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Postpartum depression (PPD) poses significant challenges, affecting both mothers and children, with substantial societal and economic implications. Internet-based cognitive behavioral therapy interventions (iCBT) offer promise in addressing PPD, but their economic impact remains unexplored. This study aimed to evaluate the cost-utility of Be a Mom, a self-guided iCBT intervention, compared with a waiting-list control among postpartum women at high risk of PPD. This economic evaluation was conducted alongside a 14-month randomized controlled trial adopting a societal perspective. Participants were randomized to Be a Mom (n = 542) or a waitlisted control group (n = 511). Self-report data on healthcare utilization, productivity losses, and quality-adjusted life years (QALYs) were collected at baseline, post-intervention, and 4 and 12 months post-intervention. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness acceptability curves were generated using nonparametric bootstrapping. Sensitivity analyses were conducted to assess result robustness. Over 14 months, Be a Mom generated a QALY gain of 0.0184 (0.0022, 0.0346), and cost savings of EUR 34.06 (−176.16, 108.04) compared to the control group. At a willingness to pay of EUR 20,000, Be a Mom had a 97.6 % probability of cost-effectiveness. Results have limitations due to self-selected sample, potential recall bias in self-reporting, missing data, limited follow-up, and the use of a waiting-list control group. This study addresses a critical gap by providing evidence on the cost-utility of an iCBT intervention tailored for PPD prevention. Further research is essential to identify scalable and cost-effective interventions for reducing the burden of PPD. • First randomized trial on cost-utility of iCBT for prevention of PPD • Compared to the control group, the intervention yielded more QALYs and less costs over 14 months. • The intervention had a 97.6 % probability of cost-effectiveness at a WTP of EUR 20,000. • iCBT has the potential to be adopted as a cost-effective preventive strategy for PPD. [ABSTRACT FROM AUTHOR]

In an inpatient treatment center for pediatric obesity, the effectiveness of an emotion regulation (ER) training on top of the multidisciplinary obesity treatment (MOT) was tested by means of an RCT. The ER training was evaluated on primary outcomes: ER and emotional eating, and secondary outcomes: well-being and weight loss, taking into account pre, post, and follow-up measurements. Of the 115 10- to-14-year old adolescents with obesity (52.2% girls), 65 were allocated to the ER training. Physicians measured their height and weight objectively (4 times). Participants also filled out questionnaires on ER competencies (ER abilities and ER strategies), emotional eating and well-being (3 times). Significant pre-post interactions were found for "emotional awareness," "problem solving," and "evoking a positive mood." Moreover, the positive effects of the ER training on emotion regulation strategies were maintained at follow-up. Concerning well-being, no significant pre-post interaction effects were found but a significant interaction effect was found when comparing pre with follow-up. Analyses show a significant main effect of time on weight loss, but this was not qualified by a Time × Condition interaction effect. The current RCT study shows limited but promising effects of adding an ER training to the MOT. Further research should investigate whether the positive short-term effects will be maintained. [ABSTRACT FROM AUTHOR]

Pregnant women often experience anxiety due to pregnancy, negatively impacting their and their fetus' health. Non-pharmacological interventions, such as virtual reality (VR), could reduce anxiety levels, potentially impacting non-stress tests or the physiological responses of the pregnant woman and the fetus. A randomized clinical trial conducted between February and December 2022 involved 286 term pregnant women. They were divided into a VR intervention group (146 women) and a control group (140 women). The intervention consisted of 20 min of 3D glasses with images and sounds during a third-trimester nonstress test. Anxiety was measured using the Spielberg State-Trait Anxiety Inventory (STAI), alongside physiological parameters. The VR group exhibited lower anxiety levels compared to controls (STAI score: Rosenthal's r: −0.54, p = 0.01; state anxiety: Rosenthal's r: −0.40, p = 0.001; trait anxiety: Rosenthal's r: −0.41, p = 0.001). Within the VR group, there was a significant reduction in trait anxiety (Rosenthal's r, 1.27; p < 0.001) and total anxiety (Rosenthal's r, 1.63; p < 0.001) post-intervention, along with decreased systolic blood pressure (p < 0.001), diastolic blood pressure (p < 0.001), and maternal heart rate (p = 0.02). Future research could explore additional pregnancy-related variables, such as postpartum anxiety. The results confirm that the use of VR is beneficial for pregnant women and their fetuses, as it decreases anxiety levels, and improves physiological parameters such as blood pressure and maternal heart rate during the nonstress test. VR is a technique that is easy to integrate into the healthcare system due to its non-invasive and non-pharmacological nature. • Virtual reality has proven to be an effective technique in reducing anxiety of pregnant women during NST. • Anxiety is related to higher blood pressure and heart rate values in pregnant women during NST. • Blood pressure and heart rate in pregnant women improved when virtual reality was used as a therapy. [ABSTRACT FROM AUTHOR]

Depressed patients who have become victim of violence are prone to revictimization. However, no evidence-based interventions aimed at reducing revictimization in this group exist. This multicenter randomized controlled trial evaluated the effectiveness of an internet-based emotion regulation training (iERT) added to TAU in reducing revictimization, emotion dysregulation, and depressive symptoms in recently victimized, depressed patients compared to TAU alone. Adult outpatients (N = 153) with a depressive disorder who had experienced threat, physical assault, or sexual assault within the previous three years were randomly allocated to TAU+iERT (n = 74) or TAU (n = 79). TAU involved psychotherapy (mainly cognitive behavioral therapy [77.8 %]). iERT comprised six guided online sessions focused on the acquisition of adaptive emotion regulation skills. The primary outcome measure was the number of revictimization incidents at 12 months after baseline, measured with the Safety Monitor. Analyses were performed according to the intention-to-treat principle. Both groups showed a large decrease in victimization incidents. Mixed-model negative binomial regression analyses showed that TAU+iERT was not effective in reducing revictimization compared to TAU (IRR = 0.97; 95%CI = 0.64,1.46; p =.886). Linear mixed-model analyses demonstrated that TAU+iERT yielded a larger reduction of emotion dysregulation (B = −7.217; p =.046; Cohens d = 0.33), but not depressive symptoms (B = −1.041; p =.607) than TAU. The study was underpowered to detect small treatment effects. Additionally, uptake of iERT was quite low. Although TAU+iERT resulted in a larger decrease of emotion dysregulation than TAU alone, it was not effective in reducing revictimization and depressive symptoms. Patients' revictimization risk substantially decreased during psychotherapy. • Online emotion regulation training improved emotion regulation in depressed patients. • iERT did not reduce revictimization rates or depressive symptoms compared to TAU. • Violent victimization rates decreased substantially during psychotherapy. [ABSTRACT FROM AUTHOR]

The pathophysiology and the potential risks of placental transfusion (PT) differ substantially in preterm infants, necessitating specific studies in this population. This study aimed to evaluate the safety and efficacy of PT in preterm infants from the perspective of long-term neurodevelopmental outcomes. We conducted a systematic literature search using placental transfusion, preterm infant, and its synonyms as search terms. Cochrane Central Register of Controlled Trials, Medline, and Embase were searched until March 07, 2023. Two reviewers independently identified, extracted relevant randomized controlled trials, and appraised the risk of bias. The extracted studies were included in the meta-analysis of long-term neurodevelopmental clinical outcomes using fixed-effects models. A total of 5612 articles were identified, and seven randomized controlled trials involving 2551 infants were included in our meta-analysis. Compared with immediate cord clamping (ICC), PT may not impact adverse neurodevelopment events. No clear evidence was found of a difference in the risk of neurodevelopmental impairment (risk ratio [RR]: 0.89, 95% confidence interval [CI]: 0.76 to 1.03, P = 0.13, I2 = 0). PT was not associated with the incidence of cerebral palsy (RR: 1.23, 95% CI: 0.59 to 2.57, P = 0.79, I2 = 0). Analyses showed no differences between the two interventions in cognitive, language, and motor domains of neurodevelopment. From the perspective of long-term neurodevelopment, PT at preterm birth may be as safe as ICC. Future studies should focus on standardized, high-quality clinical trials and individual participant data to optimize cord management strategies for preterm infants after birth. [ABSTRACT FROM AUTHOR]

Subjective support could ameliorate the adverse effect of (pre)frailty on depressive symptoms. However, there is scarce evidence regarding subjective support-focused intervention in preventing depression among (pre)frail community-dwelling older adults. This study aims to explore the effectiveness of subjective support-focused cognitive behavioral therapy (SS-CBT) in preventing depression among this group of population. A total of 100 community-dwelling (pre)frail older adults were recruited from six communities in a Chinese city and were randomized to an 8-week SS-CBT group or a wait-list control group. Depressive symptoms and subjective support were assessed at baseline (T0), and at 8 week (T1), 12 week (T2), 16 week (T3) after randomization. Generalized estimating equation was used to examine the effectiveness of SS-CBT on depressive symptoms and subjective support. Hierarchical linear regression models and Bootstrapping method were used to examine whether subjective support mediated the effectiveness of SS-CBT on depressive symptoms. Participants in SS-CBT group reported significant reduction in depressive symptoms (Wald χ 2 = 20.800, p < 0.001) and improvement in subjective support (Wald χ 2 = 92.855, p < 0.001) compared to those in wait-list control group. Changes in subjective support mediated the effectiveness of SS-CBT on changes in depressive symptoms. Restricted regions to recruit participants, inclusion of the most motivated participants, lack of diagnosis of depression, potential experimenter bias and contamination, short follow-up period, and lack of an active control group. The findings support the benefits of SS-CBT in preventing depression among (pre)frail community-dwelling older adults, and provide insight into possible mechanisms. • (Pre)frail older adults are more likely to experience depression. • Subjective support is effective in protecting depression. • Cognitive behavioral therapy has the potential to improve subjective support. [ABSTRACT FROM AUTHOR]

We evaluated if Insulin-like Factor 3, basal and human chorionic gonadotropin (hCG)-stimulated testosterone could predict beneficial effects of testosterone replacement among 69 testicular cancer survivors with mild Leydig cell insufficiency randomly assigned to testosterone replacement therapy or placebo. Although the patients with Insulin-like Factor 3 and hCG-stimulated testosterone below median at baseline had less fat mass after 12 months of testosterone replacement therapy compared with placebo, we cannot recommend testosterone replacement therapy in specific subgroups of men with mild Leydig cell insufficiency. Introduction: Mild Leydig cell insufficiency affects a substantial proportion of testicular cancer survivors. Previous studies have not shown a beneficial effect of testosterone replacement therapy, however, with a pronounced interindividual effect. Thus, biomarkers identifying the subgroups that might benefit are wanted. We aimed to determine if insulinlike factor 3 (INSL3), basal and human chorionic gonadotropin (hCG)-stimulated testosterone can predict the effect of testosterone replacement therapy in testicular cancer survivors with mild Leydig cell insufficiency. Patients and Methods: We randomized adult testicular cancer survivors with mild Leydig cell insufficiency 1:1 to 12 months of transdermal testosterone replacement therapy (Tostran gel 2%) or placebo. INSL3, basal, and hCG-stimulated testosterone were measured at baseline. Outcomes (glucose, insulin, HbA1C, lipids, blood pressure, and body composition) were measured at baseline, 6 and 12 months. We applied a linear mixed-effect model comparing patients receiving testosterone with placebo in subgroups by biomarker. Results: We included and randomized 69 patients between October 2016 and February 2018. Patients with INSL3 and hCG-stimulated testosterone concentrations below the median had a -1.7 kg (95% CI: -3.1, -0.4) and -2.0 kg (95% CI: -3.5, -0.6) change in fat mass after 12 months of testosterone replacement therapy compared with placebo. This was not the case in patients with INSL3 and hCG-stimulated testosterone above the median. We did not find any effect of these biomarkers on glucose, insulin, HbA1c, or lipids. Conclusion: Patients with INSL3 and hCG-stimulated testosterone concentrations below the median had decreased fat mass after 1 12 months of testosterone replacement therapy compared with placebo. It should be evaluated in larger trials if these biomarkers can be used as predictive markers identifying testicular cancer patients with mild Leydig cell insufficiency who might benefit from testosterone substitution. [ABSTRACT FROM AUTHOR]

As the prevalence of tramadol toxicity is increasing, managing these patients with the aim of treatment and complete recovery has become a major challenge for health care professionals. This study evaluated the short-term effects of IV lipid emulsion (ILE) administration in cases of tramadol poisoning. In this double-blind, randomized controlled trial, 120 patients with pure tramadol poisoning and a Glasgow Coma (GCS) score ≤ 12 referred to a poisoning center in Tehran, Iran were selected and randomly assigned 1:1 to receive ILE 20% (intervention) or 0.9% saline (control) after admission and primary stabilization. The patient's vital signs, GCS score, hospitalization duration, and rate of seizure occurrence were recorded and compared between the two groups. Mean (SD) age of participants was 25.3 (5.4) years and 84 (70%) were male. Mean (SD) ingested dose of tramadol was 3118 (244) mg, which was not different between the groups. Compared with controls, the ILE group had a higher level of consciousness after treatment (median [interquartile range] GCS score 12 [10–13] vs. 10 [8–12]; p = 0.03). In addition, length of hospitalization (median [interquartile range] (2 [1–3] days vs. 4 [4–6] days; p < 0.01) and rate of seizure occurrence were lower in the intervention group (16/60 vs. 30/60; p < 0.01). In the setting of tramadol poisoning with a decreased level of consciousness and based on our study's findings, administration of ILE is suggested to help manage patients in hospital emergency departments. However, larger trials might be needed to confirm these findings before entering the guidelines. [ABSTRACT FROM AUTHOR]

Up to 79 % of older adults with depression do not receive treatments commensurate with guideline recommendations. Metacognitive Training-Silver (MCT-Silver) is a low-intensity group training, which aims to reduce depressive symptoms by targeting (meta)cognitive beliefs. A randomized controlled trial comparing MCT-Silver (n = 41) to cognitive remediation (n = 39) was conducted with older adults with major depressive disorder and/or dysthymia. Clinician-rated depression (Hamilton Depression Rating Scale [HDRS, primary outcome]), self-reported depression (Beck Depression Inventory-II [BDI-II]), negative cognitive beliefs, positive metacognitive beliefs, rumination, health status, quality of life, and neurocognitive functioning were assessed at baseline, eight weeks (post) and three months (follow-up). Both groups demonstrated moderate to large reductions in depression. No superior effects of MCT-Silver on clinician-rated depression (HDRS) were detected. MCT-Silver led to greater reductions in self-reported depression and rumination at post- and follow-up. Despite this, scores at post- and follow-up assessments were similar for both groups. MCT-Silver's effect on depressive symptoms was moderated by baseline rumination, positive metacognitive beliefs and previous treatment experience. MCT-Silver was evaluated as superior according to patient appraisals. Conclusions are limited by divergent findings on measures of depression and that the study was conducted during the COVID-19 pandemic. Whereas no superior effect of MCT-Silver was found for the primary outcome, there was a significant effect of MCT-Silver for self-reported depression and rumination. Patients endorsing rumination and positive metacognitive beliefs as well as those without previous psychological treatment may benefit more from MCT-Silver. • We evaluated the efficacy of metacognitive training for depression in later life (MCT-Silver). • 80 patients were randomized to MCT-Silver or a cognitive remediation (CR) group. • MCT-Silver demonstrated statistically significant effects beyond CR on self-reported depression and rumination. • Despite statistically significant effects, total scores at post- and follow-up were similar between groups. [ABSTRACT FROM AUTHOR]

• We developed meaning-centered psychotherapy for eating disorders (MCP-ED). • The efficacy of MCP-ED was tested in women with high weight and shape concerns. • After MCP-ED and at follow-up, participants reported higher levels of life meaning. • MCP-ED also resulted in lower levels of eating disorder symptoms. • Future studies should test the effectiveness of MCP-ED in a clinical sample. Low meaning in life has been proposed as an important factor in the maintenance of eating disorders and previous findings suggest that targeting meaning might optimize treatment effectiveness. The current randomized controlled trial aimed to investigate the efficacy of meaning-centered psychotherapy adjusted for eating disorders (MCP-ED) to improve meaning in women with high weight and shape concerns. Female students with high weight and shape concerns (N = 134) were randomly assigned to the waiting-list control condition or the experimental condition, in which they followed six weekly individual sessions of MCP-ED. Self-report measures of meaning, eating disorder symptoms, general distress, psychological well-being, and satisfaction with meaningful life domains were completed at baseline, after the final session of MCP-ED or a 7-week waiting period, and at 4-week follow-up. Participants in the experimental condition showed a stronger increase in meaning than participants in the waiting-list condition after the intervention and at follow-up. The intervention also resulted in lower eating disorder symptoms and general distress, and higher psychological well-being and satisfaction with meaningful life domains. Findings support the efficacy of MCP-ED as an intervention to increase meaning and point to the relevance of examining whether adding MCP-ED to regular treatment might increase treatment effectiveness in individuals with eating disorders. [ABSTRACT FROM AUTHOR]

Current management guidelines for the treatment of carotid stenosis are controversial. We performed this meta-analysis to evaluate the perioperative safety of carotid artery stenting (CAS) and endarterectomy. We systematically searched EMBASE, PubMed, Web of Science, and the Cochrane Library from inception to November 10, 2022, for randomized controlled trials that compared CAS with carotid endarterectomy (CEA) among patients with carotid stenosis. The analyzed outcomes mainly included stroke, death, myocardial infarction (MI), cranial nerve palsy, the cumulative incidence of mortality, stroke, or MI and the cumulative incidence of death or stroke in the perioperative periods. The risk ratio (RR) and 95% confidence interval (95% CI) were calculated and pooled. Subgroup analyses were based on whether patients were symptomatic or asymptomatic. We assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. Seventeen randomized controlled trials with 12,277 participants (6514 and 5763 in the CAS and CEA groups, respectively) were included. Pooled analysis demonstrated that compared with CEA, CAS was associated with decreased risks of perioperative MI (RR = 0.47, 95% CI = 0.29∼0.77) and perioperative cranial nerve palsy (RR = 0.02, 95% CI = 0.01∼0.06) but higher risks of perioperative stroke (RR = 1.48, 95% CI = 1.18∼1.87) and cumulative incidence of death or stroke (RR = 1.52, 95% CI = 1.20∼1.93). The perioperative safety was equivalent between CAS and CEA. However, CEA may be preferred when considering both procedural safety and long-term efficacy in preventing recurrent stroke. [ABSTRACT FROM AUTHOR]

Early adverse parenting predicts various negative outcomes, including psychopathology and altered development. Animal work suggests that adverse parenting might change amygdala–prefrontal cortex (PFC) circuitry, but work in humans remains correlational. The present study leveraged data from a randomized controlled trial examining the efficacy of an early parenting intervention targeting parental nurturance and sensitivity (Attachment and Biobehavioral Catch-up [ABC]) to test whether early parenting quality causally affects amygdala-PFC connectivity later in life. Participants (N = 60, mean age = 10.0 years) included 41 high-risk children whose parents were referred by Child Protective Services and randomly assigned to receive either ABC (n = 21) or a control intervention (n = 20) during the children's infancy and a comparison sample of low-risk children (n = 19). Amygdala-PFC connectivity was assessed via functional magnetic resonance imaging while children viewed fearful and neutral faces. Across facial expressions, ABC produced different changes than the control intervention in amygdala-PFC connectivity in response to faces. The ABC group also exhibited greater responses than the control intervention group to faces in areas classically associated with emotion regulation, including the orbitofrontal cortex and right insula. Mediation analysis suggested that the effect of ABC on PFC activation was mediated by the intervention's effect on amygdala-PFC connectivity. Results provide preliminary causal evidence for the effect of early parenting intervention on amygdala-PFC connectivity and on PFC responses to face viewing. Findings also highlight amygdala-PFC connectivity as a potential mediator of the effects of early parenting intervention on children's emotion regulation development. Intervening Early With Neglected Children; https://clinicaltrials.gov/ ; NCT02093052. We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. One or more of the authors of this paper received support from a program designed to increase minority representation in science. While citing references scientifically relevant for this work, we also actively worked to promote sex and gender balance in our reference list. [ABSTRACT FROM AUTHOR]

The excess neonatal adiposity is considered a risk factor for the development of childhood obesity and the birth weight is a marker of health throughout life. To evaluate the effect of a lifestyle intervention conducted among pregnant women with overweight on neonatal adiposity and birth weight. A total of 350 pregnant women were recruited and randomly allocated into the control (CG) and intervention (IG) groups. Pregnant women in the IG were invited to participate in three nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods, rather than ultra-processed foods, following the NOVA food classification system, which categorizes foods according to the extent and purpose of industrial processing, and the regular practice of physical activity. Neonatal adiposity was estimated using a previously validated anthropometric model. Adjusted linear regression models were used to measure the effect. Adopting the modified intention-to-treat principle, data from 256 neonates were analyzed for birth weight, and data from 163 for body composition estimation. The treatment had no effect on the proportion of fat mass [β 0.52 (95 % CI −1.03, 2.06); p =.51], fat-free mass [β −0.50 (95 % CI −2.45, 1.45); p =.61] or birth weight [β 53.23 (95 % CI −87.19, 193.64); p =.46]. In the present study, the lifestyle counselling used had no effect on neonatal adiposity or birth weight. Future studies should investigate the effect of more intensive interventions. • The intervention based on NOVA did not cause an undesirable effect on foetal development. • The nutritional intervention based on NOVA did not impair neonatal anthropometry. • Future research is needed to elucidate whether maternal lifestyle intervention can influence neonatal body composition. [ABSTRACT FROM AUTHOR]

This analysis of secondary outcomes investigated the applicability of supramaximal high-intensity interval training (HIT) with individually prescribed external intensity performed on stationary bicycles. Sixty-eight participants with a median (min; max) age of 69 (66; 79), at the time not engaged in regular exercise were randomized to 25 twice-weekly sessions of supramaximal HIT (20-min session with 10 × 6-s intervals) or moderate-intensity training (MIT, 40-min session with 3 × 8-min intervals). The primary aim was outcomes on applicability regarding; adherence to prescribed external interval intensity, participant reported positive and negative events, ratings of perceived exertion (RPE 6–20), and affective state (Feeling Scale, FS -5–5). A secondary aim was to investigate change in exercise-related self-efficacy (Exercise Self-Efficacy Scale) and motivation (Behavioural Regulations in Exercise Questionnaire-2). Total adherence to the prescribed external interval intensity was [median (min; max)] 89 % (56; 100 %) in supramaximal HIT, and 100 % (95; 100 %) in MIT. The supramaximal HIT group reported 60 % of the positive (112 of 186) and 36 % of the negative (52 of 146) events. At the end of the training period, the median (min; max) session RPE was 15 (12; 17) for supramaximal HIT and 14 (9; 15) for MIT. As for FS, the median last within-session rating was 3 (−1; 5) for supramaximal HIT and 3 (1; 5) for MIT. Exercise-related motivation increased (mean difference in Relative Autonomy Index score = 1.54, 95 % CI [0.69; 2.40]), while self-efficacy did not change (mean difference = 0.55, 95 % CI [-0.75; 1.82]), regardless of group. This study provide support for supramaximal HIT in supervised group settings for older adults. • Supramaximal HIT was well-tolerated by non-exercising older adults. • Supramaximal HIT participants reported more positive than negative events. • The findings provide support for the applicability of supramaximal HIT. [ABSTRACT FROM AUTHOR]

• Home-visiting interventions have positive effects on child cognitive development, parenting beliefs and parenting practices of caregivers in rural China. • Home-visiting interventions have null effects on child social-emotional development in rural China. • Three mechanisms are identified through which interventions are able to raise child cognitive development. • Shifting parenting beliefs; increasing parenting practices; and shifting parenting beliefs thus fostering better parenting practices of primary caregivers are the three mechanisms that are driving our overall results of the impact of home-visiting interventions on early child development. To better understand the impacts of parenting interventions (e.g., parental training of psychosocial stimulating activities) on child developmental outcomes and design effective policies to benefit young children, it is essential to identify the mechanisms through which the interventions work. To this end, this paper presents the results of two randomized controlled trials that offered home visitation, parenting trainings to 435 households (with 527 households as the control group) in 174 villages across three provinces in China. The findings from the randomized controlled trials showed that the interventions significantly improved child cognitive development and had a positive effect on the primary caregivers' parenting practices and their parenting beliefs. The analysis suggests three possible mechanisms through which the parenting interventions affected child cognitive development: changing the parenting beliefs of the primary caregivers, shifting the parenting practices of the primary caregivers, and improving the primary caregivers' parenting beliefs, thus fostering better parenting practices. [ABSTRACT FROM AUTHOR]

Despite their proliferation, limited knowledge exists regarding possible benefits of brief mindfulness ecological momentary interventions (MEMIs) for social anxiety disorder (SAD). Propositions that MEMIs could alleviate SAD symptoms and related clinical outcomes remain untested. This trial evaluated a 14-day MEMI for SAD. Participants with self-reported SAD were randomized to MEMI (n = 96) or self-monitoring app (SM; n = 95). Whereas MEMI instructed mindfulness exercises, SM prompted only self-monitoring five times daily for 14 days. Participants completed state-level self-reports of depression, anxiety, and mindfulness pre-post-mindfulness practice and SAD symptoms, worry, depression severity, repetitive negative thinking, and trait mindfulness at pre-randomization, post-intervention, and 1-month follow-up (1MFU). Hierarchical linear modeling was conducted. The MEMI yielded statistically significantly larger improvements in momentary depression, anxiety, and mindfulness (Cohen's d = −0.10–0.11). Although no between-group effects emerged in alleviating SAD fear and avoidance, excessive worry, depression severity, repetitive negative thinking, and trait mindfulness (−0.13–0.15), within-group effects were significantly small-to-large from pre-post and pre-1MFU (−4.62–0.67). A significant reduction in depression severity occurred in MEMI (−0.63–−0.60) but not SM (−0.31–−0.29). Brief MEMI and SM yielded nondifferent sustained effects on SAD, comorbid symptoms, and risk factors, highlighting its potential value within stepped-care delivery settings. • MEMI (vs. SM) notably improved state depression, anxiety, and mindfulness. • MEMI and SM enhanced SAD, worry, repetitive thinking, and trait mindfulness. • Depression severity was reduced in the MEMI but not the SM arm. • Brief MEMI might be efficacious for targeting pathological worry but not SAD. • MEMIs for SAD must be high-intensity and have exposure therapy to be efficacious. [ABSTRACT FROM AUTHOR]

Evaluate and compare the efficacy and safety of molnupiravir and favipiravir in outpatients with mild to moderate COVID-19 and at risk of severe COVID-19. In an open-label, parallel-group, multicenter trial in Thailand, participants with moderate COVID-19 and at least one factor associated with severe COVID-19 were randomly assigned 1:1 to receive oral molnupiravir or oral favipiravir (standard of care). Phone calls for remote symptom assessment were made on Days 6, 15, and 29. Participants with worsening symptoms were instructed to return to the hospital. The primary endpoint was pulmonary involvement by Day 29, as evidenced by ≥2 of the following: dyspnea, oxygen saturation <92% or imaging. Nine hundred seventy-seven participants (487 molnupiravir, 490 favipiravir) were enrolled from 8 July 2022 to 19 January 2023. 98% had received ≥1 dose of COVID-19 vaccine and 83% ≥3 doses. By Day 29, pulmonary involvement occurred in 0% (0/483) in molnupiravir arm versus 1% (5/482) in favipiravir arm (−1.0%; Newcombe 95.2% CI: −2.4% to −0.0%; P = 0.021); all-cause death in 0% (0/483) and <1% (1/482); COVID-19 related hospitalization in <1% (1/483) and 1% (3/482); treatment-related adverse event in 1% (5/483) and 1% (4/486); and serious adverse event in 1% (4/483) and 1% (4/486). Favipiravir and molnupiravir had a similar efficacy and safety profile. Whether either of the two reduced the risk of complications during the omicron era in this population with a low risk of pulmonary involvement and a high vaccine coverage remains unclear. There were no differences in any of the safety endpoints. TCTR20230111009. [ABSTRACT FROM AUTHOR]

Chinese herbal medicine is increasingly used as complementary therapy to manage nausea and vomiting in different cultures. One such herbal recipe is the Hezhong granules, which contain classical antiemetic formulations, and are commonly used to prevent chemotherapy-induced nausea and vomiting (CINV). Modern pharmacological studies have shown that the key components of Hezhong granules, including Pinellia ternata (Thunb.), Evodia rutaecarpa (Juss.), and Zingiber officinale exhibit significant antiemetic and antitumor properties. Despite this promising evidence, controlling CINV remains a significant challenge in cancer treatment. Moreover, there is a lack of scientifically designed clinical trials to validate the efficacy and safety of classical antiemetic formulas for CINV interventions. To investigate the efficacy and safety of Hezhong granules in preventing CINV in patients with advanced colorectal cancer (CRC). This study was conducted between October 2020 and February 2022 in 12 hospital wards in Southwest China. In this multicenter, randomized controlled trial, we enrolled patients with advanced CRC who received fluorouracil-based chemotherapy. The patients were randomly assigned in a 1:1 ratio to either the Hezhong granule group (receiving a 5-HT3-receptor antagonist, dexamethasone, and Hezhong granules) or the placebo group (receiving a 5-HT3-receptor antagonist, dexamethasone, and placebo) during the first and second courses of chemotherapy. A 5-day diary was provided to all patients. Acute and delayed CINV were defined as CINV occurring within 24 h or between 24 and 120 h after the start of treatment. The primary endpoints were complete response rate (CRR, defined as the proportion of patients without nausea/vomiting) and objective response rate (ORR, defined as the proportion of patients without nausea/vomiting plus mild nausea/vomiting) for both acute and delayed CINV. Secondary endpoints were the daily rates of CINV events and Functional Living Index-Emesis (FLIE). To identify the predictors of CINV, we conducted multivariate ordered logistic regression analysis. This study was registered with the Chinese Clinical Trial, number ChiCTR2100041643. A total of 120 participants were randomly assigned, of whom 112 (56/56) completed two cycles and were included in the full analysis. In the acute phase, there were minor improvements in the Hezhong granule group, but there were no significant differences in the CRRs for nausea and vomiting (mean difference:10.7 %, P = 0.318, 0.324), while the ORRs increased by approximately 17.5 % (mean difference:16.1 %, P = 0.051; 17.9 %, P = 0.037, respectively). In the delayed phase, significant improvements of approximately 20 % were observed in both the CRRs (mean difference:19.6 %, P = 0.053; 21.4 %, P = 0.035) and ORRs (mean difference:17.9 %, P = 0.037, 0.043) for nausea and vomiting. Additionally, the daily rate of CINV events showed a mean difference of 19 % (P < 0.05). According to FLIE scores, approximately 70 % of patients who received Hezhong granules reported an improvement in their quality of life, with CINV symptoms having"no impact on daily life (NIDL)". No serious adverse events were attributed to herbal medicine. Hezhong granules proved to be both effective and well-tolerated in preventing CINV in patients with advanced CRC, with notable benefits in preventing delayed CINV. These promising results set the stage for subsequent phase III clinical trials and experimental research on Hezhong Granules. [Display omitted] • Hezhong granule can increase the complete response rate of CINV by about 10 %–20 %. • Hezhong granule can increase the objective response rate of CINV by about 16 %–18 %. • Hezhong granule show better efficacy in preventing delayed CINV. • Hezhong granule is well tolerated and can significantly improve the quality of life of patients. [ABSTRACT FROM AUTHOR]

People engaged in treatment for opioid use disorder (OUD) report struggling with whether and how to disclose, or share information about their OUD history and/or treatment with others. Yet, disclosure can act as a gateway to re-establishing social connection and support during recovery. The current study describes a pilot randomized controlled trial of Disclosing Recovery: A Decision Aid and Toolkit, a patient decision aid designed to facilitate disclosure decisions and build disclosure skills. Participants (n = 50) were recruited from a community-based behavioral health organization in 2021–2022 and randomized to receive the Disclosing Recovery intervention versus an attention-control comparator. They responded to surveys immediately after receiving the intervention as well as one month following the intervention at a follow-up appointment. Primary outcome analyses examined indicators of implementation of the intervention to inform a future efficacy trial. Secondary outcome analyses explored impacts of the intervention on the decision-making process, disclosure rates, and relationships. Participants were successfully recruited, randomized, and retained, increasing confidence in the feasibility of future efficacy trials to test the Disclosing Recovery intervention. Moreover, participants in the Disclosing Recovery intervention agreed that the intervention is acceptable, feasible, and appropriate. They additionally reported a higher quality of their decision-making process and decisions than participants in the comparator condition. At their follow-up appointment, participants with illicit opioid use who received the Disclosing Recovery intervention were less likely to disclose than those who received the comparator condition. Moreover, significant interactions between illicit opioid use and the intervention condition indicated that participants without illicit opioid use who received the Disclosing Recovery intervention reported greater closeness to and social support from their planned disclosure recipient than those who received the comparator condition. The Disclosing Recovery intervention appears to be an acceptable, feasible, and appropriate patient decision aid for addressing disclosure processes among people in treatment for OUD. Moreover, preliminary results suggest that it shows promise in improving relationship closeness and social support in patients without illicit opioid use. More testing is merited to determine the intervention's efficacy and effectiveness in improving relationship and treatment outcomes for people in treatment for OUD. • People in opioid use disorder (OUD) treatment struggle with disclosure decisions. • Disclosing Recovery is a patient decision aid for disclosure decisions and skills. • It appears to be acceptable, appropriate, and feasible. • Future trials should examine its impacts on relationship and treatment outcomes. [ABSTRACT FROM AUTHOR]

Randomized controlled trials include interim monitoring guidelines to stop early for safety, efficacy, or futility. Futility monitoring facilitates re-allocation of limited resources. However, conventional methods for interim futility monitoring require a trial to accrue nearly half of the outcome data to make a reliable early stopping decision, limiting its benefit. As early stopping for futility will not inflate type-I error, these analyses are an appealing venue for incorporating external data to improve efficiency. We propose a Bayesian approach to futility monitoring leveraging real world data using Semi-Supervised MIXture Multi-source Exchangeability Models, which accounts for both measured and unmeasured differences between data sources. We implement futility monitoring using predictive probabilities and investigate the optimal timing with respect to the expected sample size under the null hypothesis. Because we only incorporate external data during the interim futility analysis the proposed design is not limited by type-I error inflation. When the external and trial data are exchangeable, the proposed method provides a roughly 70 person reduction in expected sample size under the null. Under scenarios where exchangeability does not hold, our approach still provides a 10–20 person reduction in expected sample size under the null with about 80% power. External data borrowing in interim futility monitoring is a promising venue to improve trial efficiency without type-I error inflation. Approaches that are acceptable to regulatory authorities and leverage the complementary strengths of real world and trial data are vital to more efficiently allocate limited resources amongst clinical trials. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the clinical efficacy and safety of administering intermittent theta burst stimulation (iTBS) to the medial prefrontal cortex for tobacco use disorder. A randomized sham-controlled trial was conducted, with 38 participants receiving 28 sessions of active (n=25) or sham (n=13) iTBS (2 sessions/day, 600 pulses/session, 110% resting motor threshold, AFz target) along with smoking cessation education (Forever Free © booklets) over 14 visits. Primary outcomes included self-reported cigarette consumption and abstinence, verified by urinary cotinine tests. Secondary outcomes included symptoms of tobacco use disorder, negative mood, and safety/tolerability. Both active and sham groups reported reduced cigarette consumption (β = −0.12, p = 0.015), cigarette craving (β = −0.16, p = 0.002), and tobacco withdrawal symptoms (β = −0.05, p < 0.001). However, there were no significant time x group interaction effects for any measure. Similarly, the two groups had no significant differences in urinary cotinine-verified abstinence. Adverse events occurred with similar frequency in both groups. There were no differences in cigarette consumption between the active and sham iTBS groups, both groups decreased cigarette consumption similarly. Further research is needed to compare iTBS to standard high-frequency rTMS and explore the potential differences in efficacy. Despite limitations, this study contributes to experimental design considerations for TMS as a novel intervention for tobacco and other substance use disorders, emphasizing the need for a more comprehensive understanding of the stimulation parameters and target sites. • Intermittent theta burst stimulation (iTBS) was tested for tobacco use disorder. • iTBS was administered on the medial prefrontal cortex for 14 visits. • Both active and sham iTBS reduced the number of cigarettes per day. [ABSTRACT FROM AUTHOR]

High prevalence and harmful consequences of hazardous drinking among medical-surgical patients underscore the importance of intervening with drinking to improve patients' health. This study evaluated a novel intervention, "Drinking Options - Motivate, Shared Decisions, Telemonitor" (DO-MoST). In a randomized design, 155 medical-surgical patients with untreated hazardous drinking were assigned to enhanced usual care or DO-MoST, and followed 3, 6, and 12 months later. We conducted intent-to-treat and per-protocol analyses. For the primary outcome, percent days of alcohol abstinence in the past 30 days, intent-to-treat analyses did not find superior effectiveness of DO-MoST. However, per-protocol analyses found abstinence increased between 3 and 12 months among participants assigned to DO-MoST who engaged with the intervention (n=46). Among DO-MoST-assigned participants who did not engage (n=27), abstinence stayed stable during follow-up. Group comparisons showed an advantage on abstinence for Engaged compared to Non-Engaged participants on change over time. Intent-to-treat analyses found that DO-MoST was superior to usual care on the secondary outcome of physical health at 12 months; per-protocol analyses found that Engaged DO-MoST-assignees had better physical health at 12 months than Non-Engaged DO-MoST-assignees. DO-MoST-assignees had lower odds of receiving substance use care during follow-up than usual care-assignees. Patients engaged in DO-MoST showed a greater degree of abstinence and better physical health relative to the non-engaged or usual care group. DO-MoST may be a source of alcohol help in itself rather than only a linkage intervention. Work is needed to increase DO-MoST engagement among medical-surgical patients with untreated hazardous drinking. • Untreated hazardous drinking harms medical-surgical patients and needs intervention. • RCT studied Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST). • Patients engaged in DO-MoST had better abstinence and physical health than others. • DO-MoST may be a source of alcohol help in itself, not only a linkage intervention. [ABSTRACT FROM AUTHOR]

• A randomized controlled trial to examine the effects of a nutrition education and a precise information (awareness-raising) intervention on dietary quality. • A significant and positive association between intervention and dietary quality is found. • The intervention effects are stronger for households with more than 25% and 50% of overweight people. Nutrition education interventions are widely used globally but with mixed results. We conducted a randomized controlled trial to examine the effects of a nutrition education and a precise message (awareness-raising) intervention on nutrition knowledge and dietary quality of households in rural China. Treatment groups first received a lecture on the Chinese Food Guide Pagoda, and then all family members were measured for height and weight and informed of household overweight status. We analyzed 358 households before and after this intervention. Participants in the treatment group increased their dietary knowledge by 6% and improved their dietary quality by 8% after the intervention. The intervention effects were stronger for households with more than 25% and 50% of overweight people. Our study provides evidence that an intervention based on general nutrition information and delivery of a precise message to households can effectively improve dietary quality. Our findings inform the food policy debate on whether nutrition information interventions are effective. Furthermore, to the best of our knowledge, this is the first study to evaluate the effectiveness of a nutrition information intervention to improve dietary quality in rural China. [ABSTRACT FROM AUTHOR]

• Upper-extremity musculoskeletal disorders are a prevalent public health issue. • A short spa therapy intervention did not improve function more than self-management. • Adherence to home exercise was greater for self-management than spa therapy. • Self-management interventions may reduce disability and pain. Musculoskeletal disorders (MSDs) are common in the workplace and are a public health issue. Persistent pain despite conservative treatment or surgery may lead to poor long-term outcomes. To compare the effect of a combined 6-day program of exercise, self-management workshops and spa therapy with self-management on functional capacity in personal and professional daily life at 3 months in people with musculoskeletal disorders. We conducted a prospective, randomized controlled trial. Participants were employed (any type of work) and aged between 18 and 65 years, with latent or symptomatic upper extremity MSDs, with or without a history of sick leave. They were randomized to participate in 6 days (2 h per day) of spa therapy, exercise, and self-management workshops immediately (intervention) or at 3 months (control). The control group performed self-management until 3 months. The primary outcome was the score on the self-reported Quick Disability of Arm-Shoulder-Hand (QuickDASH) at 3 months. The primary analysis was conducted using analysis of covariance with baseline QuickDASH score as the covariate. In total, 150 participants were randomized (85 % women): 78 to the control group and 72 to the intervention group. At 3 months, the QuickDASH total and work scores did not differ between groups (effect-size [ES] = -0.15, 95 %CI, -0.38 to 0.09, p = 0.215, and ES = -0.11, 95 % CI, -0.35 to 0.12, p = 0.343). However, QuickDASH sport/performing arts score was significantly different between randomization groups at 3 months (ES =-0.25, 95 % CI, -0.48 to -0.02, p = 0.035). This study provided no evidence in favor of a short-course, personalized self-management, intensive spa therapy intervention over self-management alone for the management of upper-extremity MSDs. Trial registration: ClinicalTrials.gov (NCT02702466) retrospectively registered. [ABSTRACT FROM AUTHOR]

A novel antibody–drug conjugate, trastuzumab deruxtecan is a combination of a human epidermal growth factor receptor 2 (HER2)-targeting antibody and DNA topoisomerase I inhibitor used to treat HER2-low/positive advanced breast cancer. To determine its safety and efficacy in treating HER2-low/positive advanced breast cancer, we performed a meta-analysis of several randomized clinical trials (RCTs) including DESTINY-Breast02 (NCT03523585), DESTINY-Breast03 (NCT03529110), and DESTINY-Breast04 (NCT03734029). We searched PubMed, Embase, and the Cochrane Library for RCTs on the efficacy and safety of trastuzumab deruxtecan that were published before May 2023. The efficacy endpoints included median progressive-free survival (PFS), overall survival (OS), duration of response (DOR), overall response rate (ORR), and clinical benefit rate (CBR). The safety endpoints included treatment-related adverse events. Statistical analyses were performed using RevMan 5.4 software. To ensure transparency, this study was registered on the International Prospective Register of Systematic Reviews website (CRD42023414170). Three RCTs involving 1689 patients were included. Compared with physician-recommended and conventional treatments, trastuzumab deruxtecan exhibited statistically significant improvements in PFS, ORR, and CBR. The median OS and DOR failed to be combined; however, the analyzed studies showed that they were longer. The incidence of adverse events was generally higher with trastuzumab deruxtecan than with physician-recommended or conventional treatments. The results of this study suggest that trastuzumab deruxtecan is more effective in treating HER2-low/positive advanced breast cancer than physician-recommended or conventional treatments. However, trastuzumab deruxtecan-related adverse drug reactions should be closely monitored because of its higher incidence of adverse events. • HER2-targeted therapy is ineffective in locally advanced or metastatic disease. • Trastuzumab deruxtecan may improve function compared to traditional treatments. • We included 1689 breast cancer patients from three randomized clinical studies. • Verification of trastuzumab deruxtecan's efficacy and safety is needed. [ABSTRACT FROM AUTHOR]

• A home-delivered non-pharmacological intervention contributed to reducing the immediate total and social loneliness of homebound older adults. • The decrease in perceived social loneliness mediated the improvement of depressive symptom levels. • Social loneliness may be a relevant target of intervention to improve depressive symptomatology. The present study aimed to explore whether the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered ten-week cognitive-emotional intervention, was effective in reducing self-reported loneliness among homebound older adults presenting mild cognitive impairment and psychological symptomatology. Effects of HEPPI in total, social, and emotional loneliness, compared with a treatment-as-usual group, were investigated at post-intervention and 3-month follow-up. In addition, the potential role of social and emotional loneliness as mediators of the HEPPI impact on episodic memory and symptoms of depression and anxiety was examined. This study built upon the data of a previously conducted randomized controlled trial. Participants were randomly assigned to the HEPPI group (n = 98) or the treatment-as-usual group (n = 101) and completed baseline, post-intervention, and 3-month follow-up assessments, including measures of loneliness (UCLA - Loneliness scale), episodic memory (Wechsler Memory Scale-III), depressive symptoms (Geriatric Depression Scale-30), and anxiety symptoms (Geriatric Anxiety Inventory). Data were analyzed on an intention-to-treat basis employing linear mixed models and mediation analyses for repeated measures. ClinicalTrials.gov identifier: NCT05499767. Compared with usual care controls, the HEPPI participants reported a significant immediate decrease in total and social loneliness, but these effects were not maintained at a 3-month follow-up. The reduction in immediate perceived social loneliness significantly mediated the improvement of depressive symptoms. The current findings suggest that HEPPI potentially reduced total and social loneliness of the homebound older population immediately post-intervention, and such decrease in social loneliness may be a relevant mechanism for improving their short-term depressive symptomatology. [ABSTRACT FROM AUTHOR]

To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF who undergo CR using this technology in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and HF related rehospitalization rates (secondary outcomes). A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients, according to guidelines, will perform 30-min of CR sessions with moderate intensity, twice a week for one month. Significant improvements in primary and secondary outcomes are expected in patients in the intervention group. If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes. [ABSTRACT FROM AUTHOR]

Although cognitive behavioral group therapy (CBGT) is an effective treatment for social anxiety disorder, many socially anxious patients are still symptomatic after treatment. A possible improvement for CBGT could come from the more experiential group psychotherapy, psychodrama (PD). The integration of CBGT and PD (labeled CBPT) might offer an even more effective treatment than CBGT or PD alone. With the present study, we investigated first whether three kinds of group therapy (CBGT, PD, and CBPT) are superior to a waitlist (WL). Second, we investigated whether CBPT is more effective than CBGT or PD alone. One hundred and forty-four social anxiety patients were randomly assigned to three active conditions or a WL. After wait, WL-participants were randomized over the active treatment conditions. The results of a multilevel analysis showed that all treatments were superior to WL in reducing social anxiety complaints. Only CBGT and CBPT differed significantly from WL in reducing fear of negative evaluations. There were no significant differences between active conditions in any of the variables after treatment and after six-month follow up, neither were there significant differences in treatment dropout. First there is the lack of a long-term follow-up. Second, because of loss of participants, we did not reach the planned numbers in the active treatment groups in comparison to WL. Moreover, this study was not designed as a non-inferiority or equivalence trial. Although the integrative CBPT showed good results, it was not more effective than the other treatments. • All treatments were superior to the waiting list group in reducing social anxiety. • Compared to WL, CBGT and CBPT but not PD decreased fear of negative evaluation. • Comparing only active treatments, no treatment was superior to another treatment. [ABSTRACT FROM AUTHOR]

Treatments for eating disorders are moderately effective, with cognitive behavior therapy (CBT) providing the strongest evidence. However, it remains important to investigate other interventions, particularly for eating disorders with greater complexity (e.g., substantial comorbidity; trauma history) or for patients who have not responded adequately to previous treatments. This randomized controlled trial compared CBT against compassion-focused therapy for eating disorders (CFT-E), where half of the sample had a childhood trauma history. The study was pre-registered and adequately powered. A total of 130 patients were randomly assigned to CBT or CFT-E and were assessed at pre-treatment, post-treatment and one-year follow-up. The primary outcome measure was the total score on the Eating Disorder Examination-Interview (EDE), and secondary outcome measures were the Symptom Checklist-90, Inventory of Interpersonal Problems–64 and Post-Traumatic Symptom Scale. Attrition during treatment was low (13%), suggesting good acceptability. Eating pathology (EDE scores) reduced substantially overall, with large effect sizes, and there were no differences between therapies. However, at follow-up, for patients with a childhood trauma history, CFT-E maintained benefits better than CBT. Conclusion : While both CBT and CFT-E resulted in significant reductions in eating pathology, CFT-E showed superior maintenance of benefits for patients with a history of childhood trauma at one-year follow-up, underlining the necessity of tailored interventions for specific patient subgroups. • Lack of treatment studies for eating disorder patients with trauma histories. • First study comparing CFT and CBT for eating disorders. • Both treatments viable; CFT superior in long-term outcomes for patients with trauma histories. [ABSTRACT FROM AUTHOR]

Need-based care is a structured and standardized model that supports formal caregivers in nursing homes in delivering person-centered care by responding with tailored non-pharmacological interventions on residents' unmet needs as well as having positive effects on behavioral and psychological symptoms on residents with dementia. However, limited resources as well as the shortage of caregivers in nursing homes make the implementation of need-based care challenging, especially when it comes to finding ways to spend more time with residents. The aim of this study is to evaluate the impact of the implementation of need-based care in nursing homes on formal caregivers' wellbeing. A three-arm cluster randomized controlled trial was set up in 24 Belgian nursing homes: formal caregivers in the 'need-based care' group (intervention; n = 195) spent time twice a week with residents who had behavioral and psychological symptoms according to the principles of need-based care while formal caregivers in the 'time' group (n = 257) filled in the way they spent time twice a week; a third group delivered standard care (n = 299). An implementation strategy was built upon the Implementation Quality Framework and used in the 'need-based care group'. A total of 741 formal caregivers completed the digital questionnaire at one or more of the five time points (every nine weeks) between November 2021 and July 2022; they rated their sense of competence in dementia care, level of burnout, and, level of engagement. Moments of time were registered in a printed registration book. Only formal caregivers from the 'need-based care' group experienced a higher sense of competence in dementia care at time points three (p = 0.010) and four (p = 0.001) compared with baseline with an increase of respectively 1.5 (95 % confidence interval [0.25, 2.84]) and 2.4 (95 % confidence interval [0.77, 4.04]) points. No differences in scores on burnout and engagement were found. Despite challenging workforce circumstances in nursing homes, caregivers in the need-based care group as well as in the time group were able to spend time twice a week with residents with behavioral and psychological symptoms. No negative effects were found on formal caregivers' wellbeing after the implementation of need-based care in nursing homes. However, it requires strong leadership and the use of well-considered implementation strategies including reflective practice. Trial registration number ISRCTN56768265 (10/08/2023). [ABSTRACT FROM AUTHOR]

Although swallowing exercises are a fundamental treatment for dysphagia, few studies have evaluated the effectiveness of swallowing training in patients with Alzheimer's disease. We recruited 93 patients with Alzheimer's disease from three hospitals in Guangdong, China. This was a parallel armed randomized controlled trial that randomly assigned patients to intervention (n = 48) and control (n = 45) groups. The intervention group adopted systematic stepwise swallowing training for four weeks based on routine dysphagia care. The control group implemented routine dysphagia care, including diet and posture management and health education about swallowing dysfunction. The swallowing function was the primary outcome, which was assessed using the Water Swallowing Test and Standard Swallowing Assessment. An abnormal eating behavior questionnaire was used to assess the incidence of aberrant eating behavior in patients with Alzheimer's disease. The Mini-Nutritional Assessment Short Form and Barthel index were adopted to evaluate the nutritional status and ability to carry out daily activities between groups. SPSS software was used to perform the chi-square test, t -test, and generalized estimation equation for data analysis. We analyzed the effects of the stepwise swallowing training program using the generalized estimating equation method. The intervention group exhibited greater improvements in their swallowing function (Water Swallowing Test: β = − 3.133, 95 % CI: − 4.113, − 2.154, P < 0.001; Standard Swallowing Assessment: β = − 5.813, 95 % CI: − 7.782, − 3.844, P < 0.001), abnormal eating behaviors (abnormal eating behavior questionnaire: β = − 13.324, 95 % CI: − 21.643, − 5.005, P = 0.002), daily function (Barthel index: β = 11.280, 95 % CI: 4.021, 18.540, P = 0.002), and nutritional status (Mini-Nutritional Assessment Short Form: β = 2.402, 95 % CI: 1.313, 3.490, P < 0.001) over time than the routine-care group in the fourth week. Stepwise swallowing training is a safe and effective intervention for managing dysphagia and other related symptoms in patients with Alzheimer's disease. [ABSTRACT FROM AUTHOR]

• Multi-domain cognitive improvements were found following low-intensity rTMS. • The majority of cognitive improvements sustained at 6 months. • Cognitive improvements were not correlated with psychotic improvement. Cognitive impairments are a core symptom of schizophrenia. Although low-intensity repetitive transcranial magnetic stimulation (rTMS) also has cognitive improving effect like the commonly used high-intensity rTMS, it has not been applied in schizophrenia yet. To fill this gap, inpatients with schizophrenia were randomized to receive 20 sessions of daily adjunctive active low-intensity rTMS in 4 weeks, or sham treatment. At baseline, 4 weeks, and 6 months, the Positive and Negative Syndrome Scale (PANSS) was used to assess psychotic symptom severity, while the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Stroop Color and Word Test (SCWT) were used to assess cognitive functions. Compared to the sixty-nine patients receiving sham treatment, those fifty-nine patients receiving active rTMS performed better in all cognitive domains at post-treatment with small to large effect sizes. This superiority of active rTMS over sham treatment remained significant at 6-month follow-up, with small to large effect sizes, except for visuospatial function and delayed memory. The reduction in PANSS scores were not correlated with cognitive improvements. Our findings provide evidence for using low-intensity rTMS to ameliorate cognitive impairments in schizophrenia. More research are needed to determine the optimal intensity for each domain of cognitive functions. [ABSTRACT FROM AUTHOR]

Mindfulness apps have become popular tools for addressing symptoms of depression and anxiety. Since the publication of earlier meta-analyses evaluating the efficacy of mindfulness apps for depression and anxiety symptoms, over 20 randomized controlled trials (RCTs) have been conducted. There is a need for an updated meta-analysis that quantifies the effects of mindfulness apps on these symptoms and tests for potential moderators.. Random effects meta-analyses were conducted on 45 RCTs. Small, significant effect sizes were found for symptoms of depression (N comp = 46, N = 5852, g = 0.24, 95% CI = 0.17, 0.31, NNT = 13.57) and anxiety (N comp = 48, N = 6082, g = 0.28, 95% CI = 0.21, 0.35, NNT = 11.47) in favour of mindfulness apps over control groups. This effect was not explained by symptom deterioration in participants allocated to control groups. Effects remained stable when restricting analyses to lower risk of bias and larger sample trials. No significant moderators were observed, except trials that offered monetary compensation produced larger effects on depression. Non-significant effects were observed when comparing mindfulness apps to active therapeutic comparisons (g = −0.15 depression, g = 0.10 anxiety), though the number of studies was low. Growing evidence indicates that mindfulness apps can acutely reduce symptoms of depression and anxiety, although higher quality studies with longer follow-ups are needed. • Conducted a meta-analysis of 45 trials of mindfulness apps on depression and anxiety. • Mindfulness apps led to small improvements in depression and anxiety relative to controls. • Mindfulness was not significantly different to active therapeutic comparisons. • Mindfulness apps may help improve symptoms of depression and anxiety to a modest degree. [ABSTRACT FROM AUTHOR]

To investigate the effects of a temporal self-regulation theory-based intervention on self-management in hemodialysis patients. A randomized controlled trial was carried out in Lanzhou, China. Participants were randomly allocated to either the intervention group (n = 42) or control group (n = 42). The outcomes of self-management level, interdialytic weight gain, serum potassium and serum phosphorus were collected at baseline (T0), 1 month after intervention (T1), and 2 months after follow-up (T2). After intervention and follow-up, the self-management score of the intervention group was significantly higher than that of the control group, while the interdialytic weight gain, serum potassium, and serum phosphorus were significantly lower. The group and time interaction effects revealed that participants in the intervention group exhibited significantly greater improvement in self-management at T1 and T2. Interdialytic weight gain decreased significantly at T2. Serum potassium levels did not differ significantly at T1 or T2. The changes in serum phosphorus were both significant at T1 and T2. This study demonstrated that the temporal self-regulation theory-based intervention was effective in improving hemodialysis patients' self-management. The findings suggest popularizing and applying this intervention in the clinic to maintain the long-term effectiveness of the intervention effect. • The temporal self-regulation theory is effective in the education of HD patients. • The intervention promotes HD patients' self-management. • The intervention can maintain the effects in a period of time. [ABSTRACT FROM AUTHOR]

• We assessed chatbot effects on problem gambling, with or without therapist support. • Gambling problems were improved regardless of the presence or absence of therapist support. • Therapist support showed no additional effect on gambling symptoms. • Examining the appropriate intensity and modality of therapist support is needed. Internet-based interventions can be a promising option for individuals with problem gambling facing barriers to seeking help. This study aimed to directly compare the effects of therapist-guided Internet interventions with unguided ones on gambling-related behavior, cognition, and stage of change including help-seeking intention. We conducted a participant-blinded randomized controlled trial of therapist-guided versus unguided groups with a 12-week follow-up. Both groups received self-help chatbot-delivered cognitive behavioral therapy. Additionally, at baseline and weeks 1, 2, 3, and 4, the guided group received personalized feedback messages from therapists based on their gambling diary and questionnaire responses. The unguided group received reminders of assessments from research assistants. The primary outcome was the change in scores on the Gambling Symptoms Assessment Scale (G-SAS) over 12 weeks. Secondary outcomes included the stage of change including help-seeking intention, money wagered, gambling frequency, and gambling-related cognitions. We included 139 participants with a mean Problem Gambling Severity Index total score of 14.6 and a mean G-SAS total score of 27.0 who sought information about gambling problems. Both groups demonstrated substantial decreases in their G-SAS scores from baseline to week 12 (-10.2, 95% CI: −7.67 to −12.7 for the guided group, and 11.7, 95% CI: −9.05 to −14.3 for the unguided group). However, we did not find a significant between-group difference (1.49, 95% CI: −2.20 to 5.17). Regarding the stage of change including help-seeking intention, there were also no between-group differences. Minimum therapist support did not have an additive effect on the self-help chatbot intervention on gambling symptoms, behavior, and the stage of change including help-seeking intention. [ABSTRACT FROM AUTHOR]

To compare the short, medium, and long-term effects of balance exercises combined with either peroneal neuromuscular electrical stimulation (NMES) or peroneal transcutaneous electrical nerve stimulation (TENS) on dynamic postural control and patient reported outcome measures (PROMs) in patients with chronic ankle instability (CAI). Thirty-four participants with CAI were randomly assigned to a 12-session home based exercise program combined with NMES (Ex-NMES) or TENS (Ex- TENS). Baseline postural control was tested with the modified Star Excursion Balance Test (mSEBT) and time to stabilization (TTS) after a single-leg drop-jump. The self-reported function was measured using the Cumberland Ankle Instability Tool (CAIT), the Identification of Functional Ankle Instability (IdFAI), and the Sports subscale of the Foot and Ankle Ability Measure (FAAM Sport). Both groups showed significant improvements in all self-reported outcome measures at the 12-month follow-up. Subjects in the Ex-NMES group had significantly better IdFAI (-4.2 [95% CI −8.1, −0.2]) and FAAM Sport (13.7 [95% CI 2.2, 25.2]) scores at 6- and 12-month follow-up, respectively, compared to the Ex-TENS group. Medium to large between-group effect sizes were observed in self-reported functional outcomes and the mSEBT. The consistent trend of improvement in self-reported functional outcomes when training is combined with NMES compared with training with TENS may indicate a potential benefit that should be further investigated as a treatment for patients with CAI. [ABSTRACT FROM AUTHOR]

Online treatment delivery has the potential to increase access to evidence-based mental health care for children with anxiety disorders. Using a randomized controlled trial design, we evaluated the efficacy of Cool Kids Online, a family-based and therapist supported internet-delivered cognitive behavioral treatment (CBT) designed to target anxiety disorders in children. Ninety-five children aged 7–12 years with a DSM-5 anxiety disorder were randomly allocated to Cool Kids Online or a waitlist control. Children were assessed at baseline, week 11, and 6-months following treatment. Children in waitlist received treatment after week 11 and also completed assessments immediately and six months after treatment, allowing treatment maintenance to be evaluated for all children. Compared to waitlist, Cool Kids Online led to significantly greater remission of anxiety disorders (primary and all anxiety diagnoses) and greater reduction of caregiver-reported anxiety symptoms and interference at week 11. Child-reported anxiety symptoms and interference and child- and caregiver-reported depressive or externalizing symptoms did not differ significantly between conditions. Medium to large within-treatment effects were observed for all children from pre to post treatment with post treatment effects maintained until follow-up. Overall, the findings provide support for the efficacy of the program in treating anxiety. Cool Kids Online compared to waitlist for the remission of anxiety disorders in clinically anxious children; anzctr.org.au ; ACTRN12615000947505. • Online family-based cognitive behaviour therapy reduces child anxiety disorders. • Therapist support during online child anxiety programs may be important for change. • Cool Kids Online is a promising method to improve access to child anxiety treatment. [ABSTRACT FROM AUTHOR]

Parenting of preterm infants presents unique challenges, particularly during their transition from hospital to home. Early discharge programs can assist parents during this critical period. However, the feasibility of delivering a family-focused online discharge program remains understudied. This study was conducted to investigate the impact of a family-focused online parenting support intervention on parents' sense of competence, depression, caregiving, social support, family functioning, and the weight and length of preterm infants. We conducted a single-blind, two-arm randomized controlled trial with a repeated-measures design. Participants were recruited from a specialized tertiary hospital in China between May and December 2022. Forty-five families were randomly assigned to the intervention group and 44 to the control group. The intervention included three components: (1) two one-hour group sessions and three 30-minute individual sessions of online parenting support; (2) two follow-up telephone calls (15–30 min each) post-discharge; and (3) access to online parenting resources. Primary outcomes included parenting sense of competence, parental care ability, and preterm infants' weight and length. Secondary outcomes included depression, social support, and family functioning. Measurements were taken at baseline, preterm infant discharge, one month post-discharge, and three months post-discharge. A generalized estimating equation model was employed based on the intention-to-treat principle for outcome comparison. Parents in the intervention group showed significant improvements in parenting sense of competence (P < 0.001), parental care ability (P < 0.001), depression (P < 0.001), and social support (P = 0.002). However, no statistically significant differences were observed in preterm infants' weight and length, or in family functioning (P > 0.05). Although the intervention did not affect preterm infants' outcomes, the positive enhancements in parenting sense of competence, care ability, depression, and social support indicate that online family-focused parenting support can effectively prepare parents for hospital discharge and the early transition period. [ABSTRACT FROM AUTHOR]

Pair-matching in randomized controlled trials (RCTs) has received increased attention in criminology, the social sciences more generally, and medicine and public health, with a growing body of research demonstrating the design's benefits over "simple" RCTs. We carry out a review of matched-pair RCTs compared with simple RCTs to address a somewhat provocative yet fair question for evaluation research on crime and violence prevention interventions: Is it time for the use of pair-matching in all RCTs? At the heart of this question is the ability of the design to most efficiently and robustly compare like with like, thereby, improving confidence in observed effects of intervention trials. Several key findings emerge from the review. First, it is inadequate to examine or discuss RCTs as a single, uniform evaluation design. Here, the key organizing construct is the unit of allocation: individuals; groups of individuals (or clusters); and geographical places. Second, the advantages vastly outweigh the disadvantages for the use of matched-pair RCTs compared to simple RCTs, and most of the advantages hold for all three units of allocation. Third, pair-matching can be used with rather small samples (≥6 units) in cluster-based trials without compromising statistical power or degrees of freedom; less is known about individual- and place-based trials. Fourth, pair-matching cannot be used with some types of RCTs (e.g., cross-over) and is less amenable in other contexts (e.g., RCTs that enroll and randomize individuals on a rolling basis). Implications for evaluation research and public policy are discussed. • Pair-matching in RCTs has received increased attention in criminology and medicine. • Key organizing construct is unit of allocation: individuals; clusters; or geographical places. • Advantages vastly outweigh disadvantages for the use of matched-pair RCTs compared to simple RCTs. • Pair-matching can be used with small samples in cluster-based trials without compromising power. [ABSTRACT FROM AUTHOR]

Sleep disturbance is commonly reported among individuals meeting criteria for cannabis use disorder (CUD), and people who use cannabis frequently report sleep disturbance as a contributor to failed quit attempts. The purpose of this study was to measure sleep in individuals enrolled in treatment for CUD, and to determine whether use of hypnotic medication during treatment increased abstinence rates. The study enrolled 127 adults seeking treatment for CUD in a 12-week clinical trial and randomized to receive extended-release zolpidem (zolpidem-XR) or placebo. All participants received computerized behavioral therapy and abstinence-based contingency management. The study conducted in-home ambulatory polysomnography (PSG) assessments at baseline and during treatment to objectively measure sleep. Self-report measures of recent sleep, Insomnia Severity Index (ISI), and drug use (Timeline Follow-Back) were collected at each study visit, and the study confirmed self-reported abstinence via quantitative urine drug testing. Participants randomized to placebo, but not zolpidem-XR exhibited significant sleep disturbance during week 1 of treatment. Sleep disturbance emerged in the zolpidem-XR group after study medication was stopped at the end of treatment. Though participants assigned to the zolpidem-XR condition had qualitatively greater rates of abstinence compared with placebo (27 % versus 15 % negative at end of treatment), the difference was not statistically significant. Treatment retention was poor (about 50 % drop out in both groups) and medication adherence was a challenge without the use of contingent incentives. Results from this randomized controlled trial suggest that zolpidem-XR can attenuate abstinence-induced sleep disturbance early in treatment for CUD, but that sleep problems are likely to emerge after the medication is stopped. Further research should identify alternative pharmacotherapies and behavioral treatments for CUD and elucidate the role of sleep disturbance in the development and maintenance of CUD. • Sleep disturbance is commonly reported among individuals with cannabis use disorder. • This RCT evaluated extended-release zolpidem for cannabis-related sleep disturbance. • Zolpidem-XR attenuated sleep disturbance but sleep problems re-emerged at EoT. • Zolpidem-XR resulted in non-significant improvement in cannabis abstinence relative to placebo. [ABSTRACT FROM AUTHOR]

To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. ClinicalTrials.gov identifier NCT05006872 ; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care. [ABSTRACT FROM AUTHOR]