions: The SHHC-2.0 intervention successfully increased physical activity level and related outcome measures. Modifications made based upon in-depth process evaluation from SHHC-1.0 appear to have been effective in increasing physical activity in this at-risk population. Trial registration: Clinicaltrials.gov: NCT03059472. Registered 23 February 2017. [ABSTRACT FROM AUTHOR]

Background : Acute kidney injury (AKI) is a common complication after liver transplantation, which is associated with increased morbidity and mortality. Therefore, this study investigated mannitol as an oxygen-free radical scavenger and its role in the prevention of early AKI after living donor liver transplantation (LDLT). Methods : A total of 84 adult patients who underwent LDLT were randomly assigned to two equal groups: the M group, where patients received 1 g/kg mannitol 20%, or the S group, where patients received an equal volume of saline. The primary outcome was the incidence of early AKI, defined as a 0.3 mg/dl increase in the serum creatinine 48 h postoperatively. Laboratory assessments of the graft and creatinine were recorded until 3 months after transplantation besides the post-reperfusion syndrome and the intraoperative hemodynamic measurements. Results : The AKI incidence was comparable between groups (relative risk ratio of 1.285, 95% CI 0.598–2.759, P = 0.518). Moreover, AKI stages and serum creatinine 3 months after transplantation, P = 0.23 and P = 0.25, respectively. The incidence of the post-reperfusion syndrome was comparable in both groups, 29/39 (74.4%) and 31/41 (75.6%) in M and S groups, respectively, P = 0.897. The intraoperative hemodynamic parameters showed no significant difference between groups using the area under the curve. Conclusion : The current LDLT recipient sample was insufficient to demonstrate that pre-reperfusion 1 g/kg mannitol infusion would reduce the risk of early AKI or post-reperfusion syndrome. Clinical trial registration number : Pan African Clinical Trials Registry (PACTR202203622900599); https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=21511. [ABSTRACT FROM AUTHOR]

It is believed that clinical management of osteoarthritis should address muscle weakness to improve physical function and prevent disability and frailty This sub-study investigated the effects of supervised progressive resistance training (RT), supervised Nordic Walking (NW), and unsupervised home-based exercise (HBE) on muscle and functional performance; and associations between these exercise-induced changes in persons with hip osteoarthritis. Forty-two patients with hip osteoarthritis were recruited from a larger RCT (NCT01387867). All the groups (RT, n = 15; NW, n = 12; HBE, n = 15) exercised 1 h 3 times/week for 4 months. Quadriceps cross-sectional area (QCSA, MRI-determined); quadriceps strength (QMVC); leg extensor power (LEP); functional performance (chair stands (30sCS); stair climbs (TSC); and 6-minute walk (6MWT)) were assessed at baseline and 4 months. Per protocol analyses (one-way ANOVA and Bonferroni test) showed significant between-group differences for improvements in QCSA in the most symptomatic leg favoring RT versus NW (2.3 cm2, 95% CI [0.6, 3.9]) and HBE (2.3 cm2 [0.8, 3.9]); and 30sCS (1.8 repetitions [0.2–3.3]), and 6MWT (35.1 m [3.5–66.7]) favoring NW versus HBE. Associations existed between exercise-induced changes in QCSA and QMVC (r = 0.366, p =.019) for the most symptomatic leg and between changes in 6MWT and QMVC (r = 0.320, p =.04) and LEP (r = 0.381, p =.01), respectively, for the least symptomatic leg. Resistance training appeared effective for improving muscle mass, but less effective for improving muscle strength, power, and functional performance. Only exercise-induced changes in muscle strength and power of the least symptomatic leg, not the most symptomatic leg, were related to changes in functional performance. [ABSTRACT FROM AUTHOR]

Objective: To test the feasibility of a telephone delivered intervention, informed by cognitive behavioural principles, for post-stroke fatigue, and estimated its effect on fatigue and other outcomes. Design: Randomised controlled parallel group trial. Setting: Three Scottish stroke services. Subjects: Stroke survivors with fatigue three months to two years post-stroke onset. Interventions: Seven telephone calls (fortnightly then a 'booster session' at 16 weeks) of a manualised intervention, plus information about fatigue, versus information only. Main measures: Feasibility of trial methods, and collected outcome measures (fatigue, mood, anxiety, social participation, quality of life, return to work) just before randomisation, at the end of treatment (four months after randomisation) and at six months after randomisation. Results: Between October 2018 and January 2020, we invited 886 stroke survivors to participate in postal screening: 188/886 (21%) returned questionnaires and consented, of whom 76/188 (40%) were eligible and returned baseline forms; 64/76 (84%) returned six month follow-up questionnaires. Of the 39 allocated the intervention, 23 (59%) attended at least four sessions. At six months, there were no significant differences between the groups (adjusted mean differences in Fatigue Assessment Scale −0.619 (95% CI −4.9631, 3.694; p = 0.768), the Generalised Anxiety Disorder 7 −0.178 (95% CI −3.823, 3.467, p = 0.92), and the Patient Health Questionnaire −0.247 (95% CI −2.935, 2.442, p = 0.851). There were no between-group differences in quality of life, social participation or return to work. Conclusion: Patients can be recruited to a trial of this design. These data will inform the design of further trials in post-stroke fatigue. [ABSTRACT FROM AUTHOR]

Objective: WeiNaoKang (or SaiLuoTong) is an herbal formula consisting of ginkgo, ginseng, and saffron. Our objective was to investigate if WeiNaoKang could improve cognitive function and cerebral perfusion in patients suffering from vascular dementia. Methods: A 16‐week randomized double‐blind, placebo‐controlled trial was carried out in the setting of a memory disorder clinic at a single center. Patients with vascular dementia diagnosed clinically but supported by imaging and other investigations were invited to participate. The diagnoses were based on the National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS‐AIREN) criteria. An independent blinded assessor evaluated the effects of the formula. Intervention group was compared to the control group. A subgroup of participants was randomly chosen for further evaluation of cerebral perfusion by single photon emission computed tomography scans post‐treatment. Results: Both groups were comparable in age (mean = 74 ± 7.2 years in the placebo group and 75 ± 7.4 in the intervention group) and in other demographics. Sixty‐two participants were included in final analysis. Alzheimer's Disease Assessment Scale – Cognitive Portion (ADAS‐cog) was the primary outcome. By week 16, the mean ADAS‐cog reduced from 24.48 to 20.30 (mean reduction = 4.18) for those in the treatment group, and from 18.98 to 17.81 (mean reduction = 1.18) for those in the placebo group. The difference in mean reduction of ADAS‐cog was −3.00 (95% confidence interval [CI] = −4.910 to −1.100) in favor of the treatment group. Secondary outcomes of activities of daily living and quality of life measures also showed significant difference. In the perfusion scan analysis, the difference in the change in cerebral blood flow (t‐scores) pre‐ and post‐treatment between the intervention group (n = 7) and the placebo group (n = 11) was statistically significant (P < 0.001). Conclusion: In this randomized, double‐blind placebo‐controlled trial, we demonstrated significant differences in improvement in cognitive function and activities of daily living. The clinical improvement is corroborated with improvement in cerebral perfusion in a subset of participants. [ABSTRACT FROM AUTHOR]

Objective: To examine whether the combination of Naoxintong Capsule with standard care could further reduce the recurrence of ischemic stroke without increasing the risk of severe bleeding. Methods: A total of 23 Chinese medical centers participated in this trial. Adult patients with a history of ischemic stroke were randomly assigned in a 1:1 ratio using a block design to receive either Naoxintong Capsule (1.2 g orally, twice a day) or placebo in addition to standard care. The primary endpoint was recurrence of ischemic stroke within 2 years. Secondary outcomes included myocardial infarction, death due to recurrent ischemic stroke, and all-cause mortality. The safety of drugs was monitored. Results were analyzed using the intention-to-treat principle. Results: A total of 2,200 patients were enrolled from March 2015 to March 2016, of whom 143 and 158 in the Naoxintong and placebo groups were lost to follow-up, respectively. Compared with the placebo group, the recurrence rate of ischemic stroke within 2 years was significantly lower in the Naoxintong group [6.5% vs. 9.5%, hazard ratio (HR): 0.665, 95% confidence interval (CI): 0.492-0.899, P=0.008]. The two groups showed no significant differences in the secondary outcomes and safety, including rates of severe hemorrhage, cerebral hemorrhage and subarachnoid hemorrhage (P>0.05). Conclusion: The combination of Naoxintong Capsule with standard care reduced the 2-year stroke recurrence rate in patients with ischemic stroke without increasing the risk of severe hemorrhage in high-risk patients. (Trial registration No. NCT02334969) [ABSTRACT FROM AUTHOR]

Background Probiotics may alleviate lactose maldigestion. Objectives The objective was to select a probiotic with high lactase activity and compare it with lactase and placebo in clinical trials. Methods Bacterial cultures were screened for lactase activity in a model of the upper gastrointestinal (GI) tract. Bifidobacterium animalis subsp. lactis Bi-07 (Bi-07) counts were adjusted in subsequent experiments to correspond to 4500 Food Chemicals Codex (FCC) units of lactase, the amount in the European Food Safety Authority (EFSA)-approved health claim. Two crossover clinical trials, Booster Alpha and Booster Omega, were performed in participants with lactose intolerance, where 2 × 1012 CFUs Bi-07, 4662 FCC lactase, or placebo was consumed simultaneously with a lactose challenge, with 1-wk washouts between challenges. The trial designs were identical except for the source of lactose. Breath hydrogen concentration (BHC) was measured to assess the effect of the investigational products on lactose digestion, for which incremental area under the curve (iAUC) was the primary outcome. Peak BHC, cumulative BHC, and GI symptoms were secondary outcomes. Results Bi-07 was superior to placebo in reducing BHC [iAUC, parts per million (ppm) ∙ h] in both trials (Booster Alpha: geometric least square mean ratio: 0.462; 95% CI: 0.249, 0.859; P =  0.016; Booster Omega: 0.227; 95% CI: 0.095, 0.543; P  = 0.001). Lactase was superior to placebo in Booster Alpha (0.190; 95% CI: 0.102, 0.365; P  < 0.001) but not Booster Omega (0.493; 95% CI: 0.210, 1.156; P  = 0.102). Noninferiority of Bi-07 compared with lactase was observed in Booster Omega (0.460; 95% CI: 0.193, 1.096; P  = 0.079; CI upper limit < 1.25 noninferiority margin). Odds of abdominal pain (compared with placebo: 0.32, P  = 0.036) and flatulence (compared with placebo: 0.25, P  = 0.007) were lower with lactase in Booster Alpha. Increased odds of nausea were seen with Bi-07 (compared with placebo: 4.0, P  = 0.005) in Booster Omega. Conclusions Bi-07 has high lactase activit y , and in 2 clinical trials, it supported lactose digestion in individuals with lactose intolerance. These trials were registered at clinicaltrials.gov as NCT03659747 (Booster Alpha) and NCT03814668 (Booster Omega). [ABSTRACT FROM AUTHOR]

We assessed an intervention aimed at improving adherence to antiretroviral therapy (ART) among pregnant and postpartum women living with HIV (PPWLH). We randomized 133 pregnant women initiating ART in Uganda to receive text reminders generated by real time-enabled electronic monitors and data-informed counseling through 3 months postpartum (PPM3) or standard care. Intention-to-treat analyses found low adherence levels and no intervention impact. Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence. Additional analyses found significant adherence declines after delivery, and no effect on disease progression (CD4-cell count, viral load), though treatment interruptions were significantly fewer in intervention participants. Per-protocol analyses encompassing participants who used adherence monitors as designed experienced better outcomes, suggesting potential benefit for some PPWLH. The study was registered on ClinicalTrials.Gov (NCT02396394). [ABSTRACT FROM AUTHOR]

Objective: Specification of interventions and selection of controls are two methodological determinants for a successful acupuncture trial. However, current practice with respect to these two determinants is not fully understood. Thus, we conducted a cross-sectional survey to examine the specification of interventions and selection of controls among published randomized controlled trials (RCTs) of acupuncture. Study design and setting: We searched PubMed for acupuncture RCTs published in core clinical journals and complementary and alternative medicine (CAM) journals from January 2010 to December 2019 (10 years) and included RCTs that assessed treatment effects of acupuncture versus any type of control. We used network meta-analyses to explore whether there were differential treatment effects in patients with chronic pain when using sham acupuncture as a control versus using waiting list or no treatment. Results: Most of the 319 eligible RCTs specified well the style of acupuncture (86.8%), traditional acupuncture point locations (96.2%), type of needle stimulation (90.3%) and needle retention time (85.6%). However, other acupuncture details were less-frequently specified, including response sought (65.5%), needle manipulation (50.5%), number of needle insertions (21.9%), angle and direction of insertion (31.3%), patient posture (32.3%) and co-interventions (22.9%). Sham acupuncture (41.4%) was the most frequently used control, followed by waiting list or no treatment (32.9%). There was no differential treatment effect when using sham acupuncture versus waiting list/no treatment as a control (standardized mean difference = −0.15, 95% confidence interval: −0.91 to 0.62). Conclusion: Over a decade of research practice, important gaps have remained in the specification of acupuncture interventions, including response sought, needle manipulation, and co-interventions. While sham acupuncture has been widely used, waiting list or no treatment may also be considered as an appropriate control. [ABSTRACT FROM AUTHOR]

This study examined whether an emotion regulation toolkit of reappraisal, mindfulness, and savoring exercises could promote well-being and train cognitive reappraisal skill over and above an active control toolkit. University students were randomly assigned to the well-being toolkit intervention (n = 39), or one of two active control conditions that involved cognitive activity exercises (breathing and memory recall exercises) found to be ineffective in promoting well-being over and above intervention conditions in past research. The well-being toolkit control (n = 41) was presented to participants as an ostensible "Mental Wellbeing Toolkit" to increase expectancy beliefs. The cognitive toolkit control (n = 39) included the same cognitive activity exercises as the well-being toolkit control, but was presented to participants as a neutral "Cognitive Activity Toolkit." Participants were instructed to complete 10 days of surveys and practice at least one exercise from their toolkit per day. Results from 1,133 data points showed declines across all conditions in stress and negative affect and increases in positive affect over 10 days. This finding points to a potential beneficial effect of intentionally engaging in activities involving some form of self-referential reflection--the underlying commonality across activities in all conditions--irrespective of whether individuals are instructed to engage in emotion regulation or not. However, compared with both control conditions, the intervention led to sharper growth in daily cognitive reappraisal over 10 days of practice, suggesting the intervention's advantage of developing the foundational emotion regulation strategy of cognitive reappraisal. [ABSTRACT FROM AUTHOR]

While there is a large body of evidence drawn from randomised controlled trials supporting the efficacy of SSGT in autistic adolescents, the control arms of these studies are almost exclusively treated either as usual or waitlist. Addressing this limitation, 90 verbal autistic adolescents (70% male) aged 12–17 years (M = 13.77, SD = 1.6) with IQ > 70 participated in this pragmatic two-armed randomised controlled trial design study evaluating the efficacy of sixteen 90-min sessions of SSGT KONTAKT® (n = 46) in comparison to a manualised interactive group cooking programme (n = 44) of equal dosage controlling for the potentially confounding effects of exposure to a social group context. The primary outcome was the adolescents' progress towards achieving their personally meaningful social goals at follow-up. Secondary outcomes were changes in autistic traits, quality of life, facial emotion recognition skills, social anxiety, and loneliness. Assessments were conducted at baseline, post intervention and 12-week follow-up. The interaction between time point and group allocation was investigated through a random-effects regression model (linear mixed model) to examine changes in the dependent outcomes. While intention-to-treat analysis (N = 90) demonstrated that both SSGT (ES = 1.36, p <.001) and active control (ES = 1.10, p <.001) groups made progress towards their personally meaningful social goals at follow-up, KONTAKT® participants demonstrated greater progress in social goal attainment than their peers in the active control group (ES = 0.35, p =.04). Findings suggest that KONTAKT® is efficacious in supporting autistic adolescents to achieve their personally meaningful social goals compared to other prosocial group activities. Trial registration: (1) Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12617001117303, registered 31 July 2017, anzctr.org.au; (2) ClinicalTrials.gov: NCT03294668 registered 22 September 2017, https://clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

The current study aimed to explore the impact of a school-based mindfulness intervention on bullying behaviors among teenagers. A cluster randomized controlled trial was conducted, in which the experimental group (n = 92) received mindfulness intervention, and the control group (n = 97) did not. The measured outcomes included: bullying behavior, self-control, and trait mindfulness. The results were as follows: (1) the post-test scores of trait mindfulness and self-control in the experimental group significantly increased (p < 0.01) while the scores of bullying behavior significantly decreased (p < 0.01); (2) trait mindfulness was positively associated with self-control (r = 0.13 to 0.63, p < 0.05), whereas trait mindfulness and self-control were both negatively associated with bullying behavior (r = −0.38 to −0.13, p < 0.05); and (3) the mediating effect of self-control accounted for 50% of the overall effect of trait mindfulness on bullying behavior. These findings demonstrated that the school-based mindfulness intervention distinctly improves trait mindfulness and self-control and reduces bullying behavior among teenagers. Moreover, self-control plays a mediating role between trait mindfulness and bullying behavior. [ABSTRACT FROM AUTHOR]

Children with chronic illness (CI) are at risk for internalizing problems, which reduce their quality of life, hamper treatment, and increase family stress. Accordingly, behavioral interventions are provided at the family level. However, the effects of parental involvement on child outcomes are not consistently beneficial. Therefore, it is relevant to study the working mechanisms. In the present study, we tested child coping and parenting stress as underlying mechanisms of the effect of an intervention for children and an additional group intervention for parents. Data were analyzed from a randomized controlled trial. Families of children with chronic illness (N = 120, child M age = 12.11 years, range 7.98–18.07) participated in a cognitive-behavioral-based group intervention and were randomized in the child-only intervention or parent–child intervention. Primary outcomes were parent- and child-reported internalizing problems, whereas the mediators were the use of child active coping skills and parenting stress. The causal model was tested with multilevel mediation analysis. Active coping skills and parenting stress stood out as significant mediators of the effect of the intervention on parent- and child-reported internalizing behavior (Cohen's d effect size range 0.29–1.57). When parents were involved in the intervention, children increased their use of active coping skills and parents decreased in parenting stress, which in turn improved child internalizing problems. Knowing that coping skills and parenting stress underlie the benefit of involving parents can be used for optimizing interventions for children with CI and addressing the risk of internalizing problems. Highlights: Parental involvement in interventions for children with chronic illness can be beneficial, however explanations are still unclear. In this randomized efficacy trial, child use of active coping skills and parenting stress appeared significant temporal mediators. Parental involvement supported child coping and diminished parenting stress, which in turn decreased child internalizing problems. Interventions for children with internalizing problems might be optimized by focusing on determined active components. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of Bushen Huoxue Formula (BSHXF) for the treatment of discogenic low-back pain (DLBP). Methods: This was a parallel, double-blind, randomized, clinical trial performed between May 2019 and June 2020. Seventy patients were assigned by computerized random number table to the treatment group (lumbar traction and BSHXF, 35 cases) or the control group (lumbar traction and placebo, 35 cases). The patients received intervention for 3 weeks. Assessment was conducted before treatment and at week 1, 2, 3 during treatment. Primary outcome was the self-reported score of Oswestry Disability Index (ODI). Secondary outcomes included Visual Analog Scale (VAS), clinical efficacy rate by minimal clinically important difference (MCID) as well as lumbar tenderness, muscle tone and lumbar spine mobility. Adverse reactions were recorded. Follow-up was performed at 1 and 3 months after the end of treatment. Results: In the treatment group, ODI score was significantly decreased compared with baseline (P<0.05) and the control group at 2- and 3- week treatment. Similarly, VAS score decreased compared with the baseline (P<0.05) and was lower than that in the control group at 2- and 3- week treatment (P<0.05). The clinical efficacy rate of the treatment group was higher than that of the control group after treatment [32.35% (11/34) vs. 3.13% (1/32), P<0.05). Moreover, the tenderness, and muscle tone, as well as the back extension and left flexion in lumbar spine mobility in the treatment group at 3-week treatment were significantly improved compared with the control group (P<0.05). Follow-up showed that at 1-month after treatment, the treatment group had better outcomes than the control group with regard to a total score of ODI and VAS scores, as well as clinical efficacy rate (all P<0.05). Moreover, VAS score was still significantly lower than the control group at 3-month follow-up (P<0.05). No adverse reactions were reported during the study. Conclusion: BSXHF combined with lumbar traction can significantly improve the clinical symptoms including pain intensity, functionality, muscle tone, and lumbar spine mobility in DLBP patients. (Registration No. ChiCTR1900027777). [ABSTRACT FROM AUTHOR]

Collaborations with traditional healers have been proposed to improve HIV testing uptake. We hypothesized that healer-delivered HIV testing would improve HIV testing uptake, compared with referral to clinic-based HIV testing. We conducted a cluster randomized trial to determine the effectiveness of traditional healers delivering counseling and HIV testing in Mwanza, Tanzania (ClinicalTrials.gov NCT#04071873). Intervention arm healers provided counseling and offered point-of-care HIV tests to adult clients of unknown HIV serostatus. Control arm healers provided referral for clinic-based testing. Primary outcome was receipt of an HIV test within 90 days of enrollment. Secondary outcomes were new HIV diagnosis and linkage to care. In the intervention, 100 clients (100%) received an HIV test, compared with 73 (73%) of control participants (p < 0.001). Two intervention arm participants (2%) had a new diagnosis compared with zero in the control arm (p = 0.50). Engaging traditional healers might provide a culturally concordant opportunity to improve HIV testing uptake. [ABSTRACT FROM AUTHOR]

Background: Sterile water injections can provide effective pain relief during childbirth, particularly for low back pain related to childbirth. However, the pain associated administering the injections can negatively impact women's impressions of the procedure. It may discourage women from considering repeat doses despite the quality of analgesia experienced. Determining strategies to reduce the pain related to the administration of sterile water injections would improve the acceptability of the technique. Therefore, the aim of this study was to evaluate the effect of topical local anesthesia on the pain associated with administration of sterile water injections. Methods: The study was designed as a multi-arm single-blind, randomized, controlled trial and 120 female healthy students were randomly divided according to one of four groups. The Intervention group received sterile water injections with topical local anesthesia. Control group 1 received sterile water injections without topical local anesthesia, control group 2 received injections of isotonic saline 0.9% with topical local anesthesia and control group 3 received injections of isotonic saline 0.9% without topical local anesthesia. Pain Immediately after the injections and subsidence in pain were recorded using a visual analogue scale. Sensations in the injection area were reported 15 min and the day after the injections. Results: The main finding of this study was that local anesthesia with EMLA® reduces the pain associated with the administration of intracutaneous sterile water injections. There was a significant difference in the self-assessed pain score immediately following the injections between the control (73.3 mm) and intervention groups (50.0 mm), p = 0.001. No adverse side effects were reported. Conclusion: Local anesthesia with EMLA® reduces the pain associated with intracutaneous administration of sterile water injections. Trial registration: The study was registered 08/07/2014 at ClinicalTrials.gov Identifier: NCT02213185. [ABSTRACT FROM AUTHOR]

Lactational breast abscess results from inadequate or partially treated mastitis. Recently, needle aspiration or catheter suction drainage is being adopted in place of incision and drainage. We planned to evaluate the effectiveness of needle aspiration versus vacuum suction drainage in resolution of puerperal breast abscess. One-hundred-twelve mothers with lactational breast abscess were randomized to either ultrasound-guided needle aspiration or vacuum suction drainage. These patients were followed up on alternate days and assessed for complete resolution of breast abscess, pain in the breast on Visual Analog Scale (VAS) of 0–10, day of return to normal breast feeding, number of aspirations needed, recurrence of abscess and total cost of care. In the suction drain group, 98% of mothers enjoyed complete resolution within 10 days as compared to 87% of mothers treated with needle aspiration. Mean VAS at first follow-up was 2.89 in aspiration group and 2.62 in suction group. The VAS reduced to 0.74 in aspiration group and 0.53 in suction drainage group, at the last follow-up. The mean day of recovery was 7 days for aspiration and 5.73 days for suction. Most patients required 3 aspirations. The mean drainage time was 4.5 days. Vacuum suction drainage is the more effective method for achieving resolution of lactational breast abscess and offers greater patient satisfaction compared to needle aspiration. [ABSTRACT FROM AUTHOR]

Purpose: We examined the effectiveness of the "positive diary," in which family caregivers of people with dementia write down three good things that happened with reasons at the end of each day. Design and Methods: In this randomized controlled trial, the intervention group used the "positive diary," while the control group kept a record of each meal for 4 weeks. Findings: The intervention group showed improvement on several measures of wellbeing including Neuropsychiatric Inventory Questionnaire and Center for Epidemiologic Studies Depression Scale. Practice Implications: The "positive diary" is a useful self‐care tool for caregivers of people with dementia. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to examine the effects of a psychoeducational program on the cognitive emotion regulation levels of individuals with multiple sclerosis (MS). Design and Method: This study followed a randomized, controlled quasi‐experimental design. A questionnaire including descriptive characteristics and disease‐related characteristics and the Cognitive Emotion Regulation Questionnaire were used in the data collection. Findings: The difference between the pretest–posttest and follow‐up test mean scores of the patients in the experimental group was significant (p < 0.05). Conclusion: The psychoeducation program based on the rational emotional behavioral approach increased the use of cognitive emotion regulation strategies in individuals with MS. [ABSTRACT FROM AUTHOR]

To investigate the efficacy of a tailored counselling intervention for injured workers regarding different aspects of subjective well-being. Prospective randomized controlled trial with 192 mildly-to-moderately injured workers who were on sick leave for at least 18 weeks and showed a high-risk profile for a complicated rehabilitation process in a screening. Patients were assessed at baseline, 12 and 18 months post-injury. The outcome variables concerned five aspects of subjective well-being (negative feelings, life and job satisfaction, satisfaction related to family and health). Both the control and the experimental group received conventional case management. Participants in the intervention group additionally received tailored workplace interventions and/or mental health counselling sessions. Participants in the intervention group received an average of 2.23 (SD = 6.94) counselling sessions. Both groups showed a significant reduction (mean (95% CI) of negative feelings control group 2.6 (2.3–3.4), intervention group 2.4 (1.6–3.4)), with a significant difference in negative feelings between the groups (p = 0.01). Our results suggest that a tailored counselling intervention has a modest long-term effect (d = 0.74) on negative feelings for mildly-to-moderately injured workers. However, future studies should evaluate the feasibility of this study's treatment approach. Accidents and the resulting injuries often cause a wide range of burdens including psychosocial and emotional distress as well as long-time sick leaves. Tailored counselling led to significant reductions of negative feelings in mildly-to-moderately injured workers over time. By showing that even conventional case management can have a beneficial effect on subjective wellbeing, the results of this study reaffirm the holistic biopsychosocial nature of injury rehabilitation. [ABSTRACT FROM AUTHOR]

Objective: Many individuals with an eating disorder do not receive appropriate care. Low‐threshold interventions could help bridge this treatment gap. The study aim was to evaluate the effectiveness of Featback, a fully automated online self‐help intervention, online expert‐patient support and their combination. Method: A randomized controlled trial with a 12‐month follow‐up period was conducted. Participants aged 16 or older with at least mild eating disorder symptoms were randomized to four conditions: (1) Featback, a fully automated online self‐help intervention, (2) chat or email support from a recovered expert patient, (3) Featback with expert‐patient support and (4) a waiting list control condition. The intervention period was 8 weeks and there was a total of six online assessments. The main outcome constituted reduction of eating disorder symptoms over time. Results: Three hundred fifty five participants, of whom 43% had never received eating disorder treatment, were randomized. The three active interventions were superior to a waitlist in reducing eating disorder symptoms (d = −0.38), with no significant difference in effectiveness between the three interventions. Participants in conditions with expert‐patient support were more satisfied with the intervention. Discussion: Internet‐based self‐help, expert‐patient support and their combination were effective in reducing eating disorder symptoms compared to a waiting list control condition. Guidance improved satisfaction with the internet intervention but not its effectiveness. Low‐threshold interventions such as Featback and expert‐patient support can reduce eating disorder symptoms and reach the large group of underserved individuals, complementing existing forms of eating disorder treatment. Public significance statement: Individuals with eating‐related problems who received (1) a fully automated internet‐based intervention, (2) chat and e‐mail support by a recovered individual or (3) their combination, experienced stronger reductions in eating disorder symptoms than those who received (4) usual care. Such brief and easy‐access interventions play an important role in reaching individuals who are currently not reached by other forms of treatment. [ABSTRACT FROM AUTHOR]

Background: Transdiagnostic group cognitive-behavioral therapy (tCBT) is a delivery model that could help overcome barriers to large-scale implementation of evidence-based psychotherapy for anxiety disorders. The aim of this study was to assess the effectiveness of combining group tCBT with treatment-as-usual (TAU), compared to TAU, for the treatment of anxiety disorders in community-based mental health care. Methods: In a multicenter single-blind, two-arm pragmatic superiority randomized trial, we recruited participants aged 18–65 who met DSM-5 criteria for principal diagnoses of generalized anxiety disorder, social anxiety disorder, panic disorder, or agoraphobia. Group tCBT consisted of 12 weekly 2 h sessions. There were no restrictions for TAU. The primary outcome measures were the Beck Anxiety Inventory (BAI) and clinician severity rating from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) for the principal anxiety disorder at post-treatment, with intention-to-treat analysis. Results: A total of 231 participants were randomized to either tCBT + TAU (117) or TAU (114), with outcome data available for, respectively, 95 and 106. Results of the mixed-effects regression models showed superior improvement at post-treatment for participants in tCBT + TAU, compared to TAU, for BAI [ p < 0.001; unadjusted post-treatment mean (s.d.): 13.20 (9.13) v. 20.85 (10.96), Cohen's d = 0.76] and ADIS-5 [ p < 0.001; 3.27 (2.19) v. 4.93 (2.00), Cohen's d = 0.79]. Conclusions: Our findings suggest that the addition of group tCBT into usual care can reduce symptom severity in patients with anxiety disorders, and support tCBT dissemination in routine community-based care. [ABSTRACT FROM AUTHOR]

Objective: Sleep disturbance is one of the most prevalent problems in post-menopausal females. The current research intended to evaluate the effects of Dracocephalum on sleep disorder in post-menopausal females. Method: The current study is a randomized, double-blind controlled trial, in which 110 post-menopausal women were randomly allocated to Dracocephalum or placebo groups. The intervention group took Dracocephalum capsules containing 250 mg Dracocephalum extract twice daily for one month. While, the placebo group took the same capsule containing 250 mg of starch twice daily for one month. Pittsburgh Sleep Quality Index was completed by the participants of both groups before and after the treatment and the data obtained were analyzed with Chi-square, paired and independent t-test in SPSS (version 20). Results: The mean score of sleep quality before and after the treatment was 12.69 ± 3.98 and 8.58 ± 1.97 in the treatment group, respectively. Also, the score of sleep quality in the placebo group was 13.48 ± 2.60 and 11.21 ± 2.74 at the beginning and end of the research, respectively. The symptoms of sleep disorder in the intervention group significantly improved after the treatment (P < 0.001), while this was not the case with the placebo group (P = 0.155). Besides, there was a significant difference between the two groups in the mean score of sleep quality after the treatment (P = 0.012). Conclusion: Dracocephalum extracts are effective in reducing symptoms of sleep disorders in post-menopausal women. [ABSTRACT FROM AUTHOR]