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

Objectives: To determine the effectiveness of advance care planning (ACP) in frail older adults. Design: Cluster randomized controlled trial. Setting: Residential care homes in the Netherlands (N=16). Participants: Care home residents and community‐dwelling adults receiving home care (N=201; n=101 intervention; n=100 control). Participants were 75 years and older, frail, and capable of consenting to participation. Intervention: Adjusted Respecting Choices ACP program. Measurements: The primary outcome was change in patient activation (Patient Activation Measure, PAM‐13) between baseline and 12‐month follow‐up. Secondary outcomes included change in quality of life (SF‐12), advance directive (AD) completion, and surrogate decision‐maker appointment. Use of medical care in the 12 months after inclusion was also assessed. Multilevel analyses were performed, controlling for clustering effects and differences in demographics. Results: Seventy‐seven intervention participants and 83 controls completed the follow‐up assessment. There were no statistically significant differences between the intervention (–0.26±11.2) and control group (–1.43±10.6) in change scores of the PAM (p=.43) or the SF‐12. Of intervention group participants, 93% completed an AD, and 94% appointed a decision‐maker. Of control participants, 34% completed an AD, and 67% appointed a decision‐maker (p<.001). No differences in the use of medical care were found. Conclusions: ACP did not increase levels of patient activation or quality of life but did increase completion of ADs and appointment of surrogate decision‐makers. It did not affect use of medical care. [ABSTRACT FROM AUTHOR]

Objectives To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (pre DIVA) trial-over 6 years. Design Secondary analysis. Setting One hundred sixteen general practices in the Netherlands. Participants Community-dwelling individuals aged 70 to 78 (N = 2,994). Intervention Nurse-led multidomain intervention targeting cardiovascular risk factors to prevent dementia. Measurements The associations between participant baseline sociodemographic (age, sex, education), clinical (medical history, disability, cardiovascular risk), neuropsychiatric (depressive symptoms (Geriatric Depression Scale-15), and cognitive (Mini-Mental State Examination)) characteristics and dropout from the trial and nonadherence to the trial intervention were explored using multilevel logistic regression models. Results Older age, poorer cognitive function, more symptoms of depression, and greater disability were the most important determinants of dropout of older people. The presence of cardiovascular risk factors was not associated with dropout but was associated with nonadherence. Being overweight was a risk factor for nonadherence, whereas people with high blood pressure or a low level of physical exercise adhered better to the intervention. The association between poorer cognitive function and symptoms of depression and dropout was stronger in the control group than in the intervention group, and vice versa for increased disability. Conclusion In a large dementia prevention trial with 6-year follow-up, dropout was associated with older age, poorer cognitive function, symptoms of depression, and disability at baseline. These findings can help to guide the design of future dementia prevention trials in older adults. The associations found between cardiovascular risk factors and nonadherence need to be confirmed in other older populations receiving cardiovascular prevention interventions. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective To investigate the cost-utility of the internet-based intervention 'Featback' provided with different levels of therapist support, in comparison to a waiting list. Method This economic evaluation was conducted from a societal perspective and was part of a randomized controlled trial in which participants ( N = 354) with self-reported ED symptoms were randomized to: (1) 8 weeks of Featback, consisting of psychoeducation and a fully automated monitoring- and feedback system, (2) Featback with low-intensity (weekly) therapist support, (3) Featback with high-intensity (three times a week) therapist support, and (4) a waiting list. Participants were assessed at baseline, postintervention, and 3-month follow-up. Cost-utility acceptability curves were constructed. Results No significant differences between the study conditions were found regarding quality-adjusted life-years ( P = 0.55) and societal costs ( P = 0.45), although the mean costs per participant were lowest in the Featback condition with low-intensity therapist support (€1951), followed by Featback with high-intensity therapist support (€2032), Featback without therapist support (€2102), and the waiting list (€2582). Featback seemed to be cost-effective as compared to the waiting list. No clear preference was found for Featback with or without therapist support. Discussion A fully automated Internet-based intervention for ED symptoms with no, low-, or high-intensity therapist support represented good value for money when compared to a waiting list. This finding may have important implications for clinical practice, as both the unguided- and guided intervention could allow for more efficient care and widespread dissemination, potentially increasing the accessibility and availability of mental health care services for individuals with ED symptoms. © 2016 Wiley Periodicals, Inc. (Int J Eat Disord 2016; 49:1068-1076) [ABSTRACT FROM AUTHOR]

Objectives To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Design Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Setting Primary care setting, 39 general practices in the Netherlands. Participants Community-dwelling people aged 60 and older (N = 3,092). Interventions A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. Measurements Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living ( ADLs), 8 instrumental activities of daily living ( IADLs), one mobility item (range 0-15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. Results The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval ( CI) = 1.77-1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80-1.96; control group, 2.03, 95% CI = 1.92-2.13; P = .03). No differences in quality of life were observed. Conclusion Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results. [ABSTRACT FROM AUTHOR]

ABSTRACT BACKGROUND Preventing overweight and improving physical fitness in primary school children is a worldwide challenge, and physically active intervention programs usually come with the cost of academic instruction time. This study aimed to investigate effects of physically active academic lessons on body mass index ( BMI) and physical fitness in primary school children. METHODS Dutch children attending second- or third-grade class from 12 primary schools (N = 376; 8.1 ± 0.7 years) were randomly assigned to a 22-week intervention program or to the control group. In addition to measuring BMI before and after the intervention, physical fitness was measured with 5 items of the Eurofit test battery, measuring cardiovascular and muscular fitness. RESULTS Multilevel analysis showed a significant interaction effect between condition (intervention vs control) and grade (B = −0.47; p < .05). For third-grade children, BMI of the intervention group did not change significantly during the intervention period, whereas a significant increase was found in the control group. No significant main or interaction effects were found for cardiovascular or muscular fitness. CONCLUSIONS The current physically active academic lessons had positive effects on BMI in third-grade children, but had no effects on cardiovascular and muscular fitness. [ABSTRACT FROM AUTHOR]

Aim To assess whether outcome of immediate implant placement and immediate provisionalization after 1 year was non-inferior to immediate implant placement and delayed provisionalization regarding Marginal Bone Level (MBL). Materials and Methods Forty patients with a failing tooth in the aesthetic zone were randomly assigned for immediate implant placement with immediate ( n = 20) or delayed ( n = 20) provisionalization. Follow-up was at 1 month and after 1 year. The study was powered to detect a difference in MBL of <0.9 mm. Apart from MBL, soft tissue peri-implant parameters, aesthetic indexes and patient satisfaction were assessed. Results After 1 year, MBL changes were −0.75 ± 0.69 mesially and −0.68 ± 0.65 distally mm for the immediate group and −0.70 ± 0.64 and −0.68 ± 0.64 mm for the delayed group respectively ( NS). Regarding differences in means, non-inferiority was observed after 1 year (mesially: Group A versus B: difference in mean 0.08 mm (95% CI −0.38 to 0.53, p = 0.71 distally: Group A versus B: difference in mean 0.09 mm (95% CI −0.37 to 0.56 mm, p = 0.66).No significant differences in the other outcome variables were observed. Conclusions This study showed that immediate placement and immediate provisionalization was non-inferior to immediate placement with delayed provisionalization. In addition, although not powered for these outcome variables, no clinically relevant differences in other outcomes were observed (: ISRCTN57251089). [ABSTRACT FROM AUTHOR]

Background: Until now, working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD; for young children with ADHD, no studies are available. To this end, a triple-blind, randomized, placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training (CWMT) in young children with ADHD. Methods: Fifty-one children (5-7 years) with a DSM-IV-TR diagnosis of ADHD (without current psychotropic medication) were randomly assigned to the active (adaptive) or placebo (nonadaptive) training condition for 25 sessions during 5 weeks. The compliance criterion (>20 sessions) was met for 47 children. The primary outcome measure concerned the core behavioural symptoms of ADHD, measured with the ADHD Rating Scale IV (ADHD-RS). Secondary outcome measures were neurocognitive functioning, daily executive functioning, and global clinical functioning. The influence of the increase in difficulty level (Index-Improvement) for the treatment group was also analysed. Clinical trial registration information - 'Working Memory Training in Young ADHD Children'; www.clinicaltrials.gov; NCT00819611. Results: A significant improvement in favour of the active condition was found on a verbal working memory task (p = .041; adapted Digit Span WISC-III, backward condition). However, it did not survive correction for multiple testing. No significant treatment effect on any of the primary or other secondary outcome measurements was found. The Index-Improvement significantly contributed to ADHD-RS and the Behavior Rating Inventory of Executive Function, both rated by the teacher, but revealed no significant group difference. Conclusions: This study failed to find robust evidence for benefits of CMWT over the placebo training on behavioural symptoms, neurocognitive, daily executive, and global clinical functioning in young children with ADHD. [ABSTRACT FROM AUTHOR]