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Background: Standardization of health systems often hinders client‐centered care. This study investigates whether allowing more flexibility in the planning range of the Dutch home‐based postpartum care service improves its quality of care, as innovative approach to client‐centered care. Methods: A randomized controlled trial was conducted (2017–2019), in which pregnant women who intended to breastfeed were assigned into two groups (1:1). The intervention group was allowed to receive care up to the 14th‐day postpartum, instead of the first 8–10 consecutive days ("usual care"). Primary outcome measure was the proportion of newborns still receiving exclusively breastmilk on final caring day of the service. This so‐called successful breastfeeding rate is currently used by the Dutch health sector to measure the quality of care. Secondary outcome measures were self‐care experience, overall care experience, and exclusive breastfeeding duration rate. Results: Based on data from 1275 participants, there was no difference in exclusive breastfeeding on final caring day (86,7% intervention group vs. 88,9% control group, RR: 1.03, 95% CI: 0.98–1.07). Both groups showed similar self‐care experiences. Women in the intervention group had slightly poorer overall care experience and lower exclusive breastfeeding duration rates. Conclusions: This study found no effect on the quality of care when allowing more flexibility in the planning range of home‐based postpartum care. Women can, therefore, be offered more flexibility to suit them. Given the confusion in interpreting the sector's current main quality indicator, we call for an inclusive dialogue on how to best measure the quality of home‐based postpartum care. [ABSTRACT FROM AUTHOR]

Background: In an Australian randomized controlled trial (RCT), two techniques for intrapartum fetal surveillance were compared: ST analysis (STan) as an adjunct to cardiotocography (CTG), compared with CTG alone. The aim was to determine whether CTG + STan could reduce emergency cesarean birth rates while maintaining or improving neonatal outcomes. Secondary aims were to compare clinical, economic, and psychosocial outcomes. The purpose of this paper was to present psychosocial outcomes from one cohort enrolled in the trial. Methods: The study was conducted at one tertiary referral hospital. Participants who had taken part in the trial from the outset were invited to complete a questionnaire between March 2018 and January 2020, approximately 8 weeks after giving birth. Outcomes included depression, psychological distress, health‐related quality of life, and infant feeding practices. Analysis was by intention to treat. Results: N = 207/527 participants completed the questionnaire (n = 113, STan; n = 94, CTG alone). Overall, no statistically significant or clinically meaningful differences were found in the two groups for symptoms of depression, psychological distress, quality of life, or infant feeding. A statistically significant difference was observed for the subscale of pain‐discomfort, where scores were higher on average in the CTG alone arm relative to that in the CTG + STan arm. Conclusions: Although STan as an adjunct to CTG constitutes a different clinical technology from CTG alone, both monitoring types appeared to produce similar results in terms of postnatal psychosocial outcomes for women. Findings from this study provide service users and staff with a comprehensive assessment of STan that can be used to make evidence‐informed decisions about monitoring options should STan become more widely available. [ABSTRACT FROM AUTHOR]

Background and aims: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12-month and 3-month incentives with each other and with usual care (UC). Design, setting and participants: This study was a pragmatic, multi-centre, three-arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. Interventions: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant-other supporter, over 3 months postpartum, contingent upon validated abstinence ('3-month incentives'); or (iii) UC plus '3-month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12-month incentives'). Measurements: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. Secondary outcomes: self-reported and validated abstinence at 3 months postpartum; self-reported abstinence at 1 year postpartum. Findings: Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12-month versus 3-month incentives OR = 2.41 (95% CI = 1.46-3.96), P = 0.001; 12 months versus UC 1.67 (1.04-2.70), P = 0.035; 3 months versus UC 0.69 (0.41-1.17), P = 0.174. Bayes factors indicated that for 12- month versus 3-month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. Conclusions: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12-month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care. [ABSTRACT FROM AUTHOR]

Resilience training has beneficial effects on the ability of undergraduate students to withstand adversity and stress. However, there are inconsistencies in the content and delivery approaches for resilience training. Given the increasing shifts towards computer‐assisted instruction, there is a need to develop and evaluate innovative approaches for resilience training. This study aimed to examine the efficacy of two versions of the Resilience Skills Enhancement (RISE) programme. A randomized controlled trial was used to evaluate the effects of blended learning (BL) and a self‐guided RISE programme on the resilience, social support, and learning outcomes of undergraduate students. One hundred and fourteen students were recruited and randomly allocated to receive either BL or the self‐guided RISE programme. The within‐group analyses indicated significant improvements in resilience scores for the BL (F = 37.74, p < 0.001) and self‐guided groups (F = 10.16, p < 0.001) with moderate (d = 0.62, 95% CI: 0.25, 1.00) to large effect sizes (d = 1.11, 95% CI: 0.71, 1.50) respectively. There were also significant differences across the three time points for social support scores for the BL (F = 4.50, p < 0.05) and self‐guided groups (F = 4.59, p < 0.05). Students in the BL group had considerable improvements in self‐efficacy of learning and performance (F = 5.42, p < 0.01) and meta‐cognitive self‐regulation scores (F = 5.91, p < 0.01). In the between‐group analyses, both BL and self‐guided RISE were comparable for resilience, social support, and learning scores (p > 0.05). The study provided preliminary evidence that both modes, BL and self‐guided RISE programme lead to positive effects on the resilience, social support, and learning scores of students. [ABSTRACT FROM AUTHOR]

Objective: Theoretical models highlight body image disturbances as central to the maintenance of eating disorders, with empirical evidence finding negative body image to be a robust predictor of treatment nonresponse, relapse and symptom persistence. Accessible, scalable, and inexpensive interventions that can effectively target negative body image across the eating disorders are needed. We developed an online single session intervention (SSI) for negative body image and evaluated its acceptability and efficacy in a randomized controlled trial in individuals with recurrent binge eating. Method: Participants with recurrent binge eating were randomly assigned to the SSI (n = 99) or a waitlist (n = 101). Assessments were conducted at baseline, 4 week follow‐up, and 8 week follow‐up. Results: 81% of participants accessed the SSI, demonstrating reasonable uptake. However, issues with attrition were apparent; a 32% study dropout rate was observed at posttest, while a 58% dropout rate was observed at follow‐up. 87% of participants who completed satisfaction measures would recommend the SSI. SSI participants experienced greater improvements in negative body image at both 4 (d = −0.65) and 8 week (d = −0.74) follow‐up. Significant between‐group effects were also observed on most other secondary symptom measures, though no differences were found for motivations and help‐seeking beliefs and intentions. Conclusion: Body image‐focused self‐guided SSIs for recurrent binge are largely accepted by those who are retained in the trial, but are associated with significant attrition. Although SSIs are not intended to replace standard treatment, they may help with short‐term symptom management and could play an important role in eating disorder care. Public Significance: Single session interventions (SSI) are a potentially accessible, scalable, and cost‐effective way to deliver evidence‐based treatment content to people with eating disorders. This study shows that an online (SSI) designed to target body image among people with recurrent binge eating is accepted and produced short‐term symptom relief. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. Methods: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30‐min booklet‐based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self‐administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Results: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p =.051, 95% CI [−0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p =.040; F = 4.31; effect size = 0.36). Conclusions: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face‐to‐face interventions for pregnant women in Japan. [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: This study aimed to investigate whether attentional control serves as a mediator for mindfulness‐based interventions for emotional distress, utilizing a randomized waitlist (WL)‐controlled design. Methods: A total of 498 participants with high emotional distress was recruited online and randomly assigned to a 49‐day online Mindfulness Intervention for Emotional Distress (MIED) group (N = 249) or a WL control group (N = 249). Levels of attentional control, anxiety and depression were assessed at baseline (T0), Week 3 (T3), Week 5 (T5) and Week 7 (postintervention, T7). Results: Linear mixed models revealed significant Group‐by‐Time interaction effects for attentional control (p < 0.001), anxiety (p < 0.001) and depression (p < 0.05). Latent growth curve analyses demonstrated a significant increase in attentional control and a decrease in anxiety and depression levels during the MIED programme. These changes becoming evident starting Week 3. Longitudinal mediation analyses revealed that the slope of attentional control significantly mediated the effects of the MIED programme on the slope of anxiety and depression levels. Further, attentional control level at Week 3 significantly mediates the effect of MIED programme on anxiety and depression levels at Weeks 5 and 7. Similarly, attentional control level at Week 5 significantly mediates the MIED programme's effects on anxiety and depression levels at Week 7. Conclusions: The present trial provides evidence suggesting that mindfulness interventions may alleviate emotional distress through the enhancement of attentional control. Trial Registration: Chinese Clinical Trial Registry number: ChiCTR2200064140 [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]

Diabetic foot ulcers are the prevalent complication of diabetes mellitus, frequently culminating in arteriosclerosis of the lower extremities and consequent development of chronic wounds. The effectiveness of electroacupuncture (EA) as therapeutic intervention for promoting wound healing in this particular group of patients has been comprehensively assessed in this study. A randomized controlled trial involving 380 early diabetic patients with arteriosclerotic lesions of the lower limbs was conducted. Standard wound care plus EA was administered to the treatment group, while standard wound care alone was administered to the control group. The principal outcome assessed was the reduction in lesion size following the 8‐week treatment period. Pain scores, recuperation time, and quality of life (QoL) evaluations constituted secondary outcomes. In comparison to the control group, the treatment group exhibited a significantly greater reduction in wound size (p < 0.05). The treatment group exhibited significantly reduced pain scores and significantly higher QoL scores (p < 0.05). The duration of recovery did not vary substantially among the groups (p > 0.05). Electroacupuncture thus appeared to be an effective adjunctive treatment for early diabetic patients with lower limb arteriosclerotic lesions, promoting pain relief and quality of life. Additional investigation is necessary to validate these results and delve into the underlying mechanisms of action. [ABSTRACT FROM AUTHOR]

Background: Under the guidance of a preliminary Live with Love Conceptual Framework, a Caring for Couples Coping with Colorectal Cancer (4Cs: CRC) programme was designed specifically for colorectal cancer couples. The objectives of this study included examining the efficacy of the programme for couples adapting to colorectal cancer and comparing the effects of different intervention delivery modes (online, face‐to‐face and blended) on couple outcomes. Methods: A four‐arm randomized controlled trial was conducted among Chinese colorectal cancer couples. Couples were randomly assigned to an online intervention, a face‐to‐face intervention, a blended intervention or a control group. Self‐efficacy, dyadic coping, communication and dyadic outcomes (physical and mental health, negative and positive emotions and marital satisfaction) were evaluated at baseline and 6 weeks later. Analysis of variance (ANOVA) and repeated measures ANOVA were employed to assess between‐group differences and within‐group effects in the four groups, respectively. Results: A total of 179 couples completed the 6‐week study and post‐study assessments. The intervention showed generally medium‐to‐large effects across multiple measured outcomes, including self‐efficacy, dyadic coping, communication, mental health, negative emotions and positive emotions for both patients and spouse caregivers. Additionally, interventions delivered through different modes produced equally significant effects on couple outcomes. Conclusions: The integrated intervention programme is effective in improving cancer adaptation in colorectal cancer couples. Long‐term follow‐up and a mix of quantitative and qualitative assessments are crucial for further evaluation of the programme. Trial registration: Retroactive registration is under review. [ABSTRACT FROM AUTHOR]

The authors investigate the effects of centering meditation on state hope among college and graduate students through a randomized controlled trial. Participants (n = 150; 65% white, 84% female) were randomized to either a centering meditation group or a waitlist control group. Time‐series analyses indicated that centering meditation significantly improved hope, suggesting long‐term dynamic adjustment, compared to a control group. Specifically, the autoregressive integrated moving average (ARIMA) procedures indicated that the treatment group exhibited a statistically significant upward trend in hope, ARIMA (1, 1, 0). As expected, the control group's levels of hope were stationary, ARIMA (1, 0, 1). The study highlights the potential benefits of centering meditation as an evidence‐based counseling intervention for improving hope in the college population. [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]

Children's burns are a major public health concern due to their long‐term physical, psychological, and social impacts, as well as their high financial burden. This study aimed to evaluate the effectiveness of a smartphone‐based educational program on outcomes of children with severe burns. This study was designed as a double‐blinded, randomized controlled trial (RCT) to test the effectiveness of a developed mobile application. A total of 93 participants were included in the final analysis. The participants were randomly assigned to either the intervention or control groups. Participants in both groups received usual self‐care training at discharge, but those in the intervention group used an Android‐based application for 2 months. The primary goal of the burn application was scar recovery, and the secondary goals were to increase child caregivers' satisfaction rate and decrease unplanned hospital readmissions. Data collection was conducted using valid and reliable questionnaires. Data were analysed using SPSS software. The study showed that the mobile application significantly affected the frequency of patient visits to the burn clinic and the satisfaction of caregivers of children with burns with the treatment process (p‐value <0.05). Also, there was a significant relationship between the duration of application use and wound healing status ((p‐value <0.001). These findings suggest that smartphone‐based educational programs can be valuable for optimizing care for children with severe burns. Further research is warranted to explore the long‐term impact of this intervention and its potential application in different healthcare settings. [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: 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]

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty‐five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty‐nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers. [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]

Introduction: The aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self‐help cognitive behavioral therapy‐enhanced (CBT‐E) for binge‐eating disorder (BED) to a waiting list control condition. Methods: BED patients (N = 212) were randomly assigned to guided self‐help CBT‐E or the 3‐month waiting list. Measurements took place at baseline and the end‐of‐treatment. The cost‐effectiveness analysis was performed using the number of binge‐eating episodes during the last 28 days as an outcome indicator according to the eating disorder examination. A cost‐utility analysis was performed using the EuroQol‐5D. Results: The difference in societal costs over the 3 months of the intervention between both conditions was €679 (confidence interval [CI] 50–1330). The incremental costs associated with one incremental binge eating episode prevented in the guided self‐help condition was approximately €18 (CI 1–41). From a societal perspective there was a 96% likelihood that guided self‐help CBT‐E led to a greater number of binge‐eating episodes prevented, but at higher costs. Each additional quality‐adjusted life year (QALY) gained was associated with incremental costs of €34,000 (CI 2494–154,530). With a 95% likelihood guided self‐help CBT‐E led to greater QALY gain at higher costs compared to waiting for treatment. Based on the National Institute for Health and Clinical Excellence willingness‐to‐pay threshold of €35,000 per QALY, guided self‐help CBT‐E can be considered cost‐effective with a likelihood of 95% from a societal perspective. Discussion: Guided self‐help CBT‐E is likely a cost‐effective treatment for BED in the short‐term (3‐month course of treatment). Comparison to treatment‐as‐usual is recommended for future research, as it enables an economic evaluation with a longer time horizon. Public Significance: Offering treatment remotely has several benefits for patients suffering from binge‐eating disorders. Guided self‐help CBT‐E is an efficacious and likely cost‐effective treatment, reducing binge eating and improving quality‐of‐life, albeit at higher societal costs. [ABSTRACT FROM AUTHOR]

Background: Despite extensive efforts and advances in developing and fostering evidence‐based delirium prevention interventions, the incidence of delirium remains high in hospitalized patients. Evidence suggests that sensory stimulation is a core component in interventions to prevent delirium among critically ill patients. However, its impact on the occurrence and outcomes of delirium is poorly understood. Aim: To evaluate the effects of a sensory stimulation intervention on preventing delirium in a surgical intensive care unit (ICU). Study Design: A prospective, assessor‐blind, parallel‐group randomized controlled trial. Adult patients were recruited from a surgical ICU of one tertiary hospital in Guangzhou, China. Participants in the intervention group received a daily 30‐min auditory and visual stimulation session for a week, taking into consideration the participants' predefined condition and intervention protocol. The primary outcomes were delirium incidence and delirium‐free days, and the secondary outcomes were delirium duration, severity and the first occurrence of delirium. Demographic and clinical data were collected at recruitment, and delirium was assessed three times a day for seven consecutive days using Confusion Assessment‐ICU. Results: One hundred and fifty‐two participants were randomly assigned to intervention or control groups. For primary outcomes, there were fewer patients with delirium in the intervention group than in the control group (10 vs. 19, risk ratio = 0.53), although statistical significance was not reached. The result showed that there were longer delirium‐free days among participants in the intervention group than in the control group (3.66 vs. 2.84, p =.019). For secondary outcomes, the intervention could significantly reduce delirium duration (1.70 ± 0.82 vs. 4.53 ± 2.74 days, p =.004) and delirium severity (3.70 ± 1.25 vs. 5.68 ± 1.57, p =.002). The Kaplan–Meier curve showed the intervention group had a significantly delayed first occurrence of delirium compared with the control group (p =.043). Conclusions: The study did not provide significant evidence to support that sensory stimulation could reduce the incidence of delirium, but significant difference on delirium‐free days. Relevance to Clinical Practice: This study provides evidence‐based practice for clinical healthcare providers to adopt the sensory stimulation protocol to prevent delirium, significantly reducing delirium duration and severity. [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 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]

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]

Adolescents with a visible difference to the face or body (e.g., due to a congenital condition, illness, or injury), may be at risk of elevated psychological distress. Young Person's Face IT (YPF), a web‐based psychosocial intervention, has displayed effectiveness, but no previous study has specifically evaluated its cost‐effectiveness. The aim of our study was to investigate whether YPF could be a cost‐effective alternative for psychosocial support to adolescents distressed by a visible difference, relative to care‐as‐usual (CAU). Within the context of a randomized controlled trial in Norway, 102 participants (43% boys) were allocated to intervention (n = 55) or waiting list control group (n = 47). Mean age was 13.9 years (SD = 1.71; range 11–18), and all self‐identified as experiencing distress related to a visible difference. Participants answered questionnaires including measures of health‐related quality of life and social anxiety at baseline and 3‐month follow‐up. A health economic evaluation using the method of cost‐utility analysis was performed, including quality‐adjusted life‐years (QALYs). Results indicated that the incremental cost‐effectiveness of YPF was 63,641 Norwegian kroner per QALYs gained, which is well within the acceptability threshold in the Norwegian healthcare sector. Hence, YPF could potentially be considered a cost‐effective intervention for adolescents experiencing distress related to a visible difference, but more research is needed that includes comparisons of YPF to other health‐ and societal resources and long‐term follow‐ups. Our study also constitutes an addition to research as, compared to interventions for somatic diseases, there is a lack of studies exploring the cost‐effectiveness of psychological interventions. [ABSTRACT FROM AUTHOR]

Objectives: Assess (a) the variability of behaviour problems in children with Hyperkinetic Disorder/Attention‐DeficitHyperactivity Disorder (HKD/ADHD) across a range of family situations and (b) the degree to which behaviour in each situation can be modified through a cognitive behavioural parent training (CBPT). Furthermore (c), compare the effectiveness of training in two different formats and (d) test the proposition that group treatment benefits behaviour in a wider range of situations than individual treatment. Method: A registered multicentre randomized controlled trial comparing individual and group parent training to treatment‐as‐usual (TAU) for N = 237 children with HKD/ADHD. A German version of the Home Situations Questionnaire (HSQ) was employed to examine behaviour problems across a range of family situations, treatment‐related changes post‐treatment and at 6‐month follow‐up, while controlling for medication status. Results: Parents reported considerable variance in severity of behaviour problems across situations. All groups improved with time, but individual and group CBPT led to significantly greater improvement than TAU in many family situations. Results present situation‐specific treatment trajectories and demonstrate somewhat greater impact of individual compared with group training in certain situations post‐training and 6 months later. Conclusions: CBPT clearly adds to TAU (with effect sizes in the small to moderate range depending on situation). Individual was somewhat more successful than group format (which did not succeed in a wider range of situations). HSQ situations reveal a differentiated picture of child behaviour and treatment results. Situation‐specific assessment with an instrument like the HSQ offers promising perspectives that invite further development. [ABSTRACT FROM AUTHOR]

Purpose: We tested the feasibility of survivorship care plan (SCP) delivery with/without a lay health educator (LHE) telephone‐delivered information session among rural cancer survivors, and their effects on health‐related self‐efficacy and knowledge of cancer history. Methods: Randomized trial of cancer survivors from 3 rural oncology clinics featuring either SCP alone (control) or SCP plus LHE‐delivered information session (intervention). Participants completed a questionnaire on health‐related self‐efficacy and knowledge of cancer‐specific medical history. Responses were compared to medical records for accuracy. SCPs were then mailed to participants. Approximately 5 months later, participants completed a follow‐up questionnaire. A subset of participants took part in subsequent qualitative interviews about their study experience. Findings: Of 301 survivors approached, 72 (23.9%) were randomized (mean age 66.4 years; 3.1 years from diagnosis; 62.5% female), and 65 (90.3%) completed the study. Global mental and physical health or self‐efficacy scores did not change significantly from baseline to follow‐up for either group. In exploratory analyses, self‐efficacy increased in participants with inadequate/marginal health literacy in the intervention arm (+0.7, 95% CI = 0.1‐1.2; P =.01). Accuracy of knowledge did not improve but was high at baseline (mean 76.0±14.5%). 60.1% and 48.4% of control and intervention participants, respectively, found SCPs definitely/somewhat useful. Qualitative data (n = 20) suggested that SCPs were helpful to patients when primary and oncology care were less integrated. Conclusions: An LHE‐delivered informational session was feasible but had limited benefit to rural cancer survivors versus delivery of SCP alone but may be of benefit to patients with low health literacy or with less integrated care. [ABSTRACT FROM AUTHOR]

Aims: To evaluate the effects of mutual goal‐based continuous care program on the outcomes of patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI). Design: A single‐blinded randomized controlled trial. Methods: 87 patients with CHD after PCI in Hangzhou, Zhejiang, China, were randomly divided into study (n = 42) and control (n = 45) groups. The control group received 12‐week cardiac rehabilitation and routine care. The study group received routine care and cardiac rehabilitation and the 12‐week intervention program developed according to the goal attainment theory, including the mutual goal‐based face‐to‐face guidance, and every‐2‐week telephone follow‐ups. The self‐management behaviour, quality of life, unscheduled readmission rate, and satisfaction of patients were examined. Results: For the patients subjected to the developed continuous nursing program based on mutual goals, achievement rates of all dimension mutual goals were at high levels (from 80.21% to 98.41%), except for the weight control (60.94%). Moreover, according to the comparable base data, compared with the control group, the self‐management behaviour (study group 93.43 vs. control group 76.00), quality of life (QoL), and patients' satisfaction (study group 4.64 vs. control group 4.11) were higher, while the unscheduled readmission rate (study group 4.76% vs. control group 22.22%) was lower, in the study group, with statistically significant differences. [ABSTRACT FROM AUTHOR]

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

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

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

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

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

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

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

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

Over the past decades, a number of complementary treatments for schizophrenia have emerged. One of these is metacognitive training (MCT), which combines the principles of cognitive‐behavioral therapies, cognitive remediation, and psychoeducation into a hybrid approach placing emphasis on increasing metacognitive awareness. The aim of our study was to investigate the efficacy of MCT on symptom severity, and neurocognitive and social cognitive functioning in schizophrenia; also, attention was paid to the assessment of subjective acceptability. Forty‐six patients diagnosed with schizophrenia were included in our single‐blind randomized controlled trial, who were assigned to the intervention or control group. The intervention group was provided standard MCT, while the control group received treatment as usual. We assessed symptom severity and cognitive functions before and after the training, as well as after a 6‐month follow‐up period. Compared to the control group, the intervention group showed improvement in overall symptom severity, and positive and disorganized symptoms. Training participans showed further improvement at the follow‐up assessment. Regarding neurocognitive functions, improvement in visuospatial functions was observed between pre‐ and post‐intervention assessments compared to the control group. Patients showed excellent adherence, and evaluated the training as useful and interesting. In line with the results of previous studies, our results demonstrate the efficacy of MCT on symptom severity in schizophrenia. Improvements in cognitive functions that are closely related to the onset and prevalence of symptoms of schizophrenia were also found. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study evaluated the effect of the school‐based intervention Charge Your Brainzzz on adolescents' social‐cognitive determinants, sleep hygiene and sleep duration and quality. METHODS: A cluster‐randomized controlled trial was conducted with 972 students from 10 Dutch high schools. Schools were randomly allocated to the intervention (N = 5) or control condition (N = 5). Outcomes were measured with the digital Consensus Sleep Diary and via a digital questionnaire, based on valid measures. Data were collected at baseline (T0), ±1.5 weeks post‐intervention (T1) and ±3 months post‐intervention (T2). Mixed model analyses were performed to estimate the effects on social‐cognitive determinants, sleep hygiene, and sleep outcomes. RESULTS: The intervention increased sleep knowledge post‐intervention (b = 1.91; 95%CI: 1.22‐2.60) and at follow up (b = 1.40; 95%CI: 0.70‐2.10). The intervention was also effective in changing adolescents' attitudes (b = 0.10; 95%CI: 0.01‐0.19) and perceived behavioral control (b = 0.11; 95%CI: 0.01‐0.22) post‐intervention. No positive changes were found regarding subjective norms, behavioral intentions, sleep hygiene, or sleep outcomes. CONCLUSIONS: The intervention improved adolescents' sleep knowledge, attitude, and perceived behavioral control. To significantly impact sleep health, theoretically sound and systematically developed interventions are needed which take into account the interplay between sleep, sleep‐related behaviors, and adolescents' social and physical environment. CLINICAL TRIAL REGISTRATION: Trial name: Evaluation of the school‐based intervention Charge Your Brainzzz promoting sleep in adolescents; URL: https://doi.org/10.1186/ISRCTN36701918; ID: ISRCTN36701918. [ABSTRACT FROM AUTHOR]

Summary: Background: Few randomized controlled trial (RCT) interventions targeted children's early risk behaviours using telephone or short message service (SMS) support. Objective: To evaluate the effectiveness of telephone or SMS early intervention focusing on mothers' behaviours starting from late pregnancy to improve BMI, and eating and screen time behaviours of children aged 2 years in comparison with the control group. Methods: A 3‐arm RCT was conducted in Australia, 2017–2019. Two arms involved the interventions using nurse‐led telephone or SMS support, delivered in nine stages from late pregnancy to age 2 years. The third arm was control. The primary outcome was children's objectively measured BMI and BMI z‐score at 2 years. Secondary outcomes included child eating and screen time behaviours as reported by parents at 2 years. Results: At 2 years, 797 mother–child dyads (69%) completed the telephone survey with 666 (58%) completing weight and height measurements. The study found no statistically significant difference in BMI between the groups. The mean BMI for telephone support was 16.93 (95% CI: 16.73 to 17.13), for SMS 16.92 (95% CI: 16.73 to 17.11) or for control 16.95 (95% CI: 16.73 to 17.16) with a difference of −0.02 (95% CI: −0.31 to 0.27, p = 0.907) in telephone versus control, and a difference of −0.03 (95% CI: −0.30 to 0.24, p = 0.816) in SMS versus control. Telephone support was associated with higher odds of no bottle at bedtime (adjusted odds ratio [AOR]: 2.99; 95% CI: 2.01 to 4.47), family meals (AOR: 2.05; 95% CI: 1.26 to 3.33), drinking from a cup (AOR: 1.89; 95% CI: 1.24 to 2.88), less screen time (<1 h/day) (AOR: 1.56; 95% CI: 1.10 to 2.23) and not eating dinner in front of the TV (AOR: 1.50; 95% CI: 1.09 to 2.06). SMS support was also associated with higher odds of no bottle at bedtime (AOR 2.30, 95% CI: 1.58 to 3.33) than the control. Conclusion: The telephone or SMS support intervention had no significant effects on BMI, but was effective in increasing no bottle use at bedtime. Telephone support showed more effects than SMS on reducing screen time and eating behaviours. [ABSTRACT FROM AUTHOR]

Aim: To test whether soft‐type block bone substitute used for guided bone regeneration (GBR) of peri‐implant defects leads to a different dimension of the augmented hard tissue than particulate bone substitute. Materials and Methods: In 40 patients, 40 two‐piece dental implants were placed >2 months after tooth extraction. Following random allocation, 20 peri‐implant bone dehiscences were grafted with a soft‐type block made of synthetic biphasic calcium phosphate (BCP) + collagen and 20 bone dehiscences with particulate BCP. All the sites were covered with a collagen membrane stabilized with titanium pins. Immediately after wound closure and after 6 months, the horizontal dimension (HD) of the augmented hard tissue was measured at the level of implant shoulder using cone beam computed tomography. During re‐entry at 6 months, the defect fill was clinically assessed. Results: At 6 months, the median HD measured 1.15 mm (mean: 1.31 mm) in the soft‐block group and 0.93 mm (mean: 1.05 mm) in the particulate group (p =.6). At 6 months, 7.1% of contained defects and 61.9% of non‐contained defects showed an incomplete vertical defect fill. Conclusions: Soft‐type block of BCP + collagen used for GBR of peri‐implant defects did not differ from particulate BCP regarding the dimension of the augmented hard tissue after 6 months of healing. [ABSTRACT FROM AUTHOR]

Objectives: To compare a designated shared oral care intervention in a group of public nursing home residents with a standard oral care programme, focusing on levels of oral plaque and oral inflammation. Methods: A cluster randomized field trial was undertaken in 14 Danish public nursing homes. There were 145 participants included in the intervention group and 98 in the control group. We undertook a six‐month intervention based on the principle of situated interprofessional learning. The primary outcomes were plaque and inflammation levels measured with the mucosal plaque index (MPS); this was assessed at baseline, after three and six months (end of intervention), and at follow‐up (six months postintervention). The odds ratios (OR) and 95% confidence intervals (CI) were estimated with ordinal regression. Results: Socio‐demographic characteristics and oral health status at baseline were comparable between the two groups, with the exception of age: the intervention group were significantly younger than controls (median 82 vs 87 years). After three and six months, those receiving the shared oral care intervention had significantly lower plaque and inflammation than the control group. The adjusted ORs for a reduction in MPS were 11.8 (CI: 6.5‐21.3) and 11.0 (CI: 5.8‐20.9), respectively. At follow‐up, plaque levels and oral inflammation had approached the pre‐intervention level, with no remaining statistically significant group differences. Conclusions: The shared oral care intervention based on a situated learning perspective was effective in improving oral health among care home residents. However, after termination of the intervention, the effect quickly decreased. This confirms the challenges of achieving long‐term improvement in oral health in nursing home residents. An implementation strategy focusing on achieving changes at both organizational and individual levels with persistent attention to oral health care seem required for long‐term improvement. [ABSTRACT FROM AUTHOR]

Literature suggests that acceptance and commitment therapy (ACT) is effective in improving well‐being and in reducing psychopathological symptoms commonly experienced by people with chronic illness (CI). Compassion‐focused therapy (CFT) reduces psychological distress, especially in individuals with high levels of shame and self‐criticism, but few studies have explored CFT in CI. Additionally, studies almost exclusively compared ACT and CFT with inactive controls (wait‐list; treatment as usual). Also, there is an interest in developing cost‐effective mental health solutions, such as low‐intensity online psychological interventions. This randomized controlled trial (RCT) aimed to assess the acceptability and compare the efficacy of four‐session online ACT (n = 25) and CFT (n = 24) interventions in a sample of people with CI. Results showed both interventions were acceptable, with attrition rates at post‐intervention comparable to those found in similar studies (around 50%). Intention‐to‐treat analyses showed that participants presented significantly less illness‐related shame, less uncompassionate self‐responding and more valued living after the intervention, although no difference was found between conditions. Results were sustained at 3‐ and 6‐month follow‐up. Results did not find statistical differences between conditions through reliable change index (RCI). Correlation between demographics and RCI showed that, at post‐intervention, younger participants presented more behavioural awareness, men presented more valued action, and participants with CI for shorter periods presented less uncompassionate self‐responding and less anxiety. Results suggest that low‐intensity (four sessions) online ACT and CFT are cost‐effective approaches to promote mental health of individuals with CI. Results and limitations are thoroughly discussed. [ABSTRACT FROM AUTHOR]

Background: Retirement villages (RVs), also known as continuing care retirement communities, are an increasingly popular housing choice for older adults. The RV population has significant health needs, possibly representing a group with needs in between community‐dwelling older adults and those in long‐term residential care (LTC). Our previous work shows Gerontology Nurse Specialist (GNS)‐facilitated multidisciplinary team (MDT) interventions may reduce hospitalizations from LTC. This study tested whether a similar intervention reduced hospitalizations in RV residents. Methods: Open‐label randomized controlled trial in which 412 older residents of 33 RVs were randomized (1:1) to an MDT intervention or usual care. Setting: RVs across two District Health Boards in Auckland, New Zealand. Residents were eligible if considered high risk of health/functional decline (triggering ≥3 interRAI Clinical Assessment Protocols or needing special consideration identified by GNS). Intervention: GNS‐facilitated MDT intervention, including geriatrician/nurse practitioner and clinical pharmacist, versus usual care. Primary outcome was time from randomization to first acute hospitalization. Secondary outcomes were rate of acute hospitalizations, LTC admission, and mortality. Twelve residents died before randomization; all others (n = 400: MDT intervention = 199; usual care = 201) were included in intention‐to‐treat analyses. Results: Mean (SD) age was 82.2 (6.9) years, 302 (75.5%) were women, and 378 (94.5%) were European. Over median 1.5 years follow‐up, no difference was found in hazard of acute hospitalization between the MDT intervention (51.8%) and usual care (49.3%) groups (Hazard ratio [HR] = 1.01, 95% CI = 0.77–1.34). No difference was found in the incidence rate of acute hospitalizations between the MDT intervention (0.69 per person‐year) and usual care (0.86 per person‐year) groups (incidence rate ratio = 0.81, 95% CI = 0.59–1.10). Similar results were seen for the proportion of residents with LTC transition (HR = 1.18, 95% CI = 0.65–2.11) and mortality (HR = 0.70, 95% CI = 0.36–1.35). Conclusion: Further studies are needed to assess the effects of other patient‐centered interventions and outcomes with adequate primary care integration. [ABSTRACT FROM AUTHOR]

People with diabetes frequently have elevated diabetes distress. Although mindfulness‐based stress reduction (MBSR) therapy has been shown effective in reducing diabetes distress, it has only been delivered by psychologists or a multidisciplinary team with an attrition rate of up to 39%, which limits its dissemination to a broader audience. This study was aimed to pilot evaluate the feasibility of a nurse‐led MBSR therapy and explore its potential efficacy amongst people with type 2 diabetes mellitus. A total of 100 participants were randomly allocated either to the intervention group (nurse‐led MBSR therapy + regular diabetes education) or the control group (regular diabetes education). Data on diabetes distress, diabetes self‐efficacy, and diabetes self‐management were collected at baseline, 8 and 12 weeks. Hemoglobin A1c (HbA1c) was collected at baseline and 12 weeks. A generalized estimating equation analysis for repeated measures was used to determine intervention and time effects. As predicted, the nurse‐led MBSR therapy had a significant time‐by‐group interaction effect on diabetes distress total score (95% confidence interval [CI]: 0.58–0.77, p < 0.001), diabetes self‐efficacy (95% CI: −0.93 to −0.74, p < 0.001), diabetes self‐management (95% CI: −10.80 to −7.83, p < 0.001), and HbA1c levels (95% CI: 0.04–1.14, p = 0.03) in the intervention group compared with the control group over 12 weeks. This is the first nurse‐led MBSR therapy in a hospital setting that is feasible and has the potential to improve health outcomes. This approach may offer an innovative model to deliver MBSR therapy. A randomized controlled trial comparing the nurse‐led MBSR plus usual diabetes education with usual diabetes education along with a mechanism to equalize intervention attention between the groups is indicated. [ABSTRACT FROM AUTHOR]

Background: Compensational movement patterns in hip osteoarthritis (HOA) are associated with hip dysfunction. Basic Body Awareness Therapy (BBAT) promotes functional movement quality and might, accordingly, be beneficial in HOA. Objective: To examine the outcomes of BBAT compared to standard care in people with HOA after first receiving patient education (PE). Study Design: A prospective, assessor‐blinded, and block‐randomized controlled trial. Methods: Community‐living adults with HOA participating in PE were randomly allocated to an intervention group receiving BBAT in groups (12 sessions offered once a week), or a comparison group. Data at baseline (pretest) and at 6 months (posttest) were analyzed. Primary outcomes were pain during walking assessed by the Numeric Rating Scale (NRS) and function by the Hip Osteoarthritis Outcome Score, subscale ADL (HOOS A). Secondary outcomes addressed physical capacity, movement quality, and self‐reported aspects of function and health. Results: At pretest, there were no significant differences in demographic and test data between the intervention (n = 51) and the comparison (n = 50) group. Forty‐one intervention and 45 comparison participants completed the posttest. At posttest, no significant differences in change between groups were found on NRS (p = 0.694, effect size (ES) = 0.02) or HOOS A (p = 0.783, ES = 0.07). Among secondary outcomes, movement quality improved significantly more (p < 0.001, ES = 0.84) in the intervention group. Compliance with BBAT varied substantially. Per‐protocol analysis showed changes in favor of the intervention group for self‐efficacy (p = 0.049, ES = 0.36), health (p = 0.037, ES = 0.44), and function (p = 0.029, ES = 0.53) when only intervention participants who completed at least 10 sessions of BBAT were included. Conclusions: BBAT was not found to be a more effective treatment modality than self‐initiated standard care to reduce pain during walking and improve daily functioning in people with HOA. Movement quality was significantly more improved in participants receiving BBAT, and improvement in other health aspects was associated with sufficient therapy compliance. [ABSTRACT FROM AUTHOR]

Background and aims: The majority of smokers accessing the current best treatments continue to smoke. We aimed to test if e‐cigarettes (EC) compared with nicotine replacement treatment (NRT) can help such smokers to reduce smoking. Design Randomized controlled trial of EC (n = 68) versus NRT (n = 67) with 6‐month follow‐up. Setting: Stop smoking service in London, UK. Participants: A total of 135 smokers (median age = 40 years, 51% male) previously unable to stop smoking with conventional treatments. Interventions: Participants received either NRT of their choice (8‐week supply) or an EC starter pack and instructions to purchase further e‐liquids of strength and flavours of their choice themselves. Products were accompanied by minimal behavioural support. Measurements Participants who reported that they stopped smoking or reduced their daily cigarette consumption by at least 50% at 6‐month follow‐up were invited to provide a carbon monoxide (CO) reading. The primary outcome was biochemically validated reduction in smoke intake of at least 50% at 6 months and the main secondary outcome was sustained validated abstinence at 6 months. Drop‐outs were included as 'non‐reducers'. Findings Validated smoking reduction (including cessation) was achieved by 26.5 versus 6.0% of participants in the EC and NRT study arms, respectively [relative risk (RR) = 4.4, P = 0.005, 95% confidence interval (CI) = 1.6–12.4]. Sustained validated abstinence rates at 6 months were 19.1 versus 3.0% (RR = 6.4, P = 0.01, 95% CI = 1.5–27.3). Product use was high and equal in both study arms initially, but at 6 months allocated product use was 47% in the EC arm versus 10% in the NRT arm (χ2(1) = 22.0, P < 0.001), respectively. Adverse events were minor and infrequent. Conclusions: In smokers unable to quit using conventional methods, e‐cigarettes were more effective than nicotine replacement therapy in facilitating validated long‐term smoking reduction and smoking cessation when limited other support was provided. [ABSTRACT FROM AUTHOR]

Background: Spinal cord stimulation (SCS) is a well‐established treatment for chronic intractable pain of the trunk and/or limbs; however, low back pain (LBP) is difficult to treat using traditional SCS. Differential Target Multiplexed spinal cord stimulation (DTM SCS) is an advanced approach inspired from animal studies demonstrating improved pain‐related behavior and pain‐relevant biological processes. Objective: The purpose of this study was to compare the effectiveness of DTM SCS and traditional SCS in treating chronic LBP and leg pain (LP). Methods: This prospective, postmarket randomized controlled trial compared DTM SCS to traditional SCS in patients with chronic LBP and LP. Primary end point was LBP responder rate (percentage of subjects with ≥ 50% relief) at 3 months. Noninferiority and superiority were assessed. Other outcomes included mean change in back and leg pain, responder rates, disability, global health, satisfaction, and safety profile throughout the 12‐month follow‐up. Results: One hundred twenty‐eight subjects were randomized across 12 centers (67 DTM SCS and 61 traditional SCS). Of the 94 patients implanted, 46 subjects in each group completed the 3‐month assessment. LBP responder rate of 80.1% with DTM SCS was superior to 51.2% with traditional SCS (p = 0.0010). Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (p < 0.0001). These results were sustained at 6 months and 12 months. Safety profiles were similar between treatment groups. Conclusion: Superiority of DTM SCS compared with traditional SCS for chronic LBP was demonstrated. Clinical improvements provided by DTM SCS were sustained over 12 months and are expected to significantly impact the management of chronic LBP. [ABSTRACT FROM AUTHOR]