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Objective: Conventional randomized controlled trials (RCTs) have long served as the foundation of research in clinical psychology; however, most treatments for eating disorders show only modest effects on reduction of symptoms and maintenance of long‐term remission. New options for psychotherapy treatment development research, beyond continuing to pursue additive or subpopulation approaches, are needed. Methods: One option is to apply dose–response designs, which are commonplace in studies of pharmacology, toxicology, and medical research, and characterized by the evaluation of the amount of exposure (dose) to an intervention, and the resulting changes in body function or health (response). Results: Eating disorder interventions are particularly well‐suited for dose–response treatment designs. The deadly nature of eating disorders makes it imperative that patients are not turned away for not being "ready" to engage with treatment. By identifying optimal doses, research will likely yield a more parsimonious course of treatment, which will lend itself to reduced costs, greater uptake, and reduced drop‐out. Discussion: Limited use of within‐subject designs in trials for patients with eating disorders has produced fast‐track efficacy studies and omitted key elements in the treatment development pathway. To decrease reliance on RCT's, dose–response methods should be applied as an alternative study design. Public Significance: Eating disorders are associated with medical and psychiatric comorbidities, poor quality of life, and high mortality. Access to evidence‐based services for patients with eating disorders is limited, and identifying additional effective treatment options can be difficult because of challenges inherent to randomized‐controlled trials. This manuscript describes an alternative trial methodology to maximize the information that can be gathered prior to utilizing a standard large‐scale efficacy design. [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]

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

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]

Aim: This study aimed to develop a mobile application for improving self‐management and to evaluate its effects in adult patients on peritoneal dialysis (PD). Methods: This randomized controlled trial was registered with the Korean Clinical Research Information Service Registry (KCT0007267) and conducted at a tertiary hospital. A self‐management mobile application (SMA) was developed based on social cognitive theory and the ADDIE (analysis, design, development, implementation, and evaluation) model. The SMA includes information about disease management; self‐recording of data on diet, exercise, medication, and health behavior; and healthcare providers' support and feedback. Participants aged 19–65 years were randomly allocated to the intervention group (n = 27) using the SMA for 10 weeks, and the control group (n = 26) receiving usual care. PD‐related knowledge and self‐efficacy, PD‐related health behavior, biomarkers, and health‐related quality of life (HRQoL) were surveyed pretest/posttest and analyzed using SPSS 23.0. Results: Compared to the controls, the intervention group showed significant improvement in PD‐related knowledge and health behavior, albumin, and hemoglobin. HRQoL domains of symptoms/problems of kidney disease and disease impact on daily activity were improved in the intervention group. Conclusion: The SMA is an effective intervention for enhancing health behaviors as well as improving the HRQoL of patients with PD. Without any limitations on time or location, patients with PD can easily use the SMA to monitor their health conditions, efficiently manage their disease, and perform PD‐related behaviors. Nurses can implement high‐quality tailored healthcare by using patients' lifelog data from the SMA. [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]

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

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]

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]

Objective: Eating disorders (EDs) are serious mental illnesses with high mortality and relapse rates and carry significant societal and personal costs. Nevertheless, there are few evidence‐based treatments available. One aspect that makes treatment difficult is the high heterogeneity in symptom presentation. This heterogeneity makes it challenging for clinicians to identify pertinent treatment targets. Personalized treatment based on idiographic models may be well‐suited to address this heterogeneity, and, in turn, presumably improve treatment outcomes. Methods: In the current randomized controlled trial, participants will be randomly assigned to either 20 sessions of enhanced cognitive behavioral therapy (CBT‐E) or transdiagnostic network‐informed personalized treatment for EDs (T‐NIPT‐ED). Assessment of ED symptoms, clinical impairment, and quality of life will occur at pre‐, mid‐, posttreatment, and 1‐month follow‐up. Results: We will examine the acceptability and feasibility of T‐NIPT‐ED compared to CBT‐E. We also will test the initial clinical efficacy of T‐NIPT‐ED versus CBT‐E on clinical outcomes (i.e., ED symptoms and quality of life). Finally, we will test if the network‐identified precision targets are the mechanisms of change. Discussion: Ultimately, this research may inform the development and dissemination of evidence‐based personalized treatments for EDs and serve as an exemplar for personalized treatment development across the broader field of psychiatry. Public Significance: Current evidence‐based treatments for eating disorders result in low rates of recovery, especially for adults with AN. Our study aims to test the feasibility, acceptability, and clinical efficacy of a data‐driven, individualized approach to ED treatment, network‐informed personalized treatment, compared to the current evidence‐based treatment for EDs, Enhanced CBT. Findings have the potential to improve treatment outcomes for EDs by identifying and targeting core symptoms maintaining EDs. [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]

In a randomized controlled trial (RCT), it is possible to improve precision and power and reduce sample size by appropriately adjusting for baseline covariates. There are multiple statistical methods to adjust for prognostic baseline covariates, such as an ANCOVA method. In this paper, we propose a clustering‐based stratification method for adjusting for the prognostic baseline covariates. Clusters (strata) are formed only based on prognostic baseline covariates, not outcome data nor treatment assignment. Therefore, the clustering procedure can be completed prior to the availability of outcome data. The treatment effect is estimated in each cluster, and the overall treatment effect is derived by combining all cluster‐specific treatment effect estimates. The proposed implementation of the procedure is described. Simulations studies and an example are presented. [ABSTRACT FROM AUTHOR]

A nonblinded randomized trial was conducted at two Canadian provincial outpatient addiction clinics that tested the effectiveness of a systemic congruence couple therapy (CCT) versus individual‐based treatment‐as‐usual (TAU) on nine clinical outcomes: (1) primary outcomes—alcohol use and gambling, psychiatric symptoms, and couple adjustment; (2) secondary outcomes—emotion regulation, substance use, depression, post‐traumatic stress symptoms, and life stress. Data of primary clients and partners (N = 46) were analyzed longitudinally across baseline, posttreatment (5 months), and follow‐up (8 months). Alcohol use disorder (95%) and gambling disorder (5%) were in the severe range at baseline, and co‐addiction was 27%. Psychiatric comorbidity was 100%, and 18% of couples were jointly addicted. Between‐group comparison favored CCT in primary outcomes with medium‐to‐large effect sizes (Cohen's h = 0.74–1.44). Secondary outcomes were also significantly stronger for CCT (Cohen's h = 0.27–1.53). Within‐group, for all primary outcomes, a significant proportion of symptomatic CCT clients and partners improved, converging with ANOVA results of large effect sizes (0.14–0.29). All secondary outcomes improved significantly in CCT with large effect sizes (0.14–0.50). TAU showed significant within‐group improvement in alcohol use, other substance use, and life stress with large effect sizes (0.16–0.40). Primary clients and partners made largely equivalent improvement within CCT and within TAU. Results were triangulated with clients' satisfaction ratings and counselors' reports. Overall, significant within‐group effects were detected for CCT both clinically and statistically and between‐group difference favored CCT. Future trials are required to validate these promising findings. [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]

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]

Aim: To assess the effect of periodontal treatment on HbA1c and diagnostic parameters of patients with metabolic syndrome (MetS). Materials and Methods: One hundred and fifty‐eight patients with MetS and moderate and severe periodontitis were included. They were randomized into a test group (n = 79), which received non‐surgical periodontal treatment, and a control group (n = 79), which received no treatment. Medical treatment was delivered to both groups. Clinical periodontal, anthropometric and serological parameters were assessed at baseline, 3 and 6 months. The main outcome was glycated haemoglobin (HbA1c) levels, and the secondary outcomes were changes in the MetS parameters, C‐reactive protein (CRP) and HOMA indexes. Results: Significant reductions in all periodontal parameters were observed in the test group, compared with the control group, at 3 and 6 months (p <.001). HbA1c levels, MetS parameters, CRP and HOMA indexes showed no significant differences between the test group and the control group at 3 and 6 months. Conclusions: Periodontal treatment led to a substantial reduction in periodontal inflammation, although there was no significant effect on the parameters used for MetS diagnosis in patients with early diagnosed and well‐controlled MetS. [ABSTRACT FROM AUTHOR]

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

Background 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]

Objectives: Research on effectiveness and cost‐effectiveness of longstanding exercise therapy in patients with axial SpondyloArthritis (axSpA) or Rheumatoid Arthritis (RA) is scarce, and mainly concerned patients with a relatively favorable health status. We aim to evaluate the effectiveness and cost‐effectiveness of longstanding exercise therapy compared to usual care in the subgroup of patients with axSpA or RA and severe limitations in functioning. Methods: In two separate, parallel randomized controlled trials the effectiveness and cost‐effectiveness of longstanding, active exercise therapy (52 weeks) compared with usual care (1:1) will be evaluated. The longstanding, active exercise therapy will focus on improving individual limitations in daily activities and participation and will be given by a trained physical therapist in the vicinity of the participant. For each diagnosis, 215 patients with severe limitations in activities and participation will be included. Assessments are performed at baseline, 12, 26, and 52 weeks. The primary outcome measure of effectiveness is the individual level of functioning (activities and participation), as measured with the Patient‐Specific Complaints instrument at 52 weeks. For cost‐effectiveness analyses, the EuroQol (EQ‐5D‐5L) and questionnaires on healthcare use and productivity will be administered. The economic evaluation will be a cost‐utility analysis from a societal perspective. After 52 weeks, the patients in the usual care group are offered longstanding, active exercise therapy as well. Follow‐up assessments are done at 104, 156, and 208 weeks. Conclusion: The results of these studies will provide insights in the effectiveness and cost‐effectiveness of longstanding exercise therapy in the subgroup of axSpA and RA patients with severe functional limitations. [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]

Objective: Knowledge on gut–brain interaction might help to develop new therapies for patients with anorexia nervosa (AN), as severe starvation‐induced changes of the microbiome (MI) do not normalise with weight gain. We examine the effects of probiotics supplementation on the gut MI in patients with AN. Method: This is a study protocol for a two‐centre double‐blind randomized‐controlled trial comparing the clinical efficacy of multistrain probiotic administration in addition to treatment‐as‐usual compared to placebo in 60 patients with AN (13–19 years). Moreover, 60 sex‐ and age‐matched healthy controls are included in order to record development‐related changes. Assessments are conducted at baseline, discharge, 6 and 12 months after baseline. Assessments include measures of body mass index, psychopathology (including eating‐disorder‐related psychopathology, depression and anxiety), neuropsychological measures, serum and stool analyses. We hypothesise that probiotic administration will have positive effects on the gut microbiota and the treatment of AN by improvement of weight gain, gastrointestinal complaints and psychopathology, and reduction of inflammatory processes compared to placebo. Conclusions: If probiotics could help to normalise the MI composition, reduce inflammation and gastrointestinal discomfort and increase body weight, its administration would be a readily applicable additional component of multi‐modal AN treatment. Key points: Patients with anorexia nervosa face profound alterations of the gut microbiome which does not normalise with weight gain.Alterations in the gut microbiome in patients with anorexia nervosa are linked to psychopathological symptoms and neurophysiological deficits, for example, related to the reward system.This is the first study examining the effects of probiotics administration in adolescents with anorexia nervosa using a randomized controlled trial design. [ABSTRACT FROM AUTHOR]

Background: Nasal valve collapse is one of several causes of nasal obstruction. The safety and efficacy of a temperature‐controlled radiofrequency (RF) device for the treatment of the nasal valve for nasal airway obstruction (NAO) has been established in single‐arm studies. The objective of this trial was to compare active device treatment against a sham procedure (control). Methods: In a prospective, multicenter, single‐blinded, randomized controlled trial (RCT), patients were assigned to bilateral temperature‐controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area. The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall. The primary endpoint was responder rate at 3 months, defined as a ≥20% reduction in Nasal Obstruction Symptom Evaluation (NOSE)‐scale score or ≥1 reduction in clinical severity category. Results: At baseline, patients had a mean NOSE‐scale score of 76.7 (95% confidence interval [CI], 73.8 to 79.5) and 78.8 (95% CI, 74.2 to 83.3) (p = 0.424) in the active treatment and sham‐control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3% [95% CI, 79.2%‐93.7%] vs 42.5% [95% CI, 28.5%‐57.8%]; p < 0.001). The active treatment arm had a significantly greater decrease in NOSE‐scale score (mean, −42.3 [95% CI, −47.6 to −37.1] vs −16.8 [95% CI, −26.3 to −7.2]; p < 0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved. Conclusion: This RCT shows temperature‐controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short‐term follow‐up. [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]

Aim: To evaluate the outcomes of an apically repositioned flap (ARF) plus xenogeneic collagen matrix (XCM) in augmenting keratinized mucosa width (KMW) around dental implants when compared with ARF plus free gingival grafts (FGG). Materials and methods: Twenty‐six participants with at least one site with KMW ≤2 mm were randomized into FGG or XCM group. Clinical examinations were performed at baseline and at 2 and 6 months after surgery, including KMW, keratinized mucosa thickness, gingival index (GI), and probing depth (PD). Post‐operative pain and patient satisfaction were also evaluated. Results: At 6 months, FGG attained a greater increase of KMW and thicker mucosa than XCM (4.1 ± 1.6 mm vs. 1.8 ± 1.0 mm, p <.001; 1.7 ± 0.6 mm vs. 1.2 ± 0.3 mm, p <.01). Regarding GI, PD, post‐operative pain, aesthetic outcomes, and patient satisfaction, no significant difference could be detected. Moreover, the operation time of XCM group was shorter (60 ± 9 min vs. 39 ± 8 min, p <.001). Conclusions: FGG could result in greater increase of KMW than XCM, though both could increase KMW, maintain peri‐implant health, and attain comparable aesthetic outcomes. The use of XCM was associated with reduced operation time. [ABSTRACT FROM AUTHOR]

Objectives: Individuals with major depressive disorder (MDD) have problems with engaging in approach behaviour to potentially rewarding encounters, which contributes to the maintenance of depressive symptoms. Approach‐avoidance training (AAT) retrains implicit approach tendencies, and behavioural activation (BA) promotes explicit approach behaviour in MDD. As a novel MDD treatment strategy, this study aimed to implement a brief, computerized version of BA integrated with implicit AAT. Design: Adults with a principal diagnosis of MDD (N = 25) were randomly assigned to complete one of two versions of AAT – approach‐positive faces (n = 12) or balanced approach of positive and neutral faces (n = 13) – concurrently with self‐guided BA twice weekly for 2 weeks. Methods: Outcomes included treatment completion rates; bias scores for automatic approach towards positive social cues; and symptom scales for depression, positive affect, social relationship functioning, anhedonia, and anxiety. Results: Feasibility and acceptability of computerized BA + AAT were supported by moderate pre‐treatment credibility and expectancy ratings and 80% treatment completion. Participants across both conditions displayed significant and large sized reductions in depression from pre‐ to post‐assessment (Cohen's d = −1.23) that maintained three months later, as well as decreased anxiety and anhedonia and increased positive affect and social relationship functioning (medium to large effects). Conclusion: Results support the feasibility and potential efficacy of brief, computerized BA + AAT. Research is needed to determine whether AAT is additive to BA, and what AAT parameters best enhance treatment outcomes. Practitioner Points: Brief, computerized behavioral activation plus approach/avoidance training (BA + AAT) may be acceptable and beneficial for some patients with moderate‐to‐severe major depression.Computer‐delivered BA + AAT can be implemented as a largely self‐guided program for MDD and could be administered remotely and/or with minimal clinician interaction.As this was a small proof of concept study, it cannot be determined which treatment components – AAT, BA, or both – contributed to positive clinical outcomes.Because BA + AAT was implemented in a research clinic, it remains unknown what treatment engagement and response would look like in community settings. [ABSTRACT FROM AUTHOR]

Aims: To assess the effectiveness of training stop smoking services providers in Malaysia to deliver support for smoking cessation based on the UK National Centre for Smoking Cessation and Training (NCSCT) standard treatment programme compared with usual care. Design Two‐arm cluster‐randomized controlled effectiveness trial across 19 sites with follow‐up at 4‐week, 3‐month, and 6‐month. Setting: Stop smoking services operating in public hospitals in Malaysia. Participants: Five hundred and two smokers [mean ± standard deviation (SD), age 45.6 (13.4) years; 97.4% male] attending stop smoking services in hospital settings in Malaysia: 330 in 10 hospitals in the intervention condition and 172 in nine hospitals in the control condition. Intervention and comparator: The intervention consisted of training stop‐smoking practitioners to deliver support and follow‐up according to the NCSCT Standard Treatment Programme. The comparator was usual care (brief support and follow‐up). Measurements: The primary outcome was continuous tobacco smoking abstinence up to 6 months in smokers who received smoking cessation treatment, verified by expired‐air carbon monoxide (CO) concentration. Secondary outcomes were continuous CO‐verified tobacco smoking abstinence up to 4 weeks and 3 months. Results: Follow‐up rates at 4 weeks, 3 months and 6 months were 80.0, 70.6 and 53.3%, respectively, in the intervention group and 48.8, 30.8 and 23.3%, respectively, in the control group. At 6‐month follow‐up, 93 participants in the intervention group and 19 participants in the control group were abstinent from smoking, representing 28.2 versus 11.0% in an intention‐to‐treat (ITT) analysis assuming that participants with missing data had resumed smoking, and 52.8 versus 47.5% in a follow‐up‐only (FUO) analysis. Unadjusted odds ratios (accounting for clustering) were 5.04, (95% confidence interval (CI) = 1.22–20.77, P = 0.025) and 1.70, (95% CI = 0.25–11.53, P = 0.589) in the ITT and FUO analyses, respectively. Abstinence rates at 4 week and 3 month follow‐ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis. Conclusions: On an intention‐to‐treat analysis with missing‐equals‐smoking imputation, training Malaysian stop smoking service providers in the UK National Centre for Smoking Cessation and Training standard treatment programme appeared to increase 6 month continuous abstinence rates in smokers seeking help with stopping compared with usual care. However, the effect may have been due to increasing follow‐up rates. [ABSTRACT FROM AUTHOR]

Objective: This randomized clinical trial evaluated the effectiveness and tooth sensitivity (TS) of 37.5% hydrogen peroxide (37.5HP) in‐office bleaching with reduced protocol. Materials and methods: Forty participants with shade mean C2 or darker for the six maxillary anterior teeth were randomly allocated into two treatment groups (n = 20): two (37.5HP2) or three (37.5HP3) 8 min applications/clinical session. Three clinical sessions were performed with a 1 week interval. Color evaluations were done with a spectrophotometer at baseline and 1 week post‐bleaching. TS was measured during and up to 48 h after bleaching using a five‐point numeric rating scale. Color change was evaluated by Student's t‐test for independent samples. The absolute risk and intensity of TS were analyzed by Fisher's and Mann–Whitney/Friedman tests (p < 0.05). Result Both treatment groups resulted in a significant tooth whitening 1 week post‐bleaching (p < 0.001). There were no significant differences between 37.5HP2 and 37.5HP3 for ΔE*ab, ΔE00 and ∆WID. Also, there were not differences between groups regarding high absolute risk (p = 1.0) and low intensity of TS at all time assessments (p > 0.7). Conclusions: The in‐office bleaching with two 37.5% HP applications produced the same whitening degree, risk and intensity of TS to that performed with three gel applications. Clinical significance: Clinicians should opt to use a neutral 37.5% HP in‐office bleaching gel for two 8 min applications/clinical session because produces the same whitening effectiveness, risk and low intensity of TS as the protocol proposed by manufacturer (three 8 min applications). [ABSTRACT FROM AUTHOR]

Self‐reported physical activity differs from activity levels measured by device. We tested the effect of a video that visualizes the intensity levels of physical activity to increase the agreement between self‐reported and accelerometer‐based moderate‐to‐vigorous physical activity (MVPA) within a single‐blinded, randomized study. Participants (N = 378, 40‐75 years) wore an accelerometer for seven days. Prior to the collection of self‐reported data by the IPAQ‐SF, participants were randomly assigned (1:1) to a control group (CG) or a video group (VG). The outcome was the absolute difference between self‐reported and accelerometer‐based time spent in MVPA (Δ MVPAIPAQ−Accelerometry). To examine the agreement, we used Spearman correlation coefficients and Bland‐Altman analysis. To test the video effect, we used Wilcoxon signed‐rank test, Bayes factor, and simultaneous‐quantile regression. In total, 302 participants fulfilled the accelerometer wear time criteria (≥10 hours/day; ≥6 days) and completed self‐reports within three days after the wearing period. The median of Δ MVPAIPAQ−Accelerometry was −9.0 min/day (IQR: −32.0 to 66.6) for CG and −11.5 min/day (IQR: −29.9 to 14.3) for VG. Wilcoxon signed‐rank test revealed no differences in Δ MVPAIPAQ−Accelerometry between study groups whereas Bayes factor indicated insensitivity of the data. Simultaneous‐quantile regression revealed no relationship between video presentation and Δ MVPAIPAQ−Accelerometry in the 25th percentile. In the 50th (b = −12.4 [95% CI = −23.2 to −1.5] and 75th percentile (b = −45.7 [95% CI = −70.5 to −20.9]), Δ MVPAIPAQ−Accelerometry was negatively associated with video presentation. To conclude, video‐supported assessment may increase the accuracy of self‐reported MVPA among individuals who slightly underestimated and those who overestimated their MVPA. [ABSTRACT FROM AUTHOR]

The main aim of this project was to explore the efficacy of Acceptance and Commitment Therapy (ACT)‐based educational course in different formats (i.e., pure and guided self‐help with different durations, and guided self‐help with and without access to a discussion forum) for body shape dissatisfaction. Two randomized controlled studies (RCT) were carried out. In the first RCT, the participants were randomized to a 12‐ or 16‐week guided self‐help, a 16‐week pure self‐help, or a waitlist control condition. In the second RCT, the efficacy of 12‐week guided self‐help with or without access to a discussion forum was investigated. ACT‐based self‐help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self‐esteem, satisfaction with life, and quality of life). The findings also showed no additional effects of support, access to the online discussion forum, and longer duration of self‐help, suggesting the 12‐week self‐help with or without support is a viable option for reducing body shape dissatisfaction. [ABSTRACT FROM AUTHOR]

Background and Aims: Many evidence‐based treatments (EBTs) for substance use disorder (SUD) exist, yet few are tailored to Indigenous patients. This trial tested the efficacy of a culturally tailored EBT that combined Motivational Interviewing and the Community Reinforcement Approach (MICRA) versus treatment as usual (TAU). Design A mixed efficacy/effectiveness randomized controlled trial of MICRA (n = 38) and TAU (n = 41) using a parallel design with follow‐up assessments at 4‐, 8‐, and 12‐ months post baseline. Setting United States, reservation‐based outpatient, addiction specialty care treatment program. Participants: 79 (68% male) American Indian and Alaska Native (AI/AN) Tribal members meeting criteria for SUD and seeking SUD treatment. Interventions: MICRA (individual therapy sessions beginning with MI for 2–3 sessions) compared with TAU (individual and group counseling sessions in a didactic style with Twelve‐Step philosophy and elements of relapse prevention). Measures: Demographics, percent days abstinent (PDA; the primary outcome at 12months assessed by Form 90D), Inventory of Drug Use Consequences, Alcohol and Drug Use Self‐Efficacy Scale, Native American Spirituality Scale, and SCID‐DSM‐IV‐TR. Findings There was no evidence for the benefit of MICRA over TAU (MICRA PDA = 72.63%, TAU = 73.62%, treatment effect: B = −4.04 (SE = 5.47); 95% CI = −14.941, 6.866; BF = 3.44) in the primary outcome. Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12‐month follow‐up. Neither self‐efficacy nor spirituality were significant mediators of MICRA. Conclusions: There were no treatment group differences between culturally tailored evidence‐based treatments for substance use disorder and treatment as usual in this randomized controlled trial with American Indian and Alaska Native participants. Nonetheless, participants improved over time on several substance‐related outcomes. [ABSTRACT FROM AUTHOR]

A large‐scale, cluster‐randomized controlled field trial (Nclassrooms = 47; Nstudents = 1,013) assessed the impact of a digital text‐to‐speech reading material that supported 8‐year‐olds' decoding and reading comprehension. An active control group used the most prevalent Danish learning material with a research‐based systematic, explicit phonics approach supporting primarily decoding. The digital tool allows children to read unfamiliar text for meaning. Students are supported in mapping between orthography and phonology by three levels of text‐to‐speech support and in identifying spelling patterns. The risk of students overusing text‐to‐speech was countered by postponing access to having words read aloud by directing students towards identifying and training relevant orthographic patterns before activating text‐to‐speech. Results showed no statistically significant difference in decoding, but treatment improved reading comprehension. The study demonstrates how digital tools can facilitate strengthening students' decoding skills as efficiently as a traditional phonics‐based programme while students are reading text of relatively high orthographic complexity for meaning. Lay Description: What is already known about this topic: Students must develop both decoding and comprehension skills.It seems that decoding and comprehension develops simultaneously.Digital tools may help to facilitate a balanced reading instruction.Students tend to overuse such text‐to‐speech technologies. What this paper adds: Digital learning tool supporting 2nd graders' decoding and comprehension is tested.The tool uses text‐to‐speech but counters student overuse of text‐to‐speech.RCT had an active control group using a phonics‐based textbook.Results show advantage on comprehension and no difference on decoding. The implications of study findings for practitioners: Students can strengthen both decoding and comprehension by:Being digitally supported in reading unfamiliar, relatively complex texts.Identifying and training relevant orthographic patterns before activating text‐to‐speech. [ABSTRACT FROM AUTHOR]

Evidence of self‐help interventions for adjustment disorder (AjD) is limited. This study aims at testing in a randomized controlled trial (RCT) the effectiveness of a disorder‐specific, Internet‐delivered cognitive–behavioural therapy (ICBT) intervention for AjD. Participants were randomly allocated to either an ICBT with brief weekly telephone support (n = 34) or a waiting list group (n = 34). Beck's inventories for depression and anxiety were used as primary outcomes. The secondary outcomes were AjD symptoms, post‐traumatic growth, positive and negative affect, and quality of life. In all, 76.5% of the participants completed the intervention. Compared with the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from 0.54 to 1.21) except in anxiety symptoms measured by Beck Anxiety Inventory (d = 0.27). Only ICBT group showed a significant improvement in post‐traumatic growth, positive and negative affect, and quality of life. The number of cases that achieved clinically meaningful change in all outcome measures was also higher in the ICBT group. All therapeutic gains were maintained at 3‐, 6‐ and 12‐month follow‐ups. The current study provides evidence on the effectiveness of ICBT interventions to reduce the impact of AjD. Results suggest that brief self‐help intervention with minimal therapist support is more effective than the mere passage of time in reducing the distress symptoms associated to the disorder and also can confer additional benefits. [ABSTRACT FROM AUTHOR]

Objectives: Adverse life events are associated with increased likelihood of depression and poorer prognosis. Trauma‐focused treatments (TFT) appear to be effective in decreasing comorbid depressive symptoms. Accordingly, the aim of this study was to evaluate the effectiveness of a TFT on the memories of aversive events for individuals with a primary diagnosis of depression. Methods: A randomized controlled trial was conducted with 49 participants recruited from a 10‐day outpatient group programme. All participants showed symptoms of depression with a subgroup (80%) meeting the DSM‐5 criteria for a major depressive episode. Participants received treatment as usual (TAU); three additional individual trauma‐focused sessions; or three additional individual assertiveness training sessions. Participants were assessed with regards to depression diagnosis and related symptoms. Results: For participants with a major depressive episode, the addition of trauma‐focused sessions significantly increased the likelihood of remission when compared to TAU, or additional assertiveness training. While no significant treatment difference was noted in depressive symptom change post‐treatment, six weeks after treatment those who received an adjunct treatment were more likely to maintain treatment gains than those who received TAU. Furthermore, at 12‐week follow‐up, participants who received a TFT reported significantly fewer depressive symptoms than those who received assertiveness training. Conclusions: While differences in outcomes were minimal immediately post‐treatment, differences among treatment groups increased over time. Thus, as few as three additional TFT sessions may impact positively on symptom change for people completing a group programme for the treatment of depression. Practitioner points: Depression is the greatest cause of disability worldwide.Adverse experiences are linked with an increased likelihood of depression, more severe symptoms and poor treatment outcomes following evidence‐based interventions.As few as three trauma‐focused sessions can improve treatment outcomes in terms of depression diagnosis and related symptoms for individuals receiving group cognitive behavioural therapy. [ABSTRACT FROM AUTHOR]

Background: Although a large number of adults with intellectual disabilities have depressive symptoms, non‐pharmacological treatments are scarce. The present authors investigated whether bright light therapy (BLT) is effective in decreasing depressive symptoms compared to care as usual. Methods: This multicentre randomized controlled trial consisted of three study groups (10,000 lux BLT, dim light BLT and a no‐BLT group). Participants received BLT for 30 min in the morning (14 consecutive days), additional to their regular care. Primary outcome was as follows: depressive symptoms measured with the ADAMS Depressive Mood subscale 1 week after the end of BLT (same time period in the no‐BLT group). Results: Forty‐one participants were included in our trial. In both BLT groups, a significant decrease in depressive symptoms was seen. No significant differences were found between 10,000 lux BLT and no‐BLT (p =.199) and no significant differences between dim light BLT and no‐BLT (p =.451). A minimum amount of side effects and no adverse events were reported. Conclusions: In both BLT interventions, a decrease in depressive symptoms was seen. With 10,000 lux BLT, depressive symptoms decreased even below the clinical cut‐off point, which makes BLT a promising intervention for clinical practice. [ABSTRACT FROM AUTHOR]

Background and aim: Reducing alcohol misuse by male prisoners is an important global issue. Control of drinking behaviour could be a useful target for intervention in this population, and locus of control could be a causal factor in this. We aimed to assess the effect of a clinical psychologist‐facilitated group intervention on male prisoners' locus of control of drinking behaviour. Design A two‐arm, single‐site, open, randomized controlled trial. Setting: A category B local training prison in South Wales, housing about 770 mainly sentenced men. Participants: Prisoners serving less than 2 years who met inclusion criteria for pre‐imprisonment alcohol misuse, alone or with drug misuse. A total of 119 were allocated to the intervention arm and 119 to the control arm; 104 and 87, respectively, completed the post‐randomization baseline interview and 68 and 60 completed a second interview approximately 4 weeks later, respectively, after intervention or treatment as usual (TAU) alone. Intervention: Nine clinical psychologist‐facilitated groups in the prison over 3 weeks. Range of participants per session was one to seven, with three to five most usual. Measures: The primary outcome was locus of control of behaviour (LCB); secondary outcomes included mental state generally (comprehensive psychiatric rating scale/CPRS) and specifically (Beck Depression Inventory/BDI). An integral process evaluation was conducted. Findings LCB scores decreased during the study, but without significant intervention effect [−1.7, 95% confidence interval (CI) = –5.1 to 1.6, P = 0.329]. Change among completers in the control group was from a mean score of 37.4 [standard deviation (SD) = 10.0] to 33.7[SD = 11.7] and in the intervention group from 37.4 (SD = 11.6) to 31.9 (SD = 11.8). Secondary outcomes, including change in mental state, did not differ between arms, but 686 (64%) sessions were lost, most because of 'prison issues'. Conclusions: A clinical psychologist‐facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre‐imprisonment alcohol misuse serving less than 2 years in a South Wales prison. The study proved coterminous, however, with 40% prison staff cuts which seem likely to have contributed to the high loss of group sessions and possibly overwhelmed any treatment effect. Intervention completion failures, previously cited as harmful, had no effect here, so the trial should be repeated when the prison climate improves. [ABSTRACT FROM AUTHOR]

Objective: Inpatient treatment for patients with anorexia nervosa (AN) is recommended in extreme or severe cases after failure of outpatient treatment and is highly effective. However, a number of patients show symptom increase and relapse after discharge. The aim of this study is to evaluate the efficacy of a therapist‐guided smartphone‐based aftercare intervention for inpatients with AN to support symptom stabilization. Method: A total of 186 female patients with a DSM‐5 diagnosis of AN (307.1) will be randomized either to receive a 16‐week smartphone‐based aftercare intervention with therapist feedback as add‐on to treatment as usual (TAU) or TAU alone. Data will be assessed at discharge (= baseline, T0), after 16 weeks (= end of the aftercare intervention, T1) and after 10 months (= 6‐month follow‐up, T2). Primary outcome will be overall eating disorder symptomatology (Eating Disorder Examination Global score). Secondary outcome measures will include body mass index, depression, motivation to change, self‐efficacy, patient satisfaction with and adherence to the smartphone‐based aftercare intervention as well as rehospitalization rate. Discussion: This study will be the first randomized controlled trial to examine a therapist‐guided smartphone‐based aftercare intervention for inpatients with AN. Results may reveal whether and to which extent this novel intervention can support symptom stabilization after inpatient treatment. [ABSTRACT FROM AUTHOR]

Objective: This study sought to investigate whether the immediate systemic inflammatory response following full‐mouth debridement differs following use of hand compared with ultrasonic instruments. Methods: Thirty‐nine periodontitis patients were randomized to treatment with full‐mouth debridement using either hand or ultrasonic instrumentation completed within 24 hr. Serum and periodontal clinical parameters were collected at baseline, day 1, day 7 and day 90 post‐treatment. Differences in systemic inflammatory markers were assessed using general linear models at each timepoint, corrected for age, gender, smoking status, body mass index and baseline levels of each marker. Results: Across all patients, serum C‐reactive protein increased at day 1, with no differences between hand and ultrasonic groups (p(adjusted) =.22). There was no difference between groups in interleukin‐6 (p(adjusted) =.29) or tumour necrosis factor α (p(adjusted) =.53) at day 1. Inflammatory markers returned to baseline levels by day 7. Treatment resulted in equal and marked improvements in clinical parameters in both groups; however, total treatment time was on average shorter for ultrasonic instruments (p(adjusted) =.002). Conclusions: Ultrasonic instrumentation resulted in shorter treatment time with comparable clinical outcomes. Levels of serum C‐reactive protein at day 1 were similar following debridement with hand or ultrasonic instruments. [ABSTRACT FROM AUTHOR]

Background: Deficits in social cognition are common in people with schizophrenia and are associated with impaired functioning. Finding effective interventions to address these deficits is a priority. Social Cognition Interaction Training (SCIT) is a psychosocial intervention that has demonstrated acceptability and feasibility in various health care settings. Larger, well‐designed randomized controlled trials are needed to examine the effectiveness of this intervention. Design: A randomized controlled trial. Methods: One hundred and twenty adults diagnosed with schizophrenia spectrum disorder were randomized to receive SCIT (n = 61) or Befriending Therapy (BT) (n = 59). Both intervention groups were delivered weekly for 2 hr over 12 weeks. Neurocognitive assessment was completed at baseline. Participants completed assessments of social cognition, social functioning, and meta‐cognition at baseline, post‐intervention, and 3‐month follow‐up. Results: There were no clinically significant differences between group outcomes on any measure of social cognition or social functioning. There was a trend for both groups to improve over time but not at a level of statistical significance. Conclusions: SCIT did not show any additional benefits on measures of social cognition compared to Befriending Therapy for people with schizophrenia spectrum disorder. The findings are discussed in terms of potential improvements to the programme. Practitioner points: Effective interventions for the social cognitive deficits of schizophrenia spectrum disorders are still being refined.Social Cognition Interaction Training is a promising therapy but requires further modifications to improve its effectiveness. [ABSTRACT FROM AUTHOR]

Background: A current recommendation for the treatment of patients with locoregionally advanced nasopharyngeal carcinoma (NPC) is conventional fractionated radiotherapy (RT) with concurrent cisplatin followed by adjuvant cisplatin and 5-fluorouracil (PF). This randomized NPC-0501 trial evaluated the therapeutic effect of changing to an induction-concurrent sequence or accelerated-fractionation sequence, and/or replacing 5-fluorouracil with capecitabine (X).Methods: Patients with American Joint Committee on Cancer/International Union Against Cancer stage III to stage IVB NPC initially were randomly allocated to 1 of 6 treatment arms (6-arm full-randomization cohort). The protocol was amended in 2009 to permit centers to opt out of randomization regarding fractionation (3-arm chemotherapy cohort).Results: A total of 803 patients were accrued (1 of whom was nonevaluable) from 2006 to 2012. Based on the overall comparisons, neither changing the chemotherapy sequence nor accelerated fractionation improved treatment outcome. However, secondary analyses demonstrated that when adjusted for RT parameters and other significant factors, the induction-concurrent sequence, especially the induction-PX regimen, achieved significant improvements in progression-free survival (PFS) and overall survival. Efficacy varied among different RT groups: although no impact was observed in the accelerated-fractionation group and the 3-arm chemotherapy cohort, a comparison of the induction-concurrent versus concurrent-adjuvant sequence in the conventional-fractionation group demonstrated a significant benefit in PFS (78% vs 62% at 5 years; P = .015) and a marginal benefit in overall survival (84% vs 72%; P = .042) after adjusting for multiple comparisons. Comparison of the induction-PX versus the adjuvant-PF regimen demonstrated better PFS (78% vs 62%; P = .027) without an increase in overall late toxicity.Conclusions: For patients irradiated using conventional fractionation, changing the chemotherapy sequence from a concurrent-adjuvant to an induction-concurrent sequence, particularly using induction cisplatin and capecitabine, potentially could improve efficacy without an adverse impact on late toxicity. However, further validation is needed for confirmation of these findings. [ABSTRACT FROM AUTHOR]

Objective: The current multicentre randomized controlled trial assessed the clinical efficacy of a combined mHealth intervention for eating disorders (EDs) based on cognitive behavioral therapy (CBT). Method: A total of 106 ED patients from eight different public and private mental health services in Spain were randomly assigned to two parallel groups. Patients of the experimental group (N = 53) received standard face‐to‐face CBT plus a mobile intervention through an application called "TCApp," which provides self‐monitoring and an online chat with the therapist. The control group (N = 53) received standard face‐to‐face CBT only. Patients completed self‐report questionnaires on ED symptomatology, anxiety, depression, and quality of life, before and after treatment. Results: Significant reductions in primary and secondary outcomes were observed for participants of both groups, with no differences between groups. Results also suggested that the frequency with which patients attended their referral mental health institution after the intervention was lower for patients in the experimental group than for those in the control group. Discussion The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face‐to‐face treatment. Besides, the additional component offered by the TCApp does not appear to be promising from a purely therapeutic perspective but perhaps as a cost‐effective tool, reducing thus the costs and time burden associated with weekly visits to health professionals. [ABSTRACT FROM AUTHOR]

Aims: Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx.Methods: A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years.Conclusion: The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx. [ABSTRACT FROM AUTHOR]

Aim: To test whether alerting clinicians to severe weight loss in older patients leads to higher dietitian visit rates, to higher body mass index (BMI) levels and, mainly, to lower annual death risk. Methods: The randomized controlled trial included patients aged ≥75 years, with BMI ≤23 kg/m2 that decreased ≥2 kg/m2 during the previous 2 years. All participants received usual care. Additionally, an email alert was sent only to clinicians of participants assigned to the email alert group. The follow‐up period was 12 months. Results: Among 706 participants (mean age 83 ± 6 years; mean baseline BMI 20.5 kg/m2), the BMI record was updated in 541 (77%) participants, and 123 participants died. Dietitian visits were reported for 22 patients (6%) in the email group (n = 362) and 14 patients (4%) in the control group (n = 344; OR 1.5, 95% CI 0.8–2.9; P = 0.24). Measured BMI were raised by a mean of 0.69 (95% CI 0.43–0.95) kg/m2 versus 0.79 (95% CI 0.48–1.1) kg/m2 (P = 0.63). A total of 77 patients (21%) died in the intervention group versus 47 (14%) in the control group (P = 0.008; number needed to harm = 13; 95% CI 7–43). Conclusions: In this trial, alerting clinical staff to severe weight loss in patients aged ≥75 years was not associated with higher visit rates to a dietitian or change in BMI, but was associated with a significantly higher death rate than usual clinical care. Geriatr Gerontol Int 2020; 20: 329–335. [ABSTRACT FROM AUTHOR]

Objective: Head‐to‐head randomized controlled trials (RCTs) are the gold standard for assessing comparative treatment effects. In the absence of direct comparisons between all possible antiepileptic drugs (AEDs), however, clinical decision‐making in focal (partial onset) epilepsy relies on alternative evidence borne from indirect comparisons including network meta‐analyses (NMAs) and from real‐world evidence (RWE) studies. We review NMAs and observational RWE studies comparing AEDs in the adjunctive setting to compare the robustness of these methods and to formulate recommendations for future evidence development. Methods: A literature review identified NMAs and RWE studies comparing AEDs for the adjunctive treatment of focal seizures published between January 2008 and October 2018. NMAs were evaluated for robustness using a framework based on guidelines from the National Institute for Health and Care Excellence Decision Support Unit and the International Society for Pharmacoeconomics and Outcomes Research. RWE studies were evaluated using the GRACE checklist. Results: From a total of 1993 records, 11 NMAs and six RWE studies were eligible. Key limitations identified in the NMAs include nonsystematic selection of RCTs, unexplored heterogeneity between included RCTs in terms of study and patient characteristics, and selection of AEDs and AED doses or dosing strategies that are not reflective of clinical practice. The main limitations of RWE studies concern sample size, design, and analysis methods. Approximately 90% of comparisons between individual AEDs were nonsignificant in the NMAs. None of the RWE studies adjusted for baseline differences between comparator groups; therefore, they lack the validity to make comparative conclusions. Significance: Current NMAs and RWE studies provide only nominal comparative evidence for AED treatments in focal epilepsy, and should be used with caution for decision‐making due to their methodological limitations. To overcome these hurdles, adherence to methodological guidelines and concerted efforts to collect relevant outcome data in the real world are needed. [ABSTRACT FROM AUTHOR]

Introduction: Vitamin D deficiency is common in pregnancy, especially in obese women. Lifestyle intervention could potentially result in higher levels of vitamin D. We therefore aimed to study the effect of lifestyle intervention during pregnancy on serum levels of 25-hydroxyvitamin D (25(OH)D).Material and Methods: A total of 360 obese women were randomized before gestational age 14 weeks to lifestyle intervention (diet and exercise) or routine clinical follow up (controls). Clinical outcomes and levels of 25(OH)D were determined three times: At gestational age 12-15 weeks (baseline), gestational age 28-30 weeks and 6 months postpartum.Results: A total of 304 (84%) women completed the intervention study and 238 (66%) attended postpartum follow up. Vitamin D levels were similar in the two groups at baseline. At gestational age 28-30 weeks and 6 months postpartum, 25(OH)D levels were significantly higher in the intervention group than in controls (75.6 vs 66.8 nmol/L, P = 0.009) and (54.8 vs 43.1 nmol/L, P = 0.013), respectively. Concurrently, vitamin D deficiency (25-hydroxyvitamin D <50 nmol/L) was less frequent in the intervention group than in controls: 15 vs 25% (P = 0.038) at gestational age 28-30 and 45 vs 63% (P = 0.011) 6 months postpartum, respectively.Conclusions: Lifestyle intervention during pregnancy was associated with significantly increased vitamin D levels in late pregnancy and postpartum compared with controls. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the relative effectiveness of dialectical behavior therapy guided self‐help (DBT‐GSH) and DBT unguided self‐help (DBT‐USH) with an unguided self‐help control condition in the treatment of binge‐eating disorder (BED). Method: Seventy‐one participants who met diagnostic criteria for BED based on Eating Disorder Examination (EDE) interview were randomly assigned to DBT‐GSH, DBT‐USH or active control USH for 12 weeks. Assessments took place at baseline, 12 weeks and 3‐month follow‐up. Outcome measures included the EDE to assess binge frequency, the EDE‐Questionnaire (EDE‐Q), the Brief Symptom Inventory, and the Short Form 6D. Results: The overall completion rate was 65% at post‐treatment and 63% at 3‐month follow‐up. Intention to treat analyses showed that participants in all three conditions reported significant reductions in binge frequency with large effect sizes. A similar pattern emerged for secondary outcome variables including eating disorder psychopathology, general psychological distress, and health‐related quality of life. Discussion: Self‐help may be an effective way to disseminate DBT for BED. However, future research should evaluate DBT self‐help using a larger sample size, possibly in a multisite design. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether elective preterm delivery (ED) at 34 weeks is of postnatal benefit to infants with isolated gastroschisis compared with routine obstetric care (RC).Methods: Between May 2013 and September 2015, all women with a sonographic diagnosis of fetal gastroschisis referred to a single tertiary center, before 34 weeks' gestation, were invited to participate in this study. Eligible patients were randomized to ED (induction of labor at 34 weeks) or RC (spontaneous labor or delivery by 37-38 weeks, based on standard obstetric indications). The primary outcome measure was length of time on total parenteral nutrition (TPN). Secondary outcomes were time to closure of gastroschisis and length of stay in hospital. Outcome variables were compared using appropriate statistical methods. Analysis was based on intention-to-treat.Results: Twenty-five women were assessed for eligibility, of whom 21 (84%; 95% CI, 63.9-95.5%) agreed to participate in the study; of these, 10 were randomized to ED and 11 to RC. The trial was stopped at the first planned interim analysis due to patient safety concerns and for futility; thus, only 21 of the expected 86 patients (24.4%; 95% CI, 15.8-34.9%) were enrolled. Median gestational age at delivery was 34.3 (range, 34-36) weeks in the ED group and 36.7 (range, 27-38) weeks in the RC group. One patient in the ED group delivered at 36 weeks following unsuccessful induction at 34 weeks. Neonates of women who underwent ED, compared to those in the RC group, showed no difference in the median number of days on TPN (54 (range, 17-248) vs 21 (range, 9-465) days; P = 0.08), number of days to closure of gastroschisis (7 (range, 0-15) vs 5 (range, 0-8) days; P = 0.28) and length of stay in hospital (70.5 (range, 22-137) vs 31 (range, 19-186) days; P = 0.15). However, neonates in the ED group were significantly more likely to experience late-onset sepsis compared with those in the RC group (40% (95% CI, 12.2-73.8%) vs 0%; P = 0.03).Conclusion: This study demonstrates no benefit of ED of fetuses with gastroschisis when postnatal gastroschisis management is similar to that used in routine care. Rather, the data suggest that ED is detrimental to infants with gastroschisis. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Background: Fatigue is a common and disabling side effect of targeted therapies such as tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). The goal of the current study was to conduct a pilot randomized trial of the first cognitive behavioral intervention developed for fatigue due to targeted therapy.Methods: Patients with CML treated with a TKI who were reporting moderate to severe fatigue were recruited and randomized 2:1 to cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC) group. The outcomes were acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome). Participants were assessed before randomization and after treatment (ie, approximately 18 weeks later).Results: A total of 44 patients (mean age, 55 years; 48% female) were assigned to CBT-TTF (n = 29) or WLC (n = 15). The study participation rate was 59%. Among the patients assigned to CBT-TTF, 79% completed the intervention. Intent-to-treat analyses indicated that patients assigned to CBT-TTF demonstrated greater improvements in fatigue (d = 1.06; P < .001) and overall quality of life (d = 1.15; P = .005) than those assigned to WLC. More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016).Conclusions: CBT-TTF displays preliminary efficacy in improving fatigue and quality of life among fatigued patients with CML treated with TKIs. The findings suggest that a larger randomized study is warranted. [ABSTRACT FROM AUTHOR]