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Context: The long duration and high cost of anterior cruciate ligament reconstruction (ACLR) rehabilitation can pose barriers to completing rehabilitation, the latter stages of which progress to demanding sport-specific exercises critical for a safe return to sport. A staged approach shifting in-person physiotherapy sessions to later months of recovery may ensure patients undergo the sport-specific portion of ACLR rehabilitation. Design/Objective: To compare postoperative outcomes of knee function in patients participating in a staged ACLR physiotherapy program to patients participating in usual care physiotherapy through a randomized controlled trial. Methods: One hundred sixty-two patients were randomized to participate in staged (n = 80) or usual care physiotherapy (n = 82) following ACLR and assessed preoperatively and postoperatively at 2 weeks, 6 weeks, 3 months, and 6 months. The staged group completed the ACLR rehabilitation protocol at home for the first 3 months, followed by usual care in- person sessions. The usual care group completed in-person sessions for their entire rehabilitation. Outcome measures included the Lower Extremity Functional Scale, International Knee Documentation Committee Questionnaire, pain, range of motion, strength, and hop testing. Results: There were no statistically significant between-group differences in measures of knee function at 6 months postoperative. Patients in the usual care group reported significantly higher International Knee Documentation Committee scores at 3 months postoperative (mean difference = 5.8; 95% confidence interval, 1.3 to 10.4; P = .01). Conclusion: A staged approach to ACLR rehabilitation does not appear to impede knee function at 6 months postoperative but may result in worse patient reported outcomes at early follow-ups. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to examine the acute and chronic effects of wild blueberry supplementation on mood, executive function, and serum biomarkers of neuroplasticity, inflammation, and oxidative stress in emerging adults with moderate-to-severe depressive symptoms. Methods: In this double-blind trial, 60 emerging adults (Mage = 20.0 years, 32% male) with self-reported depressive symptoms were randomly assigned to receive a single blueberry drink (acute phase), followed by 6 weeks of daily blueberry supplementation (chronic phase), or a matched placebo drink. The primary outcome was Beck Depression Inventory-II (BDI-II) scores at 6-week follow-up. Further measures included momentary affect (PANAS-X) and accuracy on an executive function task. The data were analyzed using ANCOVAs adjusted for baseline values, sex, and habitual fruit and vegetable intake. Estimated marginal means were calculated to compare the treatment arms. Results: The blueberry drink significantly improved positive affect (p = 0.026) and executive function (p = 0.025) at 2 h post-ingestion, with change scores being positively correlated in the blueberry group (r = 0.424, p = 0.017). However, after six weeks of supplementation the reduction in BDI-II scores was greater in the placebo group by 5.8 points (95% CI: 0.8–10.7, p = 0.023). Generalized anxiety and anhedonia also decreased significantly more in the placebo group. No significant differences were found for any of the biomarkers. Conclusions: Six weeks of wild blueberry supplementation were inferior to placebo in reducing depressive symptoms. Nevertheless, the correlated improvements in positive affect and executive function after a single dose of blueberries point to a beneficial, albeit transient, psychological effect. These contrasting results suggest a biphasic, hormetic-like response that warrants further investigation. Trial registration: NCT04647019, dated 30 November, 2020. [ABSTRACT FROM AUTHOR]

To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge. Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL). The experimental group also received experimental occupational therapy services to address goals identified through the administration of the Canadian Occupational Performance Measure (COPM). Experimental occupational therapy began during the in-hospital phase and continued in the home-based setting. It consisted of teaching strategies, recommending aids, and providing personalized information regarding available community support. Ninety-two individuals with a mean age of 65 years (female 44.6%) were enrolled. The experimental group significantly improved participation measured by the Reintegration to Normal Living Index (mean changes 8.61, 95% CI: 1–16.23, p = 0.027). The performance and satisfaction scores of the COPM, both during hospitalization and after discharge, and independence in ADL also improved. No differences in mood disturbances were found. Early post-discharge occupational therapy integrated with multidisciplinary rehabilitation improves the social participation of complex patients. Future research should investigate the concrete feasibility of implementing this complex intervention cost-effectively and in different contexts. ClinicalTrials.gov Identifier NCT03668938 (first posted date 13/09/2018) Early post-discharge rehabilitation assists patients' transition from hospital to home by improving the management of problems they encounter. In complex patients, occupational therapy initiated during hospitalization and extended to the early post-discharge phase improves social participation, independence in basic and instrumental daily activities, and performance and satisfaction when carrying out relevant occupational activities. The strong partnership between the Occupational Therapist and the patient improves compliance to treatment, enhancing the chances of success of rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Background: Despite the implementation of various postoperative management strategies, the prevalence of postoperative fatigue syndrome (POFS) remains considerable among individuals undergoing laparoscopic radical gastrectomy. While the N-methyl-D-aspartic acid receptor antagonist esketamine has demonstrated efficacy in enhancing sleep quality and alleviating postoperative pain, its impact on POFS remains uncertain. Consequently, the objective of this study is to ascertain whether perioperative administration of esketamine can effectively mitigate the occurrence of POFS in patients undergoing laparoscopic radical gastrectomy. Methods: A total of 133 patients diagnosed with gastric cancer were randomly assigned to two groups, namely the control group (Group C) (n = 66) and the esketamine group (Group E) (n = 67), using a double-blind method. The Group C received standardized anesthesia, while the Group E received esketamine in addition to the standardized anesthesia. The primary outcome measure assessed was the Christensen fatigue score at 3 days after the surgical procedure, while the secondary outcomes included the disparities in postoperative fatigue, postoperative pain, sleep quality, and adverse reactions between the two groups. Results: In the group receiving esketamine, the fatigue scores of Christensen on the third day after surgery were significantly lower compared to the Group C (estimated difference, -0.70; 95% CI, -1.37 to -0.03; P = 0.040). Additionally, there was a significant decrease in the occurrence of fatigue in the Group E compared to the Group C on the first and third days following surgery (P < 0.05). Also, compared to individuals who had distal gastrectomy, those who had entire gastrectomy demonstrated a higher degree of postoperative tiredness reduction with esketamine. Furthermore, the Group E exhibited reduced postoperative pain and improved sleep in comparison to the Group C. Both groups experienced similar rates of adverse events. Conclusions: The use of esketamine during the perioperative period can improve POFS after laparoscopic radical gastrectomy, without adverse reactions. Trial registration: Registered in the Chinese Clinical Trial Registry (ChiCTR2300072167) on 05/06 /2023. [ABSTRACT FROM AUTHOR]

Background: There is inconsistent utilisation of clinical practice guidelines (CPGs) for cardiovascular disease (CVD) screening and management by healthcare professionals to identify CVD risk factors early and to intervene using current recommendations. To address this issue, the Cardiovascular Assessment Screening Program (CASP) was developed, implemented, and evaluated. This manuscript reports on the second phase of an exploratory sequential mixed methods study that tested the effectiveness of the CASP with nurse practitioners (NPs) and patients in Canada. Methods: A two-armed, non-blinded, cluster randomised controlled trial (cRCT) compared the NP-led implementation of CASP with usual care by NPs in community practice clinics across one Canadian province. The NPs were the cluster variable as their screening practices could be affected by their educational training, resources, or other factors. NPs were eligible for inclusion in the study if they were located in different urban and rural community settings and could conduct follow-up visits with patients. NPs recruited and enrolled the patients from their own practices as participants if they were healthy individuals, aged 40–74 years, with no established CVD or vascular disease. Researchers randomly allocated the NPs (n = 10) to the intervention group (IG) or the control group (CG). Results: Eight (8) NPs and 167 patients participated in the cRCT study. Patient participant-level data were analysed by the originally assigned groups IG (n = 68) and CG (n = 99). Utilising GLM (generalized linear modeling) more IG patients (90%; n = 61) received comprehensive CVD screening compared to the CG patients (2%; n = 2), RR = 30.2, 95% CI [8.76, 103.9], p <.0001, controlling for the effect of NP and BP category. Conclusion: NP implementation of CASP was effective for comprehensive screening compared to usual care and led to identifying previously unknown CVD risk factors, calculated FRS, heart health priorities and personalised goal-setting. Trial registration: ClinicalTrial.gov ID#: NCT03170752, date of registration 2017/05/31. [ABSTRACT FROM AUTHOR]

Background Among individuals with vitamin D deficiency, daily vitamin D supplementation appears to lower risk of acute respiratory infection. However, recent trials, in different populations and using different regimens, have yielded null results. We investigated the effect of daily vitamin D supplementation (vs placebo) on risk of upper respiratory infection (URI) in older adults. Methods The VITamin D and OmegA-3 TriaL (VITAL) is a randomized, double-blind, placebo-controlled trial of supplemental vitamin D and/or omega-3 fatty acids in generally healthy men (age ≥50 years) and women (age ≥55 years). This prespecified analysis focuses on vitamin D3 (2000 IU/day) versus placebo in the 15 804 (61%) participants with baseline serum total 25-hydroxyvitamin D level. The primary outcome was self-report of a recent URI at 1-year follow-up. Results Participants had a mean age of 68 years and 51% were women; 76% were non-Hispanic White, 16% Black, and 8% other race/ethnicity. The mean 25-hydroxyvitamin D level at baseline was 31 (standard deviation, 10) ng/mL, with <12 ng/mL in 2.4%. The overall effect of vitamin D supplementation on recent URI was nonsignificant (odds ratio [OR], 0.96 [95% confidence interval {CI},.86–1.06]). In the prespecified subgroup of primary interest (<12 ng/mL and denied taking concurrent vitamin D), which had only 255 participants, vitamin D supplementation was nonsignificant (OR, 0.60 [95% CI,.28–1.30]). Statistical power to assess effect modification in other subgroups was limited. Conclusions In older adults not selected for vitamin D deficiency, supplemental vitamin D did not lower URI risk overall. Whether effects differ in subgroups requires further study. Clinical Trials Registration. NCT01169259. [ABSTRACT FROM AUTHOR]

Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [ABSTRACT FROM AUTHOR]

Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [ABSTRACT FROM AUTHOR]

Objective: Our ability to predict responsiveness to digital interventions for eating disorders has thus far been poor, potentially for three reasons: (1) there has been a narrow set of predictors explored; (2) prediction has mostly focused on symptom change, ignoring other aspects of the user journey (uptake, early engagement); and (3) there is an excessive focus on the unique effects of predictors rather than the combined contributions of a predictor set. We evaluated the univariate and multivariate effects of outcome predictors in the context of a randomized trial (n = 398) of digitally delivered interventions for recurrent binge eating. Method: Thirty baseline variables were selected as predictors, ranging from specific symptoms, to key protective factors, to technological acceptance, and to online treatment attitudes. Outcomes included uptake, early engagement, and remission. Univariate (d) and multivariate (D) standardized mean differences were calculated to estimate the individual and combined effects of predictors, respectively. Results: At the univariate level, few predictors produced an effect size larger than what is considered small (d >.20) across outcomes. However, our multivariate approach enhanced prediction (Ds =.65 to 1.12), producing accuracy rates greater than chance (63%–71% accuracy). Less than half of the chosen variables proved to be useful in contributing to predictions in multivariate models. Conclusion: Findings suggest that accuracy in outcome prediction from digitally delivered interventions may be better driven by the aggregation of many small effects rather than one or several largely influential predictors. Replication with different data streams (sensor, neuroimaging) would be useful. Public Significance: Our ability to predict who will and will not benefit from digital interventions for eating disorders has been poor. We highlight the viability of a multivariate approach to outcome prediction, whereby prediction may be better driven by the aggregation of many small effects rather than one or a few influential predictors. [ABSTRACT FROM AUTHOR]

Background: High consumption of sugar-sweetened beverages (SSB) is a global health concern. Additionally, sugar-sweetened beverage (SSB) consumption is disproportionately high among adolescents and adults in rural Appalachia. The primary study objective is to determine the intervention effects of Kids SIPsmartER on students' SSB consumption. Secondary objectives focus on caregivers' SSB consumption and secondary student and caregiver outcomes [e.g, body mass index (BMI), quality of life (QOL)]. Methods: This Type 1 hybrid, cluster randomized controlled trial includes 12 Appalachian middle schools (6 randomized to Kids SIPsmartER and 6 to control). Kids SIPsmartER is a 6-month, 12 lesson, multi-level, school-based, behavior and health literacy program aimed at reducing SSB among 7th grade middle school students. The program also incorporates a two-way text message strategy for caregivers. In this primary prevention intervention, all 7th grade students and their caregivers from participating schools were eligible to participate, regardless of baseline SSB consumption. Validated instruments were used to assess SSB behaviors and QOL. Height and weight were objectively measured in students and self-reported by caregivers. Analyses included modified two-part models with time fixed effects that controlled for relevant demographics and included school cluster robust standard errors. Results: Of the 526 students and 220 caregivers, mean (SD) ages were 12.7 (0.5) and 40.6 (6.7) years, respectively. Students were 55% female. Caregivers were mostly female (95%) and White (93%); 25% had a high school education or less and 33% had an annual household income less than $50,000. Regardless of SSB intake at baseline and relative to control participants, SSB significantly decreased among students [-7.2 ounces/day (95% CI = -10.7, -3.7); p < 0.001, effect size (ES) = 0.35] and caregivers [-6.3 ounces/day (95% CI = -11.3, -1.3); p = 0.014, ES = 0.33]. Among students (42%) and caregivers (28%) who consumed > 24 SSB ounces/day at baseline (i.e., high consumers), the ES increased to 0.45 and 0.95, respectively. There were no significant effects for student or caregiver QOL indicators or objectively measured student BMI; however, caregiver self-reported BMI significantly decreased in the intervention versus control schools (p = 0.001). Conclusions: Kids SIPsmartER was effective at reducing SSB consumption among students and their caregivers in the rural, medically underserved Appalachian region. Importantly, SSB effects were even stronger among students and caregivers who were high consumers at baseline. Trial registration: Clincialtrials.gov: NCT03740113. Registered 14 November 2018– Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03740113. [ABSTRACT FROM AUTHOR]

Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]

Mobile health applications (mHealth apps) may lead to health benefits. In recent years, the use of apps in multiple sclerosis (MS) has increased. Apps to train and improve dexterity in MS are scarce. This study investigated the effectiveness of a tablet app-based home-based training to improve dexterity in individuals with MS. In a randomized controlled trial, two standardized 4-week home-based interventions focussing on different aspects of dexterity and upper limb function were compared. Assessments were done at baseline, post-intervention and 12-week follow-up. The primary endpoint was the Arm Function in Multiple Sclerosis Questionnaire, a dexterity-related measure of patient-reported activities of daily living. Secondary endpoints were dexterous function, grip strength and health-related quality of life. Forty-eight individuals were randomly assigned to a tablet app-based program (n = 26) or a control strengthening exercise program (n = 22). No significant differences were found for the primary endpoint (p = 0.35). Some significant differences in favour of the app-group were found in fine coordinated finger movements and strength. No significant differences were found at the 12-week follow-up for all endpoints. Adherence in both groups was above 90%. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. However, app-based training was found to be effective in improving specific dimensions (finger movements and strength), and can easily be applied at home. Therefore, individuals living with MS with impaired dexterity should consider app-based training. Clinicaltrials.gov NCT03369470. This study provides initial evidence for the effectiveness of a home-based app-based program for improving dexterous function in individuals living with multiple sclerosis through the implementation of a tablet app-based dexterity training. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. Patients attending the app-based dexterity program showed some statistically significant improvements in fine coordinated finger movements and strength. [ABSTRACT FROM AUTHOR]

We report midline impacts of a community-randomized cash transfer intervention to 1857 vulnerable mothers in 140 rural cocoa-farming communities of Côte d'Ivoire. Compared to mothers in the comparison group who participated in village savings and loan associations (VSLAs), treatment mothers participated in VSLAs and received 8 € each week for up to one year with no conditions attached (the midway point of a two-year program). We find small- to moderate-sized treatment effects on four of six indicators of economic well-being (d = 0.23–0.75), as well as small reductions in maternal stress (d = −0.27). We find no statistically detectable impacts on educational engagement, educational aspirations, or educational expectations for children. Results suggest that cash transfer programs in rural West African communities can improve economic well-being and reduce maternal stress. Implications for children and families and for future cash transfer evaluations are discussed. [ABSTRACT FROM AUTHOR]

Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

Background: There are many barriers to engaging in current psychological treatments, including time, cost, and availability. Ultra-brief treatments overcome some of these barriers by delivering therapeutic information and skills using significantly less time than standard-length treatments. We developed a therapist-guided online ultra-brief treatment for depression and anxiety and compared it to an existing 8-week, 5-lesson therapist-guided standard-length treatment and a waitlist control. Methods: In a randomized controlled trial, adults with self-reported depression or anxiety were randomized (1:1:1) to the ultra-brief treatment, standard-length treatment, or waitlist control. The primary outcomes were depression symptoms and anxiety symptoms assessed at baseline, 5-weeks later, 9-weeks later (primary timepoint), and 3-months later. The trial was prospectively registered. Results: Between 7 February 2022, and 16 August 2022, 242 participants were enrolled in the ultra-brief treatment (n = 85), standard-length treatment (n = 80), and waitlist control (n = 77). Participants were mostly women with an average age of 48.56 years. At 9-weeks post-baseline, participants in the ultra-brief treatment group reported significantly lower depression (between groups d = 0.41) and anxiety (d = 0.53) than the waitlist control. The ultra-brief treatment was non-inferior for anxiety at both 9-weeks and 3-months follow-up. Non-inferiority for depression was observed at 9-weeks. Conclusions: The online ultra-brief treatment resulted in significant reductions in depression and anxiety that were non-inferior to a longer treatment course after 9-weeks. Remotely delivered ultra-brief treatments have the potential to provide accessible and effective care for those who cannot, or would prefer not to, access longer psychological interventions. [ABSTRACT FROM AUTHOR]

Acute exercise induces changes within the T-cell compartment, especially in cytotoxic CD8+ memory subsets, depending on exercise intensity and duration. It is unclear whether exercise-induced changes in major T-cell subsets differ in response to acute high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT) and whether sex-specific effects exist. Twenty-four recreationally active runners (females: n=12, 27.8±4.1years, 54.4±4.6 ml*kg-1 *min-1 ; males: n=12, 31.6±3.8years, 58.9±7.7 ml*kg-1 *min-1) participated in this randomized controlled crossover study, and conducted an energy- and duration-matched HIIT and MICT session. Blood was sampled before (T1), immediately (T2) and 1 h after exercise (T3). Flow cytometry was used to identify T-cell populations. HIIT decreased the proportion of CD8+ T-cells more pronounced at T3 compared to MICT (p=0.007), induced a significantly stronger increase in the CD8+ effector memory (TEM) cell proportion at T2 (p=0.032), and decreased CD4+ central memory proportion more pronounced at T2 (p=0.029). A decrease below baseline CD8+ TEM proportion at T3 was observed only after HIIT (p<0.001). No interaction effects between sexes were revealed. Taken together, HIIT represents a more potent stimulus to induce shifts mainly within the cytotoxic CD8+ T-cell compartment, thereby giving implications to investigate the role of HIIT on the cell´s effector phenotype and function in more detail. [ABSTRACT FROM AUTHOR]

This randomized controlled trial aimed to assess the efficacy of the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered cognitive-emotional intervention, among the homebound older population presenting with mild cognitive impairment and depressive or anxiety symptoms. Participants were randomly assigned either to the intervention group or the treatment-as-usual group and completed baseline, post-intervention, and three-month follow-up assessments. Changes in episodic memory and symptoms of depression and anxiety were the primary outcomes. Secondary outcomes included changes in global cognition, attentional control, subjective memory complaints, functional status, and quality of life. Data were analyzed on an intention-to-treat basis employing a linear mixed models approach. ClinicalTrials.gov identifier: NCT05499767. Compared with the treatment-as-usual group, the HEPPI group reported significant immediate improvement in cognition, mood, and daily functional performance. Positive effects of HEPPI were maintained over the follow-up phase only in depressive symptomatology, perceived incapacity to perform advanced instrumental activities of daily living, and self-reported emotional ability. A significant impact of the intervention on the subjective memory complaints level was observed only three months after the intervention. This study suggests that HEPPI may be a promising home-delivered cognitive-emotional intervention to help homebound older adults improve their mental health. [ABSTRACT FROM AUTHOR]

Background: In Traditional Chinese Medicine (TCM) theory, cold dampness obstruction is one of the common syndromes of osteoarthritis. Therefore, in clinical practice, the main treatment methods are to dispel wind, remove dampness, and dissipate cold, used to treat knee osteoarthritis (KOA). This report describes a mulitercenter clinical study to assess Zhuifeng Tougu Capsule's efficacy and safety in the treatment of patients who are cold dampness obstruction syndrome in KOA, and to provide evidence-based medical for the rational use of Zhuifeng Tougu Capsules in clinical practice. Methods: This randomized, parallel group controlled, double-blind, double dummy trial will include a total of 215 KOA patients who meet the study criteria. 215 patients underwent 1:1 randomisation, with 107 cases assigned the experimental group (Zhuifeng Tougu Capsules + Glucosamine Sulfate Capsules Simulator) and 108 assigned the control group (Glucosamine Sulfate Capsules + Zhuifeng Tougu Capsules Simulator). After enrolment, patients received 12 weeks of treatment. The main efficacy measure is the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score. Visual analogue scale (VAS) pain score, Self-condition assessment VAS score, WOMAC KOA score, TCM syndrome score and TCM syndrome efficacy, ESR level, CRP level, suprapatellar bursa effusion depth, use of rescue drugs, and safety indicators are secondary efficacy indicators. Results: Compared with before treatment, WOMAC pain score, VAS pain score, Self-condition assessment VAS score, WOMAC KOA score, and TCM syndrome score decreased significantly in both groups (P < 0.01). Also, the experimental group showed significant differences in the above indicators compared to control (P < 0.01). However, after treatment, no significant differences were showed in the ESR level, CRP level, and suprapatellar bursa effusion depth between the two groups (P > 0.05). No any serious adverse effects showed in the experimental group and control group. Conclusions: Zhuifeng Tougu Capsules can effectively improve knee joint function and significantly alleviate the pain of KOA. Trial registration: Clinical trial registration was completed with the China Clinical Trial Registration Center for this research protocol (No. ChiCTR2000028750) on January 2, 2020. [ABSTRACT FROM AUTHOR]

Background: Intensive care unit (ICU) patients often experience significant physiological stress. This study evaluated the effect of a defined family visitation protocol on physiological responses in the ICU. Methods: A randomized, block-randomized clinical trial was conducted on 78 ICU patients at Imam Reza Hospital between February 8, 2017, and August 8, 2017. The intervention group received protocol-based visits, and the control group continued with standard visitation. Block randomization was utilized for group assignments. The primary outcome was the measurement of physiological signs using designated monitoring devices. Data were analyzed using SPSS version 22, employing independent t-tests, Mann-Whitney U test, repeated measures analysis, and Friedman's test. Results: The results showed no significant differences in systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, and arterial blood oxygen levels between the two groups. However, heart rate in the intervention group was significantly lower in three stages before, during, and after the meaningful visiting (P = 0.008). Conclusion: Protocol-based scheduled family visits in the ICU may reduce physiological stress, as evidenced by a decrease in patients' heart rate. Implementing tailored visitation protocols sensitive to patient preferences and clinical contexts is advisable, suggesting the integration of family visits into standard care practices for enhanced patient outcomes. Trial Registration: IRCT20161229031654N2; 25/01/2018; Iranian Registry of Clinical Trials (https://en.irct.ir). [ABSTRACT FROM AUTHOR]

Purpose: This study compared the effectiveness of age‐appropriate, high technology, interactive virtual reality (VR) distraction with standard care (SC) provided by the nurse on adolescents' acute procedural pain intensity perception during burn wound care treatment in the ambulatory clinic setting. Design: This randomized controlled trial included 43 adolescents ages 10–21 from the ambulatory burn clinic of a large children's hospital. Methods: Blinded study participants were randomly assigned to either VR or SC (non‐significantly different, current mean burn surface area, 1.3 and 1.7, respectively) during the first burn wound care procedure in the burn clinic. Blinded research staff collected pre‐procedure data including Spielberger's State‐Trait Anxiety Inventory and postprocedure wound care pain intensity using the Adolescent Pediatric Pain Tool. A total of 41 participants completed all study procedures. Results: No statistically significant difference in burn wound care procedural pain was noted between the VR and SC groups after adjusting for several factors. Pre‐procedure state and trait anxiety correlated with reported pre‐procedure pain. Wound care pain was found to be significantly associated with pre‐wound care pain score, time from original burn to clinic burn care treatment, and length of wound care treatment. These factors accounted for approximately 45% of the variation in pain scores during wound care treatment. Practice Implications: VR distraction can be a useful pain management strategy but may not take the place of the unique nurse‐patient relationship that occurs during clinical encounters. Tailoring pain management during burn wound care requires consideration of anxiety, time from the burn injury to the wound care procedure, length of time of the wound care procedure, and pretreatment pain level. Knowing patients' needs, desires, and temperaments along with the specifics about the healthcare procedures are critical to formulating individualized care plans that may or may not include VR. Newer technology, such as easier‐to‐use, less expensive VR, may assist with translation into practice making its clinical use more routine. [ABSTRACT FROM AUTHOR]

This study sought to evaluate the impact of the subcutaneous tunneling technique on peripherally inserted central catheter (PICC) placement. We randomized 694 patients who needed PICC placement to either the tunneled PICCs (experimental group) or the non-tunneled PICCs (control group) from August to December 2021. The cumulative frequency of complications was assessed as the primary outcome. Secondary outcomes comprised of the amount of bleeding, catheter insertion time, self-reported pain score, and one-puncture success rate. After 6 months of follow-up, the tunneled PICCs group showed a significant decrease in the frequency of total complications, especially in infection (3.0% vs. 7.1%, p =.021) and catheter-related thrombosis (3.3% vs. 8.3%, p =.008), although approximately 0.5 ml bleeding and 3.5 min time were increased. This randomized multicenter study supports the efficacy of subcutaneous tunneling technology in reducing PICC-related complications, enhancing patient comfort, and encouraging using subcutaneous tunneling technology for PICC placement. [ABSTRACT FROM AUTHOR]

Background and aims: Controlled drinking (CD) is an attractive treatment goal for a large proportion of individuals with alcohol use disorder (AUD), but the availability of treatment methods supporting a goal of CD is scarce. We tested if behavioural self‐control training (BSCT) was superior to motivational enhancement therapy (MET) for individuals with AUD with a treatment goal of CD. Design: Randomized controlled two‐group trial. Follow‐ups were conducted at 12 and 26 weeks (primary end‐point) after inclusion. Setting: Three specialized dependency care clinics in Stockholm, Sweden. Participants: Two hundred and fifty self‐referred adults (52% men) fulfilling criteria of AUD (DSM‐5) and a stated treatment goal of CD. Intervention and comparator: BSCT (n = 125), a five‐session treatment based on cognitive behavioural therapy versus the active comparator, MET (n = 125), containing four sessions based on Motivational Interviewing. Measurements Primary outcome measure was mean weekly alcohol consumption at the 26‐week follow‐up, adjusted for baseline consumption. Conclusions: A randomized controlled trial found no evidence of a difference between behavioural self‐control training and motivational enhancement therapy in reducing weekly alcohol consumption. Both groups substantially reduced consumption and behavioural self‐control training was superior in reducing hazardous drinking. [ABSTRACT FROM AUTHOR]

Background Amphotericin B is the gold standard treatment for severe mycoses. A new orally delivered, less-toxic formulation of amphotericin has been developed. Methods In our randomized clinical trial, we tested oral lipid nanocrystal (LNC) amphotericin B (MAT2203, Matinas Biopharma) vs intravenous (IV) amphotericin for human immunodeficiency virus–associated cryptococcal meningitis in 4 sequential cohorts. Two pilot cohorts assessed safety and tolerability (n = 10 each), and 2 cohorts assessed efficacy with/without 2 IV loading doses (n = 40 each). The experimental arm received 1.8 g/d oral LNC amphotericin through 2 weeks with 100 mg/kg/d flucytosine, then 1.2 g/d LNC amphotericin through 6 weeks. The randomized control arm (n = 41) received 7 days of IV amphotericin with flucytosine, then 7 days of fluconazole 1200 mg/d. The primary end point was cerebrospinal fluid (CSF) early fungicidal activity (EFA). Results We randomized 80 participants to oral LNC amphotericin + flucytosine with (n = 40) and without (n = 40) 2 IV loading doses and 41 control participants to IV amphotericin + flucytosine. Mean EFA was 0.40 log10 colony-forming units (CFU)/mL/d for all-oral LNC amphotericin, 0.42 log10   Cryptococcus CFU/mL/d for oral LNC amphotericin with IV loading doses, and 0.46 log10 CFU/mL/d for IV amphotericin controls. LNC amphotericin groups achieved 2-week CSF sterility in 63% (44 of 70) vs 68% (23 of 34) of controls. The 18-week survival was 85% (34 of 40) with all-oral LNC amphotericin, 90% (36 of 40) with oral LNC amphotericin given IV loading doses, and 85% (35 of 41) with IV amphotericin. Grade 3–4 laboratory adverse events occurred less frequently in LNC amphotericin groups (41%) than the IV amphotericin group (61%, P =.05), particularly for anemia (21% vs 44%; P =.01) and potassium (5% vs 17%; P =.04). Conclusions This new oral amphotericin B LNC formulation appears promising for cryptococcal meningitis with antifungal activity, similar survival, and less toxicity than IV amphotericin. Clinical Trials Registration NCT04031833. [ABSTRACT FROM AUTHOR]

Aims: The study aimed to develop and evaluate the effects of a self‐determination theory‐based, nurse‐led, physical activity programme for postmenopausal women with rheumatoid arthritis. Methods: Between December 2019 and April 2020, this randomized controlled trial recruited 62 postmenopausal women with rheumatoid arthritis from a university‐affiliated hospital in South Korea. The intervention group participated in a self‐determination theory‐based, nurse‐led, physical activity programme that consisted of Tai Chi‐based physical activity, a supportive psychosocial strategy, and interactive counselling for 16 weeks, and the control group continued to undergo their usual care. Results: There were statistically significant group‐by‐time interactions in physical activity and perceived sarcopenia, which favoured the intervention group. Additionally, the intervention group showed significant improvements in the perceived therapeutic efficacy of physical activity, grip strength, walking speed, disease activity score, and health‐related quality of life. Conclusions: The programme developed in this study can be an effective and feasible approach for postmenopausal women with rheumatoid arthritis in improving physical activity, selected osteosarcopenic outcomes, and health‐related quality of life. Further research is required to investigate the long‐term effects of this theory‐based programme for postmenopausal women in diverse settings. Summary statement: What is already known about this topic? Tai Chi‐based physical activity has been known to be a component of self‐management for rheumatoid arthritis. What this paper adds? It highlights the efficacy of a theory‐based, nurse‐led, physical activity programme to improve the quality of life of postmenopausal women with rheumatoid arthritis.The evidenced‐based programme could be transferred to postmenopausal women with rheumatoid arthritis in clinical settings. The implications of this paper: The self‐determination theory‐based, nurse‐led, physical activity programme can improve physical and psychosocial outcomes in postmenopausal women with rheumatoid arthritis.Importantly, this nurse‐led and theory‐based programme is expected to be applicable to postmenopausal women with rheumatoid arthritis in clinical settings, including both hospitals and communities. [ABSTRACT FROM AUTHOR]

Background: The burden of sepsis is high in India and is associated with substantial morbidity and mortality. Vitamin C, an endogenous antioxidant, may improve patient outcomes. Methods: This was a parallel-group pilot feasibility randomized controlled trial conducted at 2 intensive care units in India. Adult patients (≥18 years) with proven or suspected infection as the main diagnosis and needing a continuous intravenous vasopressor infusion were randomized to intravenous vitamin C (50 mg/kg every 6 hours for a maximum of 16 doses) or matching placebo. Primary outcomes were related to protocol adherence and feasibility (enrollment per month). The key secondary outcome was the composite of mortality or persistent organ dysfunction (POD) at day 28 after randomization. Results: 60 patients were screened, 51 were eligible, 32 were randomized, and 30 were included in the analysis (randomized/eligible ratio: 0.63). The overall rate of enrollment was 1.5 patients per month. The median (IQR) age was 63.5 (51.0, 70.0) and 70.0% of the patients were male. In both arms, all patients received ≥90% of scheduled doses of the study drug. No patient received open-label vitamin C and there were no deviations from the glucose monitoring protocol. The composite outcome of mortality or POD at day 28 occurred in 56.3% (9/16) in the vitamin C arm as compared to 42.9% (6/14) in the placebo arm [RR: 1.31 (95% CI: 0.62, 2.76), p = 0.47]. Conclusion: In this pilot feasibility randomized controlled trial of vitamin C for adult patients with sepsis, protocol adherence was excellent and feasibility endpoints were met. Trial registration: CTRI/2020/03/024371. [ABSTRACT FROM AUTHOR]

Background: Alcohol use and its related consequences are a public health problem among young adults. Building upon efficacious personalized normative feedback interventions, dynamic norms can be used to highlight the decreasing prevalence of alcohol use over time among young adults' peers, thereby increasing their motivation to change drinking consistent with the trend. Because limited research has examined dynamic norms feedback interventions for alcohol use, we examined the acceptability and initial efficacy of such an intervention, and potential iatrogenic effects of showing norms feedback about drinking to light drinkers and nondrinkers. Methods: Participants were 546 unvaccinated young adults ages 18–24 who completed a baseline survey, intervention, and 1‐month follow‐up assessment. Participants were block randomized to receive a brief web‐based dynamic norms intervention, with feedback content focused on either (a) alcohol‐related behaviors (intervention) or (b) COVID‐19 vaccine behaviors (the attention‐matched control for the present study). Results: On average, participants who received the alcohol intervention rated it as generally engaging, helpful, and acceptable, with the majority (90.8%) indicating that they would recommend it to a friend. Supporting initial efficacy, in generalized linear models controlling for demographics and baseline alcohol outcomes, at 1‐month follow‐up the alcohol intervention was associated with statistically and clinically significant reductions in all indices of perceived drinking norms, drinking quantity, drinking frequency, and driving after drinking occasions. Lighter drinkers showed no adverse iatrogenic effects. Conclusions: Presenting alcohol‐related personalized normative feedback using dynamic trends is a promising intervention for reducing alcohol use in a community sample of young adults. Further research clarifying the optimal presentation of dynamic norms is needed. [ABSTRACT FROM AUTHOR]

The current paper reports long-term impacts of the Chicago School Readiness Project (CSRP) on measures of achievement, cognitive functioning, and behavioral regulation taken toward the end of students' high school careers. The CSRP was a self-regulation-focused early childhood intervention implemented in Head Start centers serving high-poverty neighborhoods in Chicago. The intervention was evaluated through a cluster randomized control trial, providing us with rare longitudinal evidence from an experimental study. However, the study was limited by issues with low power and baseline differences between experimental groups. Here, we report on follow-up data taken approximately 11–14 years after program completion, including measures of participants' (N = 430) academic achievement, executive functioning, emotional regulation, and behavioral problems, and we provide a range of analytic estimates to address the study's methodological concerns. Across our estimates, we found little evidence that the program had lasting impacts on indicators of late-adolescent functioning. Main effects were estimated with some imprecision, but nearly all models produced null effects across the broad array of outcomes considered. We also observed few indications that effects were moderated by posttreatment high school quality or later assignment to a light-touch mindset intervention. Implications for developmental theory and early childhood policy are discussed. Public Significance Statement: This study evaluated the long-term effects of an early childhood intervention focused on self-regulation. Despite initial promise, the authors found virtually no evidence to suggest that the preschool intervention had long-lasting positive effects on key outcomes such as achievement, college enrollment, or behavioral dysregulation. This work carries important implications for our continued development of early childhood programs targeting children from low-income families. [ABSTRACT FROM AUTHOR]

Background and Aims: There is little RCT evidence that brief interventions improve treatment seeking in individuals with severe alcohol use disorder (AUD) or treatment seeking reduces alcohol use. The aim was to test the efficacy of a brief intervention to increase treatment seeking in treatment naïve adults with severe AUD and measure its effects on alcohol use. Design: Parallel group, non‐pharmacologic RCT with intervention (n = 197) and active control (n = 203) conditions, with blinded assessors conducting follow‐ups at 1, 3 and 6 months. Setting: Online recruitment in a 17‐county region of upstate New York, USA. Participants: Inclusion criteria consisted of ages ≥18 years, Alcohol Use Disorders Identification Test score ≥16, exceeds recommended limits for alcohol use and no history of AUD treatment. n = 400; 50% female; 79% white; mean age, 40.7; mean education, 14.6 years. Intervention and comparator: One‐session telephone‐delivered interventions: Cognitive‐Behavioral Therapy for Treatment Seeking (CBT‐TS; intervention), review of a National Institute on Alcohol Abuse and Alcoholism pamphlet on AUD treatment (control). Measurements Self‐report of any AUD treatment use over 3 months (primary outcome) and two standard measures of alcohol use over 6 months (secondary outcomes). Findings Intent‐to‐treat analyses were used. Assessment follow‐up rates were ≥93%. Any alcohol‐related treatment use over 3‐month follow‐up was obtained by 38 (19%) intervention participants and 36 (18%) control participants, a non‐significant difference, χ2 [1] = 0.16, P = 0.689. Secondary analysis showed a significant interaction term between sex and intervention assignment (β = −1.197, P = 0.027). The interaction suggested CBT‐TS was effective in men (22% vs 13%), although the evidence was somewhat weak (P = 0.071), and it was not effective in women (17% vs 24%). Conclusions: A one‐session cognitive‐behavioral therapy intervention to increase treatment seeking in treatment naïve adults with severe alcohol use disorder did not increase treatment seeking. [ABSTRACT FROM AUTHOR]

Background and Objectives Outdoor falls can negatively affect the independence and well-being of community-dwelling older adults. Although there is some overlap, there are also differences in risk factors for indoor and outdoor falls. There are no existing community-based fall prevention programs that specifically target outdoor fall prevention. To fill this gap, the Stroll Safe program was developed. Research Design and Methods A cluster-randomized controlled trial design was used with randomization at the site level. Participants (N = 86) were aged 60 and older, with a history of an outdoor fall or who had a fear of falling outdoors. Eight naturally occurring retirement community program sites were randomly assigned to the treatment or wait list control group. Outcome measures included the Outdoor Falls Questionnaire, the Falls Behavioral Scale for the Older Person, and the Falls Efficacy Scale-International to examine knowledge of risks, safe strategy use, protective behaviors, and fear of falling. An Analysis of Covariance (ANCOVA) was used to compare change scores between groups with covariates included for any initial differences between groups. A linear mixed model was also conducted to account for any clustering effects. Results Significant differences (p s <.05) were found between groups for knowledge of outdoor fall risks and safe strategy use. Effect sizes were large (Cohen's d = 1.2–1.9). Results were retained at 6-week follow-up. Discussion and Implications Stroll Safe is effective in improving knowledge of outdoor fall risks and increasing safe strategy use for community mobility. Stroll Safe fills a gap in outdoor fall prevention programs. Clinical Trials Registration Number: NCT03624777 [ABSTRACT FROM AUTHOR]

Background: Dynamic interpersonal therapy (DIT) is a brief, structured psychodynamic psychotherapy with demonstrated efficacy in treating major depressive disorder (MDD). The aim of the study was to determine whether DIT is an acceptable and efficacious treatment for MDD patients in China. Method: Patients were randomized to 16-week treatments with either DIT plus antidepressant medication (DIT + ADM; n = 66), general supportive therapy plus antidepressant medication (GST + ADM; n = 75) or antidepressant medication alone (ADM; n = 70). The Hamilton Depression Rating Scale (HAMD) administered by blind raters was the primary efficacy measure. Assessments were completed during the acute 16-week treatment and up to 12-month posttreatment. Results: The group × time interaction was significant for the primary outcome HAMD (F = 2.900, df1 = 10, df2 = 774.72, p = 0.001) in the acute treatment phase. Pairwise comparisons showed a benefit of DIT + ADM over ADM at weeks 12 [least-squares (LS) mean difference = −3.161, p = 0.007] and 16 (LS mean difference = −3.237, p = 0.004). Because of the unexpected high attrition during the posttreatment follow-up phase, analyses of follow-up data were considered exploratory. Differences between DIT + ADM and ADM remained significant at the 1-, 6-, and 12-month follow-up (p s range from 0.001 to 0.027). DIT + ADM had no advantage over GST + ADM during the acute treatment phase. However, at the 12-month follow-up, patients who received DIT remained less depressed. Conclusions: Acute treatment with DIT or GST in combination with ADM was similarly efficacious in reducing depressive symptoms and yielded a better outcome than ADM alone. DIT may provide MDD patients with long-term benefits in symptom improvement but results must be viewed with caution. [ABSTRACT FROM AUTHOR]

Objective: Mirtazapine and SSRIs are widely prescribed as first-line agents for late-life depression. However, evidence for these drugs is mostly based on non-elderly patients. Therefore, we reanalyzed a randomized controlled trial of mirtazapine versus SSRIs for depression in a sub-population of late-life patients. Methods: A randomized controlled trial was conducted with 141 patients, of whom 41 were elderly, and 100 were non-elderly. This study compared SSRIs and mirtazapine in late-life depression, examined late-onset and early adult-onset separately and compared elderly and non-elderly patients for each drug. Treatment effects and adverse events were assessed using the Hamilton Depression Rating Scale and the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale, respectively. Results: In late-life depression, mirtazapine showed faster HAM-D total score improvement (3.3 points difference, p = 0.021) and higher improvement in insomnia (1.7 points difference, p = 0.001) and appetite (1.2 points difference, p = 0.020). Similar findings were observed for late-onset depression with the HAM-D total score (4.3 points difference, p = 0.007) and appetite (0.9 points difference, p = 0.004), favoring mirtazapine. Depressive symptoms were generally less improved in late-life depression than in non-late-life depression. Regarding the effect of mirtazapine on appetite, late-life depression showed greater improvement (0.7 points difference, p = 0.008). Nausea and micturition disturbances were more common with SSRIs in late-life depression than in non-late-life depression. In contrast, somnolence was less common in late-life depression with mirtazapine. Conclusion: The potential usefulness of mirtazapine in elderly patients was demonstrated. The results also showed differences in the treatment response to SSRIs and mirtazapine between elderly and non-elderly patients. [ABSTRACT FROM AUTHOR]

Background: Postpartum depression (PPD) affects up to one in five mothers and birthing parents, yet as few as 10% access evidence-based treatment. One-day cognitive behavioral therapy (CBT)-based workshops for PPD have the potential to reach large numbers of sufferers and be integrated into stepped models of care. Methods: This randomized controlled trial of 461 mothers and birthing parents in Ontario, Canada with Edinburgh Postnatal Depression Scale (EPDS) scores ⩾10, age ⩾18 years, and an infant <12 months of age compared the effects of a 1-day CBT-based workshop plus treatment as usual (TAU; i.e. care from any provider(s) they wished) to TAU alone at 12-weeks post-intervention on PPD, anxiety, the mother–infant relationship, offspring behavior, health-related quality of life, and cost-effectiveness. Data were collected via REDCap. Results: Workshops led to meaningful reductions in EPDS scores (m = 15.77 to 11.22; b = −4.6, p < 0.01) and were associated with three times higher odds of a clinically significant decrease in PPD [odds ratio (OR) 3.00, 95% confidence interval (CI) 1.93–4.67]. Anxiety also decreased and participants had three times the odds of clinically significant improvement (OR 3.20, 95% CI 2.03–5.04). Participants reported improvements in mother–infant bonding, infant-focused rejection and anger, and effortful control in their toddlers. The workshop plus TAU achieved similar quality-adjusted life-years at lower costs than TAU alone. Conclusions: One-day CBT-based workshops for PPD can lead to improvements in depression, anxiety, and the mother–infant relationship and are cost-saving. This intervention could represent a perinatal-specific option that can treat larger numbers of individuals and be integrated into stepped care approaches at reasonable cost. [ABSTRACT FROM AUTHOR]

Objective: Limited studies have yet evaluated the effectiveness of topiramate in the treatment of amphetamine and methamphetamine addiction. Therefore, the aim of this study was to investigate the effectiveness of topiramate in the treatment of patients with this disorder. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 52 patients with amphetamine and methamphetamine use disorder, within the age range of 16-60 years, were randomly divided into an intervention group (n = 26) and a placebo group (n = 26). The intervention group was treated with topiramate tablets with a starting dose of 50 mg, which was gradually increased to the target dose of 200 mg. The control group was treated with placebo. The duration of drug intervention in this clinical trial was 12 weeks, and all participants were evaluated before the intervention and 2, 4, 6, 8, 10, and 12 weeks after beginning the intervention. The Beck Depression Inventory, drug use temptation questionnaire, urine test, and side effects questionnaire were used as outcome measures to assess the patients. The data were analyzed using chi-square, independent t-test, and analysis of variance with repeated measurements. Results: There was no significant difference between the intervention and placebo groups in depression at the beginning of the treatment and at the 4th, 8th, and 12th weeks after the intervention (P > 0.05). The urine test also showed no significant difference between the two groups at any of the evaluation stages (P > 0.05). Although there was no significant difference between the two groups in the drug use temptation results at the beginning and the 2nd, 4th and 6th weeks (P > 0.05), the level of drug temptation in the intervention group was significantly lower than the placebo group in the 8th, 10th, and 12th weeks (P < 0.05). Conclusion: Topiramate can be effective in reducing the desire to use amphetamine and methamphetamine. However, further studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Purpose: To explore the theoretical constructs that functioned as mediators of interventions for moderate-to-vigorous physical activity (MVPA) maintenance among breast cancer survivors. Method: 161 survivors were randomized into 3 groups: Reach Plus, Reach Plus Message or Reach Plus Phone. All participants received a 3-month theory-based intervention delivered by volunteer coaches. During months 4–9, all participants monitored their MVPA and received feedback reports. Additionally, Reach Plus Message received weekly text/email messages and Reach Plus Phone received monthly calls from their coaches. Assessments of weekly MVPA minutes and theoretical constructs (self-efficacy, social support, physical activity [PA] enjoyment and PA barriers) were obtained at baseline, 3, 6, 9 and 12-months. Analyses: Using a multiple mediator analysis with a product of coefficients approach, we examined mechanisms associated with between-group differences over time in weekly MVPA minutes. Results: Self-efficacy mediated effects of Reach Plus Message vs. Reach Plus at 6 (ab = 16.99) and 9 M (ab = 27.45); social support mediated effects at 6 (ab = 4.86), 9 (ab = 14.30) and 12 M (ab = 6.18). Self-efficacy mediated effects of Reach Plus Phone vs. Reach Plus at 6 (ab = 18.76), 9 (ab = 28.93) and 12 M (ab = 18.18). Social support mediated effects of Reach Plus Phone vs. Reach Plus Message at 6 (ab=-5.50) and 9 M (ab=-13.20); PA enjoyment mediated effects at 12 M (ab=-3.63). Conclusions: PA maintenance efforts should focus on strengthening breast cancer survivors' self-efficacy and obtaining social support. The trial was registered at ClinicalTrials.Gov: NCT02694640 (Feb. 26, 2016). [ABSTRACT FROM AUTHOR]

Aims Burns and wounds caused by it are a global injury. Finding natural ingredients to accelerate wound healing in patients with fewer side effects could be valuable. This study aimed to determine the effect of oral Centella asiatica extract on the healing of pain and wound of burn in patients. Materials & Methods This study is a clinical trial in which 76 patients hospitalized in the burn department were randomly divided into two intervention (n=38) and control (n=38) groups. The intervention group, in addition to the usual antibiotic treatments, received capsules containing 200mg of Centella asiatica twice daily, and the control group received capsules containing 200mg of starch twice daily. Data collection tools were Bates-Jensen Wound Assessment tool and Visual Analog Scale. Patients' pain and wound healing status were examined at different time of the study. Findings The mean burn pain score showed a significant improvement in the intervention group compared to the control group (p<0.001). The average wound healing score did not show significant improvement in the intervention group compared to the control group (p=0.561). However, size (p=0.023), the degree of destruction of the underlying tissues (p=0.032), the amount of necrotic tissue (p=0.015), and the amount of granulation tissue (p=0.001) improved significantly in the intervention group. In addition, the peripheral tissue edema in the control group decrease significantly compared to the intervention group (p=0.008). Conclusion Oral extract of Centella asiatica reduces pain in burn patients. However, it does not affect wound healing, although it improves some wound healing indicators. [ABSTRACT FROM AUTHOR]

Objective: To optimize treatment recommendations for eating disorders, it is important to investigate whether some individuals may benefit more (or less) from certain treatments. The current study explored predictors and moderators of an automated online self‐help intervention "Featback" and online support from a recovered expert patient. Methods: Data were used from a randomized controlled trial. For a period of 8 weeks, participants aged 16 or older with at least mild eating disorder symptoms were randomized to four conditions: (1) Featback, (2) chat or e‐mail support from an expert patient, (3) Featback with expert‐patient support, and (4) a waitlist. A mixed‐effects partitioning method was used to see if age, educational level, BMI, motivation to change, treatment history, duration of eating disorder, number of binge eating episodes in the past month, eating disorder pathology, self‐efficacy, anxiety and depression, social support, or self‐esteem predicted or moderated intervention outcomes in terms of eating disorder symptoms (primary outcome), and symptoms of anxiety and depression (secondary outcome). Results: Higher baseline social support predicted less eating disorder symptoms 8 weeks later, regardless of condition. No variables emerged as moderator for eating disorder symptoms. Participants in the three active conditions who had not received previous eating disorder treatment, experienced larger reductions in anxiety and depression symptoms. Discussion: The investigated online low‐threshold interventions were especially beneficial for treatment‐naïve individuals, but only in terms of secondary outcomes, making them well‐suited for early intervention. The study results also highlight the importance of a supportive environment for individuals with eating disorder symptoms. Public Significance: To optimize treatment recommendations it is important to investigate what works for whom. For an internet‐based intervention for eating disorders developed in the Netherlands, individuals who had never received eating disorder treatment seemed to benefit more from the intervention than those who had received eating disorder treatment, because they experienced larger reductions in symptoms of depression and anxiety. Stronger feelings of social support were related to less eating disorder symptoms in the future. [ABSTRACT FROM AUTHOR]

Background: Emergence delirium (ED) is generally occurred after anesthesia associated with increased risks of long-term adverse outcomes. Therefore, this study aimed to evaluate the efficacy of preconditioning with nasal splint and mouth-breathing training on prevention of ED after general anesthesia. Methods: This randomized controlled trial enrolled 200 adult patients undergoing ESS. Patients were randomized to receive either nasal splinting and mouth breathing training (n = 100) or standard care (n = 100) before surgery. The primary outcome was the occurrence of ED within 30 min of extubation, assessed using the Riker Sedation-Agitation Scale. Logistic regression identified risk factors for ED. Results: Totally 200 patients were randomized and 182 aged from 18 to 82 years with 59.9% of males were included in the final analysis (90 in C-group and 92 in P-group). ED occurred in 16.3% of the intervention group vs. 35.6% of controls (P = 0.004). Male sex, smoking and function endoscopic sinus surgery (FESS) were independent risk factors for ED. Conclusions: Preoperative nasal splinting and mouth breathing training significantly reduced the incidence of emergence delirium in patients undergoing endoscopic sinus surgery. Trial Registration: ChiCTR1900024925 (https://www.chictr.org.cn/index.aspx) registered on 3/8/2019. [ABSTRACT FROM AUTHOR]

Introduction: Therapy of proliferative lupus nephritis (PLN) is yet to be optimized. Standard of care for induction consists of intravenous (IV) cyclophosphamide (CYC) and steroids, which shows an improved outcome, but end-stage renal disease (ESRD) progression, increased mortality, and therapy-related adverse effects remain a major concern. The other treatment reported to induce early remission was the multitarget therapy comprising tacrolimus, mycophenolate, and steroid, but infections were high in the multitarget therapy. Considering azathioprine as a potentially safer and effective alternative anti-B-cell therapy, modified multitarget therapy (MMTT) was planned replacing mycophenolate with azathioprine. Material and Methods: A single-center, 24-week, open-label, randomized controlled trial comprising adults of age 18-65 years with biopsy-proven PLN was carried out. The intervention groups were 1) MMTT: tacrolimus 0.075 mg/kg/day and azathioprine 2 mg/kg/day and 2) IV CYC group with a starting dose of 0.75 (adjusted to 0.5-1.0) g/m² every 4 weeks for 6 months. Both groups received 3 days of pulse methylprednisolone followed by a tapering course of oral prednisone therapy. Results: Among 100 randomized patients, 48 were in MMTT arm and 52 were in IV CYC arm. At the end of 24 weeks, overall remission (complete and partial) was comparable in both the arms: MMTT (86.36%) and IV CYC (87.75%). There was comparable proteinuria reduction and systemic lupus erythematosus disease activity index (SLEDAI) score improvement with recovery of complement level C3 in both groups. Major adverse events were numerically more in the IV CYC group, including one death from pneumonia. Conclusion: The MMTT arm is as effective as IV CYC in improving short-term outcome in PLN, with a comparable safety profile. [ABSTRACT FROM AUTHOR]

Objectives Although the painful and disabling features of early diffuse cutaneous SSc (dcSSc) have an inflammatory basis and could respond to corticosteroids, corticosteroids are a risk factor for scleroderma renal crisis. Whether or not they should be prescribed is therefore highly contentious. Our aim was to examine safety and efficacy of moderate-dose prednisolone in early dcSSc. Methods PRedSS set out as a Phase II, multicentre, double-blind randomized controlled trial, converted to open-label during the Covid-19 pandemic. Patients were randomized to receive either prednisolone (∼0.3 mg/kg) or matching placebo (or no treatment during open-label) for 6 months. Co-primary endpoints were the HAQ Disability Index (HAQ-DI) and modified Rodnan skin score (mRSS) at 3 months. Over 20 secondary endpoints included patient reported outcome measures reflecting pain, itch, fatigue, anxiety and depression, and helplessness. Target recruitment was 72 patients. Results Thirty-five patients were randomized (17 prednisolone, 18 placebo/control). The adjusted mean difference between treatment groups at 3 months in HAQ-DI score was −0.10 (97.5% CI: −0.29, 0.10), P  = 0.254, and in mRSS −3.90 (97.5% CI: −8.83, 1.03), P  = 0.070, both favouring prednisolone but not significantly. Patients in the prednisolone group experienced significantly less pain (P  = 0.027), anxiety (P  = 0.018) and helplessness (P  = 0.040) than control patients at 3 months. There were no renal crises, but sample size was small. Conclusion PRedSS was terminated early primarily due to the Covid-19 pandemic, and so was underpowered. Therefore, interpretation must be cautious and results considered inconclusive, indicating the need for a further randomized trial. Trial registration ClinicalTrials.gov , https://clinicaltrials.gov , NCT03708718. [ABSTRACT FROM AUTHOR]

Aims: To test the effectiveness of a digital intervention to reduce cannabis use (ICan) with adherence‐focused guidance compared with educational cannabis information. Design: This was a single‐blind randomized controlled trial. Follow‐up clinical outcome measurements took place 3 and 6 months after randomization. Setting: The trial was conducted in the Netherlands. The intervention and guidance took place on‐line, with recruitment via Facebook/Instagram advertisement campaigns. Participants: Inclusion criteria were ≥ 18 years, cannabis use on ≥ 3 days/week, the desire to reduce/quit cannabis and using a smartphone. Participants were allocated to either ICan (n = 188) or control (n = 190) (69% male, mean age = 27.5 years). Intervention and comparator: ICan is a mobile (web‐)application based on motivational interviewing and cognitive behavioural therapy and includes three main components: screening, brief intervention (six modules) and referral to treatment. The control condition consisted of non‐interactive educational cannabis information. Measurements Primary outcome was the number of cannabis use days in the 7 days prior to the 6‐month follow‐up measurement. Secondary outcome measures at 3‐ and 6‐month follow‐up were the number of grams of cannabis used and attitudes towards seeking professional help for cannabis use related problems. Findings Intention‐to‐treat analysis showed that 6 months after randomization the mean number of cannabis use days in the past 7 days was reduced in both conditions (time P < 0.001), with no significant group × time interaction effect [ICan = 4.17 days, control = 4.31 days, Cohen's dbetween = 0.06, 95% confidence interval (CI) = −0.15, 0.26, P = 0.93]. Three months after randomization the mean number of grams used in the past 7 days was reduced in both conditions, with a significantly larger reduction in the ICan condition (P = 0.009, Cohen's dbetween = 0.15). At 6‐month follow‐up the significant group × time interaction effect was no longer present (P = 0.30). In both conditions, attitudes towards seeking professional help remained virtually unchanged over time. Conclusions: A digital intervention to reduce cannabis use (ICan) was more effective than non‐interactive educational cannabis information in reducing grams of cannabis used over 3 months, but not more effective at reducing cannabis use days at 6‐month follow‐up. Cannabis use reductions were maintained in both conditions between 3 and 6 months' follow‐up. [ABSTRACT FROM AUTHOR]

Online interventions that elicit kindness may enhance well-being. We tested the efficacy of three kindness interventions among breast cancer survivors. Participants (N = 137, Mage = 62.65 years) were randomized to perform acts of kindness for others, acts of kindness for self, self-kindness meditation, or a daily-activities-writing control and completed three activities each week for 4 weeks. Primary (well-being, depressive symptoms) and secondary outcomes (social support, self-kindness) were assessed pre- and post-intervention. No differences emerged in the primary outcomes. However, relative to controls, participants in the acts of kindness to others condition reported greater increases in social support, and participants in the self-kindness meditation condition reported greater decreases in self-kindness. Among breast cancer survivors, performing prosocial acts may enhance feelings of social support. The two self-kindness conditions yielded either null or detrimental effects, suggesting that further research is needed on best practices for conducting self-focused kindness interventions. [ABSTRACT FROM AUTHOR]

To determine the efficacy of the "Training for Occupational health physicians To Involve Significant others" (TOTIS) e-learning module for improving occupational health physicians' (OHPs) knowledge, attitudes, and self-efficacy regarding involving significant others in the return-to-work process. A randomized controlled trial with 87 OHPs, involving an intervention group and a wait-listed control group. Between-group differences in knowledge, attitude, and self-efficacy outcomes, and retention of effects were assessed using ANOVA and paired t-tests. Reactions to the e-learning module were analyzed with descriptive statistics and thematic analysis. We found moderate to large effects on OHPs' knowledge (p < 0.001, ηp2 = 0.202), attitudes (p = 0.003, ηp2 = 0.098), and self-efficacy (p < 0.001, ηp2 = 0.237), with retention of all changes at 10-week follow-up. OHPs graded the e-learning module with a mean score of 7.9 out of 10 (SD = 1.11) and indicated that the module increased their awareness of the role of significant others and encouraged them to address this more often. The TOTIS e-learning module and accompanying materials are valuable resources for OHPs to learn how significant others influence work outcomes of workers with chronic diseases and to manage their involvement in the re-integration process. This study is registered in the Netherlands Trial Register under trial number NL8744; . The TOTIS e-learning module is the first evidence-based training to improve the knowledge, attitudes, and self-efficacy of occupational health physicians with regard to involving significant others in the re-integration process of workers with chronic diseases. The e-learning module and accompanying tools can increase the awareness of occupational health physicians about the role of significant others and encourage them to address the role of significant others in the re-integration process of sick-listed workers. It could be beneficial to expand on the e-learning module with a face-to-face training program involving group interaction, peer discussion, and skills development. [ABSTRACT FROM AUTHOR]

Background: Studies assessing the effects of parenting programs have focused on interventions delivered through face-to-face modalities. There is a need for research to evaluate the effects of online parenting programs on child development, such as the BEM Program ('Play Teaches Change' in English), an online play-based parenting program that teaches caregivers on how to introduce playful interactions into their daily household chores. Objective: To assess the effects of the BEM Program on child development and the quality of caregiver-child interaction. Method: A two-arm randomized controlled trial was conducted in a socioeconomically disadvantaged district of São Paulo city in Brazil. 129 children aged 12–23 months and their caregiver were randomly assigned to receive either the BEM Program for 8 weeks (intervention, n = 66) or standard child care (control, n = 63). Data were collected at baseline and endline of the intervention through home visits and online interviews. An intention-to-treat analysis was conducted. Results: The intervention showed positive effects on child development, by improving language development (Cohen's d = 0.20, 95%CI 0.08–0.47) and reduced intrusiveness (Cohen's d = 0.35, 95%CI 0.06–0.65) of caregiver-child interaction. No significant differences were observed in caregiver's repertoire and engagement in age-appropriate play activities with the child while doing the household chores, parenting sense of competence and perceived stress. Conclusions: Despite the small size and low adherence to the program, such promising results advance evidences for fully remote parenting programs and their effects on child development. [ABSTRACT FROM AUTHOR]

Background: The optimal allocation of training time to different intensities in cardiac rehabilitation is still under debate. The objective of this study was to explore whether in a 12‐week cardiac rehabilitation program, replacement of two of four usual continuous endurance training (CET) sessions per week with energy expenditure‐matched high‐intensity interval training (HIIT) affects the trajectories of cardiopulmonary exercise test (CPET) variables such as ventilatory equivalents for O2 (EqO2) and CO2 (EqCO2), and blood lactate (BLa) during CPET. Methods: Eighty‐two male patients undergoing outpatient cardiac rehabilitation after an acute coronary syndrome were randomized to CET (age [mean ± SD] 61.7 ± 9.8 years, body mass index [BMI] 28.1 ± 3.4) or HIIT+CET (60.0 ± 9.4 years, BMI 28.5 ± 3.5). CPET was performed at baseline, after 6 and after 12 weeks. HIIT consisted of ten 60‐s bouts of cycling at an intensity of 100% of the maximal power output (Pmax) achieved in an incremental test to exhaustion, interspersed with 60 s at 20% Pmax. CET was performed at 60% Pmax with equal duration. Training intensities were adjusted after 6 weeks to account for the training‐induced improvement in cardiorespiratory fitness. The entire functions defining the relationship between EqO2, EqCO2, and BLa, with power output were modeled using linear mixed models to assess how these trajectories are affected by HIIT. Results: After 6 and 12 weeks, Pmax increased to 112.9% and 117.5% of baseline after CET, and to 113.9% and 124.7% after HIIT+CET (means). Twelve weeks of HIIT+CET elicited greater reductions of EqO2 and EqCO2 than CET alone (p < 0.0001 each) in a range above 100% baseline Pmax. Specifically, at 100% of baseline Pmax, least squares arithmetic mean EqO2 values of CET and HIIT+CET patients were 36.2 versus 33.5. At 115% and 130% of baseline Pmax, EqO2 values were 41.2 versus 37.1 and 47.2 versus 41.7. Similarly, corresponding EqCO2 values of CET and HIIT+CET patients were 32.4 versus 31.0, 34.3 versus 32.2, and 37.0 versus 34.0. Conversely, mean BLa levels (mM) were not differently affected (p = 0.64). At 100%, 115%, and 130% of baseline Pmax after 12 weeks, BLa levels did not differ to a relevant extent (least squares geometric means, 3.56 vs. 3.63, 5.59 vs. 5.61, 9.27 vs. 9.10). Conclusions: While HIIT+CET reduced ventilatory equivalents more effectively than CET alone, specifically when patients were approaching their maximal performance during CPET, both training strategies were equally effective in reducing BLa levels. [ABSTRACT FROM AUTHOR]

Background: The risk of postoperative cognitive dysfunction(POCD) in laparoscopic surgery should not be overlooked. Intravenous lidocaine can reduce perioperative inflammatory response in patients undergoing laparoscopic surgery, while the effect of intraoperative intravenous lidocaine on postoperative cognitive function in patients undergoing laparoscopic colorectal cancer surgery has not been well studied. We investigated whether intraoperative lidocaine improves postoperative cognitive function after laparoscopic radical resection for colorectal cancer. Methods: We conducted a prospective, randomized double blinded controlled trial to investigate the effect of intravenous lidocaine on rapid postoperative recovery in patients undergoing laparoscopic radical resection of colorectal cancer. The patients were randomly assigned to receive either intravenous lidocaine or saline. The primary outcome was cognitive dysfunction defined by a decrease from pre- to postoperative ≥ 2 of the Mini-Mental State Examination (MMSE) score, at the 3rd and the 7th postoperative days. Secondary outcomes were the MMSE raw score and parameters of the patients' postoperative recovery such as agitation and length of stay in the post-anaesthesia care unit (PACU), length of hospital stay, markers of inflammation (white blood cell count and CRP), and incidence of complications. Results: Seventy-three patients in the lidocaine group and 77 patients in the control group completed the trial. The rate of cognitive dysfunction was lower in the lidocaine group than that in the control group, both at the 3rd (18.57% vs. 63.64% for each group respectively; RR = 0.26, 95%CI = 0.19–0.32; p < 0.0001) and at the 7th postoperative day (12.33% vs. 53.25% for each group respectively; RR = 0.28, 95%CI = 0.22–0.35; P < 0.001). The postoperative MMSE scores were also higher in the lidocaine group than in the control group both at the 3rd (median 25 vs. 24 respectively) and at the 7th postoperative day (26 vs. 24 respectively). Also, patients in the lidocaine group displayed a lower white blood cell count than the control group at the 1st postoperative day (8.5 ± 2.7 vs. 10.4 ± 3.3; p < 0. 001). No differences were evidenced for the other secondary outcomes. Conclusions: Intraoperative intravenous lidocaine can significantly improve postoperative cognitive function in patients undergoing laparoscopic radical resection of colorectal cancer. Trial registration: Chinese Clinical Trial Registry (16/1/2022, registration number: ChiCTR2200055683) [ABSTRACT FROM AUTHOR]

Background: The long-term outcome of first-episode schizophrenia needs improvement. Here, we evaluate the effectiveness of 5 years sustained specialist treatment (ST), ST including Parent groups (ST + P) or treatment as usual (TAU) on psychotic relapse and social functioning. Methods: A three condition randomized, parallel assigned, single-blind efficacy trial, in which 198 first-episode psychosis (FEP) patients aged 15–28 years were included. The effect on time to first relapse, first relapse rates, mean number of relapses per patient, and time to the improvement of social functioning were analyzed using Cox regression or ANOVA. Results: We found no significant differences between treatment conditions in the ITT analysis concerning time to first relapse, nor first relapse rate. Mean number of relapses per patient differed at a trend level between ST, ST + P or TAU conditions, respectively: 0.72; 0.62 or 1.02 (p = 0.069). No evidence was found for differential effect of treatment conditions on social functioning. Conclusion: Five years sustained ST of FEP nor addition of parent groups increased time to first relapse or reduced first relapse rate, compared to sustained TAU. Indications for favorable effects of parent groups were found on relapses per patient. [ABSTRACT FROM AUTHOR]

Background: Knee osteoarthritis (KOA) is a common degenerative joint condition that causes disability and pain in the elderly population. The prevalence of KOA among persons aged 63 or above is approximately 30%. Previous studies have reported the positive effects of Tui-na treatment and the Chinese herbal formula Du-Huo-Ji-Sheng Decoction (DHJSD) for KOA treatment. The current study aims to evaluate the add-on therapeutic effect of oral administration of DHJSD on KOA in addition to Tui-na. Methods: We conducted a prospective, randomized, controlled clinical trial. Seventy study subjects with KOA were randomly assigned to the treatment and control groups in a 1:1 ratio. Both two groups received eight sessions of Tui-na manipulation for 4 weeks. The DHJSD was only administered to the study subjects in the treatment group. The primary outcome measure was rated using the WOMAC at the end of treatment (4 weeks). Secondary outcomes were assessed using EQ-5D-5L, a health-related quality of life with 5-level EQ-5D version at end of treatment (week 4) and follow-up (week 8). Results: No statistically significant difference was found between two groups on WOMAC scores at the end of treatment. The mean WOMAC Pain subscale score was significantly lower in the treatment group than control group at week 8 follow up (mean difference, MD − 1.8, 95% CI − 3.5 to − 0.02, P = 0.048). The mean WOMAC Stiffness subscale score was significantly lower in the treatment group than in the control group at week 2 (MD 0.74, 95% CI 0.05 to 1.42, P = 0.035) and week 8 follow up (MD 0.95, 95% CI 0.26 to 1.65, P = 0.008). The mean EQ-5D index value was significantly improved in the treatment group than in the control group at week 2 (MD 0.17, 95% CI 0.02 to 0.31, P = 0.022). The analysis of WOMAC scores and EQ-5D-5L in both groups showed statistically significant improvement with time. No significant adverse effect was found during the trial. Conclusion: DHJSD may have an add-on effect in addition to Tui-na manipulation relieving pain and improving stiffness as well as quality of life (QOL) in patients with KOA. The combined treatment was generally safe and well tolerated. Trial registration The study was registered at the ClinicalTrials.gov (website: https://clinicaltrials.gov/ct2/show/NCT04492670, registry number: NCT04492670), registered on 30 July 2020. [ABSTRACT FROM AUTHOR]

Aims: People living with HIV are at a high risk for cardiovascular disease owing to antiretroviral therapy use and chronic inflammation. There is limited evidence on the evaluation of serum lipid levels through lifestyle modification. This study aims to evaluate the effect of a smartphone application‐based diet and exercise improvement program on men living with HIV and dyslipidemia. Methods: This was a randomized controlled trial recruiting Japanese men living with HIV who have dyslipidemia: intervention group (n = 19) and control group (n = 19). The intervention group received a third individual guidance session during the 6‐month intervention and was encouraged to record their diet on a smartphone application. An intention‐to‐treat analysis of the results was conducted. Results: The intervention group showed significantly reduced change in low‐density lipoprotein levels compared to the control group (−4.00 ± 20.2 mg/dL vs. 10.11 ± 21.1 mg/dL) (p =.042) from baseline to 6 months post‐intervention. No significant differences were found in other serum lipid levels. Abdominal circumference decreased significantly in the intervention group (p =.048) from baseline to 6 months post‐intervention. Total energy, protein, carbohydrate, fat, and salt intake, dietary and physical activity behavior change stages and social support, dietary self‐efficacy, and loneliness significantly improved in the intervention group (p <.05) from baseline to 6 months post‐intervention. Conclusions: A diet and physical activity improvement program using a smartphone application based on Japanese‐specific health guidance may reduce low‐density lipoprotein cholesterol levels in this population. Further sample expansion and examination of long‐term effects are needed. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to investigate the effectiveness of solution-focused group counseling (SFGC) to reduce depressive symptoms and improve cognitive functions among Chinese rural older adults. Method: In a cluster randomized controlled trial, 290 participants were randomly assigned to a 12-session SFGC intervention or a control group. the Center for Epidemiological Studies Depression Scale and Mini-Mental State Examination was adopted to measure depressive symptoms and cognitive functions, respectively, at pretest and posttest. Results: Repeated measure ANOVAs showed a significant group by time effect for both measures. Paired sample t-tests showed that depressive symptoms significantly decreased in the intervention group, but not in the control group. Cognitive functions did not change in the intervention group, but significantly declined in the control group. Conclusions: Our findings support the feasibility and effectiveness of a culturally adapted SFGC for reducing depressive symptoms and protecting cognitive functions among the disadvantaged older adults in a developing country. [ABSTRACT FROM AUTHOR]

Background and Aims: Most alcohol‐dependent people have a moderate level of dependence. General practitioners (GPs) hesitate to engage in this area, and need to have access to treatment they find applicable and feasible to use. The aim of this present study was to test if an open‐ended internet‐based cognitive–behavioral therapy (iCBT) program added to treatment‐as‐usual (TAU) is more effective than TAU‐only for alcohol‐dependent patients in primary care. Design, Setting and Participants: The present study was a two‐group, parallel, randomized controlled superiority trial comparing iCBT+TAU versus TAU‐only at 3‐ and 12‐month follow‐ups. TAU was delivered at 14 primary care centers in Stockholm, Sweden. A total of 264 patients (mean age 51 years, of whom 148 were female and 116 were male) with alcohol dependence and hazardous alcohol consumption were enrolled between September 2017 and November 2019. Measurements: Participants were randomized at a ratio of 1:1 to iCBT, as a self‐help intervention added to TAU (n = 132) or to TAU‐only (n = 132). The GPs gave participants in both treatment arms feedback on the assessments and biomarkers and offered TAU at the primary care center. Primary outcome was weekly alcohol consumption in g/week at 12‐month follow‐up, analyzed according to intention‐to‐treat (n = 132 + 132). The per‐protocol analysis included participants who completed at least one module of iCBT (n = 102 + 132). Findings There was no significant difference in weekly alcohol consumption between iCBT+TAU and TAU in the intention‐to‐treat (ITT) analysis at 12‐month follow‐up [iCBT+TAU = 133.56 (95% confidence interval, CI = 100.94–166.19) and TAU = 176.20 (95% CI = 144.04–208.35), P = 0.068, d = 0.23]. In the per‐protocol analysis, including only those who initiated iCBT, the iCBT+TAU group showed lower mean weekly alcohol consumption compared with TAU [iCBT+TAU = 107.46 (95% CI = 71.17–143.74), TAU = 176.00 (95% CI = 144.21–207.80), P = 0.010, d = 0.42]. Conclusions: In Sweden, an internet‐based cognitive–behavioral program added to treatment‐as‐usual to reduce alcohol consumption showed weak evidence of a benefit at 12 months in the intention‐to‐treat analysis and good evidence of a benefit in the per‐protocol analysis. [ABSTRACT FROM AUTHOR]