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BACKGROUND: More than 1,000 randomized controlled trials have been published examining the effectiveness of stroke rehabilitation interventions. OBJECTIVE: The objective of this study was to explore the use and non-use of evidence-based stroke rehabilitation interventions in clinical practice among Occupational Therapists across various stroke rehabilitation settings in Canada. METHODS: Participants were recruited from medical centres providing rehabilitation to stroke patients in each of the ten provinces across Canada (January-July 2021). Adult (18 + years) Occupational Therapists who provide direct rehabilitative care to individuals after a stroke completed a survey in either English or French. Therapists rated their awareness, use, and reasons for non-use of stroke rehabilitation interventions. RESULTS: 127 therapists (female = 89.8%), largely from Ontario or Quebec (62.2%) were included; most worked full-time (80.3%) in moderate-large (86.1%) cities. The greatest use of interventions were those applied to the body peripherally, without a technological component. Few individuals were aware of interventions applied to the brain (priming or stimulating) with a technological component, and they were rarely, if ever, used. CONCLUSION: Significant efforts should be made to increase the awareness of interventions which are supported by strong evidence through knowledge translation and implementation initiatives, particularly for those with a technological component. [ABSTRACT FROM AUTHOR]

Context: In many societies, although chronic low back pain (LBP) is a significant problem, there is no consensus on the optimal therapeutic intervention. Objective: To compare the impact of aquatic exercise (AE) and kinesio taping (KT) on the pain intensity and functional incapacity in women with chronic nonspecific LBP. Design: Randomized controlled trial. Setting: Outpatient clinic. Participants: Thirty-six women with chronic nonspecific LBP (mean [SD]: age = 50.69 [4.187] y) participated. Interventions: Participants randomly assigned to AE (n = 12), KT (n = 12), and nontreatment control (n = 12) groups for 6 weeks. Main outcome measures: Pain intensity and functional disability were evaluated at baseline and the end of the intervention. Results: Pain intensity decreased more in the AE group than in the KT group (5.9-0.5 cm [91.6% decrease] vs 5.7-2.4 cm [58.1% decrease], respectively; P < .001 for both after Bonferroni post hoc test); the values decreased more in the 2 treatment groups than in the control group (P < .001 for between-group comparisons). Disability decreased more in the AE group (43.2%-18.8% [55.6% decrease]) than the KT group (37.8%-19.3% [48.3% decrease]) (P < .001 for both comparisons), but increased in the control group (38.7%-41.2% [6.5% increase]; P = .045). Conclusion: These results suggest AE and KT treatment methods provide pain intensity and disability improvements in women with chronic nonspecific LBP. Nevertheless, AE was more effective than KT. [ABSTRACT FROM AUTHOR]

Background: There are relatively few studies to address mental health implications of self-affirming, especially across groups experiencing a chronic health condition. In this study, short- and longer-term effects of a brief self-affirmation intervention framed in terms of implementation intentions (if-then plans with self-affirming cognitions; S-AII) were evaluated against an active control group (non-affirming implementation intentions; N-AII), matched to the target condition, and mere goal intention condition (a non-active control) in adults with psoriasis. The three pre-registered primary outcomes captured depression, anxiety, and well-being. Methods: Adults with psoriasis (N = 175; M age = 36.53, s.d. = 11.52) were randomized into S-AII, N-AII, or control. Participants' mental health outcomes were assessed prior to randomization (at baseline), at week 2 (post-intervention), and at a 1-month follow-up. Results: Linear mixed models were used and results were reported on the intention-to-treat principle. Analyses revealed that S-AII exerted significantly more improvement in the course of well-being (d s > 0.25), depressive symptoms (d s > −0.40), and anxiety (d s > −0.45) than the N-AII and control group at 2-week post-intervention. Though the differences between groups faded at 1-month follow-up, the within-group changes over time for S-AII in all mental health outcomes remained significant. Conclusions: Brief and low-intensity S-AII intervention exerted in the short-term a considerable impact on mental health outcomes. The S-AII shows promising results as a relevant public mental health strategy for enhancing well-being and reducing psychological distress. Future studies could consider whether these effects can be further enhanced with booster interventions. [ABSTRACT FROM AUTHOR]

Objective: Schizophrenia is known as a severe psychiatric disorder with a broad range of clinical indications and symptoms such as positive and negative symptoms. This study was conducted with the aim of investigating the effect of melatonin on positive and negative symptoms of inpatients with schizophrenia. Method: This study was conducted as a randomized placebo-controlled trial (double-blind) in the population of patients with schizophrenia. Study samples were selected from inpatients with schizophrenia, according to the DSM-5 criteria, who had not been diagnosed with a depressive episode of schizophrenia based on the Calgary questionnaire and who also met the inclusion criteria. 46 patients with schizophrenia were randomly assigned to the intervention (6 mg melatonin per day as two 3 mg pills for six weeks) and placebo groups. The positive and negative symptom scale (PANSS) was used to assess the effect of treatment at T1 (before intervention), T2 (three weeks after beginning the intervention) and T3 (six weeks after beginning the intervention). To check the research hypotheses, multiple comparison statistics were used by the SPSS 22 software. Results: The placebo and melatonin groups had no significant difference in terms of PANSS scores (negative, positive, general and total symptom scores) at T1. Also, there was no difference in PANSS scores between the two groups at T2. However, at T3, there was a significant difference between the two groups only in the score of negative symptoms of PANSS (P = 0.036), so that negative symptoms of schizophrenia were significantly reduced in the intervention group compared to the placebo group. Furthermore, based on within-group analyzes, all PANSS scores were significantly reduced in the two groups at T2 and T3 (P < 0.05). Conclusion: Long-term use (at least six weeks) of melatonin can improve the negative symptoms of schizophrenia. Since antipsychotics can better affect the positive symptoms, the use of melatonin in combination with these drugs may perhaps further improve the patients' symptoms. [ABSTRACT FROM AUTHOR]

People living with HIV (PLHIV) need lifelong medical care. However, retention in HIV care is not measured uniformly, making it challenging to compare or pool data. The objective of this study within a review (SWAR) is to describe the assortment of definitions used for retention in HIV care in randomized controlled trials (RCTs). We conducted a SWAR, drawing data from an overview of systematic reviews on interventions to improve the HIV care cascade. Ethics review was not required for this analysis of secondary data. We identified RCTs of interventions used to improve retention in care for PLHIV, including all age groups and extracted the definitions used and their characteristics. We identified 50 trials that measured retention published between 2007 and 2021 and provided 59 definitions for retention in care. The definitions consisted of nine different characteristics with follow-up time (n = 47), and clinical visits (n = 36) most used. The definitions of retention in HIV care are highly heterogeneous. In this study, we present the pros and cons of characteristics used to measure retention in HIV care. [ABSTRACT FROM AUTHOR]

This randomized trial compared the first online parent training program for an evidence-supported executive function intervention for autism to in-person parent training with the same dose and content. Parents of autistic children (8–12 years-old; Full Scale IQ above 70) were randomized to in-person (n = 51) or online (n = 46) training. Training acceptability and feasibility were rated highly by parents, without significant differences between groups. The completion rate was lower for parents in the online versus the in-person training condition, but neither the total time spent with training materials, nor parent and child outcomes differed by condition. Parents reported that training resulted in a reduction in caregiver strain (Cohen's d = 0.66) and modest improvements in child flexibility, emotional control and global EF, but not planning and organization. Dose of parent training had a significant positive effect on child planning and organization problems. These findings did not support the hypothesized superiority of online to in-person training, but they did indicate online is as effective as in-person training at helping parents learn to improve their autistic children's EF abilities and reduce their own experience of parenting strain. Implications included increased access to training for parents who experience barriers to receiving in-person care. Trial Registration: clinicaltrials.gov Identifier: NCT02708069 This study compared the first online parent training program for executive function intervention for autism to in-person parent training on the same content. Participants were parents of autistic children, who were between 8 and 12 years of age and did not have intellectual disability. Parents were randomized to the in-person (n = 51) or online (n = 46) training conditions. Both trainings were developed with stakeholder (parents and autistic people) guidance. In this trial, most parents reported that they liked both trainings and that they were able to implement what they learned with their children. Parents in both groups spent equivalent amounts of time (about 8 hours) with the training materials, but while 94% of parents in the in-person training attended both parent trainings, only 59% of parents in the online group completed all 10 online modules. Parents reported that it was difficult to stay motivated to complete the online trainings over the 10-week trial. Parent and child outcomes did not differ significantly between the groups. Overall, parents reported that the trainings resulted in a reduction in their own parenting strain and improvements in their child's flexibility, emotional control, and global executive function, but not planning and organization. These findings indicated brief in-person and online training can help parents learn to support and improve their autistic children's executive function abilities, reducing their own experience of parenting strain. The finding that the online training was equivalent to the in-person trainings is important because it is accessible to parents who encounter barriers to in-person care. [ABSTRACT FROM AUTHOR]

Children with low performance in early numeracy are at risk of facing learning difficulties in mathematics, but few trials have examined how this can be ameliorated. A total of 120 first-grade children (Mage = 6.4 years) were randomly assigned to an intervention or a control condition. The 14-week intervention targeted early numeracy skills and was delivered in small groups three times a week. Immediately after the initial 8-week intervention phase, moderate and positive effects were found on early numeracy (d = 0.19), word problem solving (d = 0.41), and approximate number sense (d = 0.35). However, only the effects on word problems were significant, and all effects disappeared after the children undertook a second 6-week intervention phase. Overall, results indicate that (a) early numeracy skills are malleable in low-performing children, but (b) frequent and long-term interventions are needed for the positive effects to last. [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]

Background: The intermediate- and long-term effects of regular low-dose sustained-release (SR) morphine on the testosterone levels of people with persistent breathlessness are unknown. Methods: Exploratory analysis of a randomized controlled trial of the effects of regular SR morphine (0/8/16/24 mg every 24 hours) for persistent breathlessness associated with chronic obstructive pulmonary disease. Total testosterone was measured at baseline and at cessation (greater than or equal to three months on stable medication). Results: Among 20 participants (9 males; median treatment duration between measurements 169 days [IQR 162–175]), only 3 had substantial declines in testosterone levels during the study (morphine 8, 16, 24 mg groups). All three had worsening illness at the time of the second assessment. There was no apparent relationship between change in testosterone, morphine dose, and change in breathlessness. Conclusions: Substantial declines in testosterone were uncommon and were not apparently related to changes in morphine dose or breathlessness, but they were possibly related with worsening illness. [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]

Background: Explicit Sensory Retraining (SR) has been suggested for pain management in several neuropathic pain syndromes. Objectives: To study the effectiveness of SR on Central Post Stroke Pain (CPSP) symptoms. Methods: A preplanned subgroup of 23 subjects post-stroke reporting central pain were randomized within a larger study, to receive either explicit sensory discrimination retraining (SR) (in subgroup n = 11) or implicit repeated exposure to stimuli (RE) (in subgroup n = 12), applied to the lower limb. Pain intensity measured by VAS, measures of sensory ability; balance and gait activities; and participation were assessed by a blinded assessor at four points in time. Results: A group*time interaction effect was demonstrated (p = 0.04) for VAS, as for the SR treatment group VAS decreased from 56/100 to 23/100. Nine out of eleven subjects in the SR group demonstrated positive response to treatment. Pain alleviation was maintained at follow-up. A similar interaction effect was found for tactile threshold (p = 0.03). Significant improvement was noted for all other variables with no group differences. Conclusion: This study provides preliminary evidence to the clinically relevant positive effect of explicit sensory retraining for subjects with CPSP. The positive effect on tactile threshold detection could potentially indicate pain alleviation mechanisms. [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: Wrist-ankle acupuncture (WAA) has been reported in the treatment of acute pain in orthopedic surgery. However, the effects of WAA on acute pain were controversial in the current studies. Therefore, the purpose of this meta-analysis was to critically evaluate the effects of WAA on acute pain in orthopedic surgery. Methods: Several digital databases were searched from the inception of databases to July 2021, including CNKI, VIP, Wanfang, CBM, Pubmed, Cochrane Central Register of Controlled Trials, Embase, Medline, and Web of Science Core Collection. The risk of bias was evaluated using the Cochrane collaboration criteria. The primary outcome indicators included pain score, pain killer dosage, analgesia satisfaction, and adverse reaction incidence. All analyses were performed with Review Manager 5.4.1. Result: A total of 10 studies with 725 patients with orthopedic surgery (intervention group: 361, control group: 364) were included in this meta-analysis. The results demonstrated that the pain score of the intervention group was lower than the control group, and the difference was statistically significant [MD = − 0.29, 95%CI (− 0.37, − 0.21), P < 0.0001]. Compared with the control group, the patient in the intervention group used smaller amounts of pain killer [MD = − 0.16, 95%CI (− 0.30, − 0.02), P = 0.02]. The satisfaction of patients on pain relief was also higher in the intervention group, and the difference was statistically [OR = 0.25, 95%CI (0.15,0.41), P < 0.0001]. Conclusion: WAA has a certain effect on acute pain in orthopedic surgery, and the effect of WAA combined with other therapies is better than that of not using WAA therapy. [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]

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]

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]

Purpose: This study aimed at evaluating the effectiveness of a nutritional counselling intervention based on encouraging the consumption of unprocessed and minimally processed foods, rather than ultra-processed products, and the practice of physical activities to prevent excessive gestational weight gain in overweight pregnant women. Methods: This was a two-armed, parallel, randomized controlled trial conducted in primary health units of a Brazilian municipality from 2018 to 2021. Overweight, adult pregnant women (n = 350) were randomly assigned to control (CG) or intervention groups (IG). The intervention consisted of three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods rather than ultra-processed products, following the NOVA food classification system, and the practice of physical activities. The primary outcome was the proportion of women whose weekly gestational weight gain (GWG) exceeded the Institute of Medicine guidelines. Adjusted logistic regression models were employed. Results: Complete data on weight gain were available for 121 women of the IG and 139 of the CG. In modified intention-to-treat analysis, there was a lower chance of the IG women having excessive GWG [OR 0.56 (95% CI 0.32, 0.98), p =.04], when compared to the CG. No between-group differences were observed for the other maternal outcomes investigated. Conclusion: The present study was unprecedented in demonstrating that nutritional counselling based on the NOVA food classification system, together with encouraging the practice of physical activity, is effective in preventing excessive weight gain in overweight pregnant women. Trial registration: Registered on July 30th 2018 at Brazilian Registry of Clinical Trials (RBR-2w9bhc). [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: 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]

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]

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]

Objective: This study investigated the efficacy of extracorporeal shock wave therapy as well as the optimal intervention timing for extracorporeal shock wave therapy for patients with spasticity after stroke. Design: A search of randomized controlled trials was conducted in different electronic databases. We performed a meta-analysis to measure the effect of extracorporeal shock wave therapy versus sham interventions on spasticity and limb functionality. The meta-regression analysis was performed to determine the adequate intervention timing of extracorporeal shock wave therapy. The follow-up period of the outcomes was divided into the short (<2 wks), mid (>2 wks and ≤4 wks), and long (>4 wks and ≤3 mos) terms. Results: Thirteen studies with 677 participants were evaluated. Spasticity significantly improved throughout the follow-up duration. Limb functionality significantly improved in the short-term follow-up period. The meta-regression analysis showed that patients with stroke duration less than 45 mos may be benefited from extracorporeal shock wave therapy in improving limb function in all follow-up periods. Conclusions: Extracorporeal shock wave therapy is an effective method for reducing spasticity in patients with stroke, and the effect could be maintained for up to 3 mos. Its effects on limb functionality could persist for at least 2 wks. Patients who had stroke for less than 45 mos may have significant benefit from extracorporeal shock wave therapy in all follow-up periods. [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]

This systematic review and meta-analysis aimed to evaluate changes in resting blood pressure (RBP) with differences in regular resistance training (RT) programs. Inclusion criteria were randomized controlled trials involving hypertensive adults and interventions involving only RT of both the upper and lower limbs for ≥7 weeks. The weighted mean difference (WMD) was defined as the mean difference between the exercise and control groups, weighted by the inverse of the squared standard error for each study, and all WMDs in RBP were pooled as overall effects. A simple meta-regression analysis was performed to evaluate the relationship between RT variables (percentage 1 repetition maximum [1RM], number of repetitions, number of sets, and weekly frequency) and changes in RBP. Seventeen studies (646 subjects) were analyzed. The pooled WMDs in the resting systolic blood pressure (RSBP) and resting diastolic blood pressure (RDBP) decreased significantly but contained significant heterogeneity {RSBP, -4.7 mm Hg (95% confidence interval [CI], -6.7 to -2.8; I² = 46.6%); RDBP, -3.5 mm Hg (95% CI, -4.9 to -2.1; I² = 39.1%)}. Meta-regression analysis revealed that an increase in % 1RM was significantly associated with a decrease in the RSBP (γ = -0.25x0 + 10.85, where γ represents the mean difference in RSBP, and x0 represents % 1RM [%]), and heterogeneity was alleviated (I² = 0.0%). For reducing RSBP, regular RT with moderate or heavy loads may be more beneficial than regular RT with light loads. [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]

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]

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]

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]

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]

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]

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]

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]

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]

Aim: To evaluate the effectiveness of psychological interventions in reducing fear of cancer recurrence in breast cancer survivors. Design: A systematic review and meta‐analysis. Data Sources: PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL, Scopus, PsycINFO, Web of Science and ClinicalTrials.gov were searched for relevant studies published from 1 January 1976 to 28 November 2020. Methods: Eligible randomized controlled trials on psychological interventions for reducing fear of cancer recurrence in breast cancer survivors were included in meta‐analysis. Review Manager 5.4 was used to conduct the meta‐analysis, and the fear of cancer recurrence score was calculated by using standardized mean differences and 95% confidence intervals. Risk of bias was assessed with the Cochrane risk‐of‐bias tool. Quality of evidence, sensitivity analyses, and subgroup analyses were also conducted. Results: This systematic review included 16 randomized controlled trials. We found psychological interventions significantly reduced fear of cancer recurrence. Subgroup analyses indicated that mindfulness and acceptance therapy‐based interventions reduced fear of cancer recurrence, whereas cognitive‐behavioural therapy combined with psychoeducation did not. Interventions with three to eight sessions were effective, while interventions with nine or more sessions were not. Face‐to‐face interventions were effective, whereas online interventions were not. The quality of evidence for fear of cancer recurrence was evaluated as moderate due to moderate heterogeneity in the included studies. Conclusions: Psychological interventions were effective in reducing fear of cancer recurrence in breast cancer survivors. Mindfulness and acceptance therapy‐based interventions and short‐term interventions are recommended. Future well‐designed randomized controlled trials aiming to examine the effectiveness of psychological interventions in reducing fear of cancer recurrence are needed. Impact The findings of this systematic review may guide the development of psychological interventions and encourage the use of psychological interventions for reducing fear of cancer recurrence in breast cancer survivors. [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]

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: 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]

Aim: Hiesho is a condition characterized by having a cold sensation in the hands or feet (i.e., sensitivity of the hands or feet to cold). This condition is common among Japanese women and is an important health problem. In this study, we aimed to evaluate a hiesho intervention program for nurses called "Preventing Hiesho: Intervention Program for Educating Nurses" in terms of its effectiveness in improving the knowledge and perceptions of nurses about the importance of hiesho care. Methods: A total of 130 nurses from Japanese hospitals and clinics providing prenatal care participated in our randomized controlled trial. Sixty‐eight nurses participated in the "Preventing Hiesho: Intervention Program for Educating Nurses" for 2 weeks (intervention group). Sixty‐two nurses received a pamphlet on hiesho care (control group). The responses of the participants to the questionnaire survey were collected by postal mail. An intention‐to‐treat analysis of the results was conducted. Results: One week after the implementation of the web‐based learning program, the scores of knowledge and perceptions of the importance of administering hiesho care were significantly higher in the intervention group than in the control group. Conclusions: A 2‐week web‐based learning program for educating nurses on preventing hiesho significantly improved their knowledge and perceptions of the importance of hiesho care. [ABSTRACT FROM AUTHOR]

As one of the most widely used mindfulness‐based psychotherapeutic intervention techniques, mindfulness‐based stress reduction (MBSR) has emerged as an auxiliary or alternative technique for the treatment of post‐traumatic stress disorder (PTSD). This study conducted a meta‐analysis of the effect of MBSR on the changes in symptoms in PTSD patients. The final search was conducted on 10 December 2021, and 10 eligible randomized controlled trials were identified, including 768 participants. A quality assessment was conducted. Proportional sensitivity analysis and random effects meta‐analysis were performed, and the 95% confidence interval was calculated. Subgroup analyses were also conducted to identify moderators (e.g., features of population and intervention). Compared with the control condition, MBSR significantly reduced the symptoms of PTSD patients and had a moderately positive effect (g = 0.46, 95% CI: 0.31–0.62, p < 0.001). This was the case in people who suffer from PTSD for different reasons, indicating that MBSR is an effective treatment for PTSD symptoms in PTSD patients. It was feasible to implement MBSR interventions for PTSD patients caused by different reasons. [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]

Background: Total knee arthroplasty (TKA) is a standard treatment for end-stage degenerative knee disease. Most patients will experience moderate-to-severe postoperative knee pain, significantly affecting rehabilitation. However, controversy remains regarding the efficacy of adding the interspace between the popliteal artery and capsule of the knee (IPACK) into multimodal analgesia protocol. Methods: PubMed, Medline, Embase, Cochrane Library, and other databases were searched from inception to February 1, 2021. Studies comparing patients receiving IPACK to patients not receiving IPACK were included. The primary outcome was the ambulation pain score on a visual analogue scale (VAS) of 0–10. Secondary outcomes included pain score at rest, morphine usage, functional recovery, clinical outcomes, and complications. Results: Thirteen RCTs involving 1347 knees were included. IPACK was associated with lower ambulation pain scores (weight mean difference [WMD] − 0.49, 95% confidence interval [CI] − 0.72 to − 0.26). The benefits were observed from 2 to 4 h, 6 to 12 h, and beyond one week. IPACK also significantly reduced rest pain scores (WMD − 0.49, 95% CI − 0.74 to − 0.24), and the benefits were observed from 6 to 12 h and beyond one week. IPACK reduced the overall morphine consumption (WMD − 2.56, 95% CI − 4.63 to − 0.49). Subgroup analysis found reduced oral morphine consumption from 24 to 48 h (WMD − 2.98, 95% CI − 5.71 to − 0.24) and reduced rate of morphine requirement from 12 to 24 h (relative risk [RR] = 0.51, 95% CI 0.31 to 0.83). Functional recovery outcomes regarding ambulation distances (on the second postoperative day [POD2]) (WMD = 1.74, 95% CI 0.34 to 3.15) and quadriceps muscle strength (at 0 degree) (WMD = 0.41, 95% CI 0.04 to 0.77) favored IPACK. And IPACK reduced the rate of sleep disturbance (on POD 1) (RR = 0.39, 95% CI 0.19 to 0.81). There was no significant difference in the other outcomes. Conclusions: Moderate-level evidence confirmed that IPACK was related to better results in pain scores, morphine usage, and functional recovery without increasing the risk of complications. Registration: CRD42021252156. Key points: Question Can IPACK as an additional analgesic method provide better results on postoperative knee pain and function recovery for patients after TKA? Findings Moderate evidence suggested that the addition of IPACK to themultimodal analgesia programs had better results on postoperative knee pain VAS scores, morphine usage, ambulation distances, muscle strength, and sleep disturbance without increasing the risk of complications, compared to those without IPACK. However, these differences in pain VAS scores, ambulation distances, and muscle strength were minor and had relative clinical significance. The reduced morphine consumption significantly confirmed the benefits of IPACK. Meaning The combinations of IPACK with other regional analgesia techniques (e.i. PAI, ACB) are recommended as an integral part of multimodal analgesia programs. More trials were needed to confirm the benefits of IPACK in different combinations. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to examine the effectiveness of an augmented home visiting programme in preventing intimate partner violence among Latinx mothers by nativity. Background: Intimate partner violence diminishes home visit programmes' effectiveness. Immigrant Latinx mothers are especially vulnerable and need culturally tailored prevention. Methods: We performed secondary analyses of 33 US‐born and 86 foreign‐born Latinx mothers at baseline and 1‐ and 2‐year follow‐up in a longitudinal randomized controlled trial of the Nurse‐Family Partnership programme augmented with nurse‐delivered Within My Reach relationship education curriculum and violence screening and referrals in Oregon. We estimated proportional odds models via generalized estimating equations on total physical and sexual victimization and/or perpetration forms (an ordinal variable), adjusting for intervention, wave, age and education. Results: The intervention–nativity interaction was not significant (p =.953). Foreign‐born status was associated with lower reported violence at baseline (adjusted odds ratio: 0.29, 95% confidence interval: 0.13–0.67, p =.004). This association was marginally significant at 1‐year follow‐up (0.43, 0.17–1.08, p =.072) and not significant at 2‐year follow‐up (0.75, 0.33–1.67, p =.475). Conclusions: This augmented programme was not effective for Latinx mothers by nativity. Their nativity gap diminished over time. Implications for Nursing Management: Nursing leaders should support culturally tailored home visiting programmes to detect and prevent intimate partner violence affecting Latinx immigrants. Clinical Trial Registration: This study is registered at www.clinicaltrials.gov NCT01811719. The full trial protocol can be accessed at https://clinicaltrials.gov/ct2/show/NCT01811719. [ABSTRACT FROM AUTHOR]

Purpose This study was conducted to systematically examine the effect of decision support systems (DSSs) applied to patients with cancer on pain severity. Review methods: Systematic review and meta‐analysis. A search was done on Web of Science, Science Direct, PubMed, ProQuest, EBSCOhost/CINAHL Complete, Scopus, Springer Link, Cochrane Library, and Ovid databases, which covered a period until September 2021. Meta‐analysis of the data was conducted on the CMA 3 software package. Comprehensive reviews were conducted by two independent researchers in line with the PICOS criteria. The study was conducted according to the PRISMA checklist. Findings Five randomized controlled trials with 1.880 participants were included in this systematic review and meta‐analysis. In the study, visits, consultations, simulation of patient outcomes, telephone support, and email applications were employed for periods ranging from 6 weeks to 6 months. The evaluation of the meta‐analysis results indicated that DSSs had positive effects on pain severity in patients with cancer (Hedge's g = 0.22; p < 0.001). Conclusion: The findings of this systematic review and meta‐analysis show that DSSs can be used as an effective and comfortable technological application in reducing the severity of pain in patients with cancer. Clinical relevance: The use of DSSs for pain severity in patients with cancer is an effective method. In line with the findings of this systematic review and meta‐analysis, awareness and knowledge levels of all health disciplines about DSSs will increase. It is believed that the use of DSSs to improve patient‐centered care will be guiding. [ABSTRACT FROM AUTHOR]