Brief Web-Based Intervention for Depression: Randomized Controlled Trial on Behavioral Activation.
Ontology highlight
ABSTRACT: Background
Web-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s).Objective
The aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlapping active control intervention and a nonactive control group.Methods
We assessed 104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t0) and 2 weeks (t1) and 4 weeks (t2) later. After the t0 assessment, participants were randomly allocated to one of three groups: (1) iBA (n=37), (2) active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU, n=35). The primary outcome was improvement in depressive symptoms, as measured using the Patient Health Questionnaire-9. Secondary parameters included changes in activity, dysfunctional attitudes, and quality of life.Results
While groups did not differ regarding the change in depression from t0 to t1 (?p2=.007, P=.746) or t0 to t2 (?p2=.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t0 to t2 in comparison to CAU (?p2=.053, P=.04) and a larger increase in activity from t0 to t1 than the pooled control groups (?p2=.060, P=.02). A change in depression from t0 to t2 was mediated by a change in activity from t0 to t1. At t1, 22% (6/27) of the participants in the iBA group and 12% (3/25) of the participants in the iMBI group indicated that they did not use the intervention.Conclusions
Although we did not find support for the short-term efficacy of the single-module iBA regarding depression, long-term effects are still conceivable, potentially initiated by changes in secondary outcomes. Future studies should use a longer intervention and follow-up interval.Trial registration
DKRS (#DRKS00011562).
SUBMITTER: Jelinek L
PROVIDER: S-EPMC7146239 | biostudies-literature | 2020 Mar
REPOSITORIES: biostudies-literature
Publications
Brief Web-Based Intervention for Depression: Randomized Controlled Trial on Behavioral Activation.
Jelinek Lena L Arlt Sönke S Moritz Steffen S Schröder Johanna J Westermann Stefan S Cludius Barbara B
Journal of medical Internet research 20200326 3
<h4>Background</h4>Web-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s).<h4>Objective</h4>The aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlappi ...[more]
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Project description:BackgroundPhysical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression.ObjectiveThe objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes.MethodsParticipants with elevated depressive symptoms were recruited from the community through various methods (eg, social media) and randomized to eMotion or a waiting list control group for 8 weeks. eMotion is an administratively supported weekly modular program that helps people use key behavior change techniques (eg, graded tasks, action planning, and self-monitoring) to re-engage in routine, pleasurable, and necessary activities, with a focus on physical activities. Feasibility data were collected that included the following: recruitment and trial retention rates; fidelity of intervention delivery, receipt, and enactment; and acceptability of the intervention and data collection procedures. Data were collected for the primary (depression) and secondary outcomes (eg, anxiety, physical activity, fidelity, and client satisfaction) at baseline and 2 months postrandomization using self-reported Web-based questionnaires and accelerometers. Delivery fidelity (logins, modules accessed, time spent) was tracked using Web usage statistics. Exploratory analyses were conducted on the primary and secondary outcomes.ResultsOf the 183 people who contacted the research team, 62 were recruited and randomized. The mean baseline score was 14.6 (SD 3.2) on the 8-item Patient Health Questionnaire depression scale (PHQ-8). Of those randomized, 52 participants provided accelerometer-recorded physical activity data at baseline that showed a median of 35.8 (interquartile range [IQR] 0.0-98.6) minutes of moderate-to-vigorous physical activity (MVPA) recorded in at least 10-minute bouts per week, with only 13% (7/52) people achieving guideline levels (150 minutes of MVPA per week). In total, 81% (50/62) of participants provided follow-up data for the primary outcome (PHQ-8), but only 39% (24/62) provided follow-up accelerometer data. Within the intervention group, the median number of logins, modules accessed, and total minutes spent on eMotion was 3 (IQR 2.0-8.0), 3 (IQR 2.0-5.0), and 41.3 (IQR 18.9-90.4), respectively. Acceptability was mixed. Exploratory data analysis showed that PHQ-8 levels were lower for the intervention group than for the control group at 2 months postrandomization (adjusted mean difference -3.6, 95% CI -6.1 to -1.1).ConclusionsIt was feasible to deliver eMotion in UK communities to inactive populations. eMotion has the potential to be effective and is ready for testing in a full-scale trial. Further work is needed to improve engagement with both the intervention and data collection procedures.Trial registrationClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa).
| S-EPMC6066639 | biostudies-literature
Project description:BACKGROUND:Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. OBJECTIVE:To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). METHODS:A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). RESULTS:In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention's likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. CONCLUSIONS:Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. TRIAL REGISTRATION:German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9).
| S-EPMC5244034 | biostudies-other
Project description:BackgroundDepression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence-based treatment is limited.ObjectiveThis study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence.MethodsIn an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web-based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed.ResultsOf the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post-treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, P<.001, and BDI-II: d=0.41, CI 0.11-0.70, P=.004). PP analysis partially supported this result, but showed a non-significant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI -0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: -67.23%, P<.001, CG: -82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07).ConclusionsThe Web-based intervention was effective in reducing depressive symptoms among adults with sickness absence. As this trial achieved a lower power than calculated, its results should be replicated in a larger sample. Further validation of health insurance records as an outcome measure for eHealth trials is needed.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 02446836; http://www.isrctn.com/ISRCTN02446836 (Archived by WebCite at http://www.webcitation.org/6jx4SObnw).
| S-EPMC5491897 | biostudies-literature
Project description:BackgroundMeta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem.ObjectiveThis study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications.MethodsA 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures.ResultsWe randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (-8.9 points vs -3.0 points; mean between-group difference=-5.95; 95% CI -9.53 to -2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009.ConclusionsAlthough our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL).
| S-EPMC6231848 | biostudies-literature
Project description:BackgroundBehavioral activation is an effective treatment for depression that is theorized to facilitate structured increases in enjoyable activities that increase opportunities for contact with positive reinforcement; to date, however, only few mechanistic studies focused on a standalone intervention.MethodInterventions using internet-based behavioral activation or psychoeducation were compared based on data from a randomized-controlled trial of 313 patients with major depressive disorder. Activation level and depression were measured fortnightly (baseline, Weeks 2, 4, 6, 8, 10), using the Patient Health Questionnaire-9 and the Behavioral Activation for Depression Scale-Short Form, respectively. Analysis was performed to determine if a change in activation level mediated treatment efficacy.ResultsLatent growth modeling showed that internet-based behavioral activation treatment significantly reduced depressive symptoms from baseline to the end of treatment (standardized coefficient = -.13, p = .017) by increasing the rate of growth in the activation level (mediated effect estimate = -.17, 95% CI [-.27, -.07]. Results from mixed effects and simplex models showed that it took 4 weeks before mediation occurred (i.e., a significant change in activation that led to a reduction in depressive symptoms).ConclusionActivation level likely mediated the therapeutic effect of behavioral activation on depression in our intervention. This finding may be of significant value to clinicians and depressed individuals who should anticipate a 4-week window before seeing a prominent change in activation level and a 6-week window before depressive symptomatology reduces. Future research must consolidate our findings on how behavioral activation works and when mediation occurs.
| S-EPMC9667235 | biostudies-literature
Project description:BackgroundPregnancy is strongly associated with increased risk for depression. Approximately 25% of pregnant women develop depression. Treatment for depression during pregnancy has several complexities: the use of psychiatric medications during pregnancy might result in developmental problems in the child and must be used with caution. Psychosocial interventions are effective, but they require specialized professionals. Low- and middle-income countries (LMIC) such as Brazil do not have enough mental health professionals needed to meet this demand. In this context, smartphone-based interventions show immense potential. We developed Motherly, a smartphone application (app) designed to treat maternal depression. We aim to test the efficacy of Motherly in addition to brief cognitive-behavioral therapies (CBT) to treat maternal depression.MethodsWe will conduct a 2-arm parallel-randomized controlled clinical trial in which 70 pregnant women aged between 16 and 40 years with depression will be randomized to intervention or active control. The intervention group will have access to Motherly, a smartphone app based on three concepts: psychoeducation, behavior monitoring, and gaming elements. Motherly is composed of a package of interventions composed of modules: mental health, sleep, nutrition, physical activity, social support, prenatal/postnatal support, and educational content. The main focus of Motherly is delivering behavioral activation (BA), a brief and structured psychological treatment. The app allows participants to schedule and engage in, and monitor activities according to a plan to avoid acting exclusively according to their mood. The active control group will have access to a simplified version of the app consisting of educational content about various aspects of pregnancy, maternal physical and mental health, and infant development (BA, activity scheduling, sleep hygiene, among other functionalities, will not be present in this version). Both groups will receive four sessions of brief CBT in 8 weeks. Participants will be evaluated by assessors blind to randomization and allocation status. Assessments will occur at baseline (T0), midpoint (T1, week 4-5), posttreatment (T2, week 8), and follow-up (T3, when the child is 2 months old). Maternal mental health (prenatal anxiety, psychological well-being, perceived stress, depression, depression severity, and sleep quality), quality of life, physical activity levels, and infant developmental milestones and social/emotional problems will be measured. Our primary outcome is the change in maternal prenatal depression from baseline to posttreatment (8 weeks).DiscussionThe potential of digital technology to deliver mental health interventions has been increasingly recognized worldwide. There is a growing literature on interventions using smartphone applications to promote mental health, both with or without the intermediation of a mental health professional. Our study adds to the literature by testing whether an app providing an intervention package, including CBT, psychoeducation, nutrition, physical activity, and social support, can promote maternal and child health and well-being. In particular, we aim to treat depression, for which the use of digital technologies is still scarce. Smartphone applications designed to treat maternal depression are especially relevant because of the potential to circumvent barriers that prevent pregnant women from accessing mental health care.Trial registrationClinicalTrials.gov NCT04495166 . Prospectively registered on July 29, 2020.
| S-EPMC7985923 | biostudies-literature
Project description:BACKGROUND:Depression and anxiety disorders are significant contributors to burden of disease in young people, highlighting the need to focus preventive efforts early in life. Despite substantial evidence for the role of parents in the prevention of adolescent depression and anxiety disorders, there remains a need for translation of this evidence into preventive parenting interventions. To address this gap, we developed a single-session, Web-based, tailored psychoeducation intervention that aims to improve parenting practices known to influence the development of adolescent depression and anxiety disorders. OBJECTIVE:The aim of this study was to evaluate the short-term effects of the intervention on parenting risk and protective factors and symptoms of depression and anxiety in adolescent participants. METHODS:We conducted a single-blind, parallel group, superiority randomized controlled trial comparing the intervention with a 3-month waitlist control. The intervention is fully automated and consists of two components: (1) completion of an online self-assessment of current parenting practices against evidence-based parenting recommendations for the prevention of adolescent depression and anxiety disorders and (2) an individually tailored feedback report highlighting each parent’s strengths and areas for improvement based on responses to the self-assessment. A community sample of 349 parents, together with 327 adolescents (aged 12-15 years), were randomized to either the intervention or waitlist control condition. Parents and adolescents completed online self-reported assessments of parenting and adolescent symptoms of depression and anxiety at baseline, 1-month (parent-report of parenting only), and 3-month follow-up. RESULTS:Compared with controls, intervention group parents showed significantly greater improvement in parenting risk and protective factors from baseline to 1-month and 3-month follow-up (F2,331.22=16.36, P<.001), with a small to medium effect size at 3-month follow-up (d=0.33). There were no significant effects of the intervention on adolescent-report of parenting or symptoms of depression or anxiety in the adolescents (all P>.05). CONCLUSIONS:Findings suggest that a single-session, individually tailored, Web-based parenting intervention can improve parenting factors that are known to influence the development of depression and anxiety in adolescents. However, our results do not support the effectiveness of the intervention in improving adolescent depression or anxiety symptoms in the short-term. Long-term studies are required to adequately assess the relationship between improving parenting factors and adolescent depression and anxiety outcomes. Nonetheless, this is a promising avenue for the translation of research into a low-cost, sustainable, universal prevention approach. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry: ACTRN12615000247572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000247572 (Archived by WebCite at http://www.webcitation.org/6v1ha19XG)
| S-EPMC5945988 | biostudies-literature
Project description:BackgroundDepression often remains undiagnosed or treated inadequately. Web-based interventions for depression may improve accessibility of treatment and reduce disease-related costs. This study aimed to examine the potential of the web-based cognitive behavioral intervention "deprexis" in reducing disease-related costs.MethodsParticipants with mild to moderate depressive symptoms were recruited and randomized to either a 12-week web-based intervention (deprexis) in addition to care as usual (intervention group) or care as usual (control group). Outcome measures were health-related resource use, use of medication and incapacity to work as well as relating direct health care costs. Outcomes were assessed on patients' self-report at baseline, three months and six months.ResultsA total of 1013 participants were randomized. In both groups total direct health care costs decreased during the study period, but changes from baseline did not significantly differ between study groups. Numeric differences between study groups existed in outpatient treatment costs. They could be attributed to differences in changes of costs for psychotherapeutic treatment from baseline. Whereas costs for psychotherapeutic treatment decreased in the intervention group, costs increased in the control group (- 16.8% (€80) vs. + 14.7% (€60)) (tdf = 685 = 2.57; p = 0.008).ConclusionThe study indicates the health economic potential of innovative e-mental-health programs. There is evidence to suggest that the use of deprexis over a period of 12 weeks leads to a decrease in outpatient treatment cost, especially in those related to different types of psychotherapeutic treatment.
| S-EPMC6734272 | biostudies-literature
Project description:BackgroundDepression is the most prevalent mental health condition in older adults. However, not all evidence-based treatments are easily accessible. Web-delivered cognitive behavioral therapy (wCBT) facilitated by laypersons is a viable treatment alternative.ObjectiveThis randomized controlled trial aims to evaluate the efficacy of a novel wCBT program, Empower@Home, supported by trained lay coaches, against a waitlist attention control. Empower@Home is among the very few existing wCBT programs specifically designed for older adults. The primary objective was to assess the efficacy of the intervention compared with attention control. The secondary objective was to evaluate the program's impact on secondary psychosocial outcomes and explore potential change mechanisms.MethodsOlder adults (N=70) were recruited via web-based research registries, social media advertisements, and community agency referrals and randomly assigned to either the intervention or control group in a 1:1 allocation ratio. The intervention group received access to Empower@Home, which included 9 web-delivered self-help lessons and weekly telephone coaching sessions by a trained layperson over 10 weeks. The control group received weekly friendly phone calls and depressive symptom monitoring. The primary clinical outcome was the severity of depressive symptoms assessed using the Patient Health Questionnaire-9. The secondary clinical outcomes included anxiety, anger, social isolation, insomnia, pain intensity, and quality of life. Linear mixed modeling was used to determine the treatment effects on depression, and 2-tailed t tests were used to assess within-group changes and between-group differences.ResultsMost participants in the intervention group completed all 9 sessions (31/35, 89%). The usability and acceptability ratings were excellent. The intervention group had a large within-group change in depressive symptoms (Cohen d=1.22; P<.001), whereas the attention control group experienced a medium change (Cohen d=0.57; P<.001). The between-group effect size was significant, favoring the intervention group over the control group (Cohen d=0.72; P<.001). In the linear mixed model, the group-by-time interaction was statistically significant (b=-0.68, 95% CI -1.00 to -0.35; P<.001). The treatment effects were mediated by improvements in cognitive behavioral therapy skills acquisition; behavioral activation; and satisfaction with the basic psychological needs of autonomy, competence, and relatedness. Furthermore, the intervention group showed significant within-group improvements in secondary psychosocial outcomes, including anxiety (P=.001), anger (P<.001), social isolation (P=.02), insomnia (P=.007), and pain (P=.03). By contrast, the control group did not experience significant changes in these outcome domains. However, the between-group differences in secondary outcomes were not statistically significant, owing to the small sample size.ConclusionsEmpower@Home, a wCBT program supported by lay coaches, was more efficacious in reducing depressive symptoms than friendly telephone calls and depression symptom monitoring. Future studies should examine the effectiveness of the intervention in community and practice settings using nonclinician staff already present in these real-world settings as coaches.Trial registrationClinicalTrials.gov NCT05593276; https://clinicaltrials.gov/ct2/show/NCT05593276.International registered report identifier (irrid)RR2-10.2196/44210.
| S-EPMC10949125 | biostudies-literature
Project description:BackgroundMid-to-late adolescence is a critical period for initiation of alcohol and drug problems, which can be reduced by targeted brief motivational interventions. Web-based brief interventions have advantages in terms of acceptability and accessibility and have shown significant reductions of substance use among college students. However, the evidence is sparse among adolescents with at-risk use of alcohol and other drugs.ObjectiveThis study evaluated the effectiveness of a targeted and fully automated Web-based brief motivational intervention with no face-to-face components on substance use among adolescents screened for at-risk substance use in four European countries.MethodsIn an open-access, purely Web-based randomized controlled trial, a convenience sample of adolescents aged 16-18 years from Sweden, Germany, Belgium, and the Czech Republic was recruited using online and offline methods and screened online for at-risk substance use using the CRAFFT (Car, Relax, Alone, Forget, Friends, Trouble) screening instrument. Participants were randomized to a single session brief motivational intervention group or an assessment-only control group but not blinded. Primary outcome was differences in past month drinking measured by a self-reported AUDIT-C-based index score for drinking frequency, quantity, and frequency of binge drinking with measures collected online at baseline and after 3 months. Secondary outcomes were the AUDIT-C-based separate drinking indicators, illegal drug use, and polydrug use. All outcome analyses were conducted with and without Expectation Maximization (EM) imputation of missing follow-up data.ResultsIn total, 2673 adolescents were screened and 1449 (54.2%) participants were randomized to the intervention or control group. After 3 months, 211 adolescents (14.5%) provided follow-up data. Compared to the control group, results from linear mixed models revealed significant reductions in self-reported past-month drinking in favor of the intervention group in both the non-imputed (P=.010) and the EM-imputed sample (P=.022). Secondary analyses revealed a significant effect on drinking frequency (P=.037) and frequency of binge drinking (P=.044) in the non-imputation-based analyses and drinking quantity (P=.021) when missing data were imputed. Analyses for illegal drug use and polydrug use revealed no significant differences between the study groups (Ps>.05).ConclusionsAlthough the study is limited by a large drop-out, significant between-group effects for alcohol use indicate that targeted brief motivational intervention in a fully automated Web-based format can be effective to reduce drinking and lessen existing substance use service barriers for at-risk drinking European adolescents.Trial registrationInternational Standard Randomized Controlled Trial Registry: ISRCTN95538913; http://www.isrctn.com/ISRCTN95538913 (Archived by WebCite at http://www.webcitation.org/6XkuUEwBx).
| S-EPMC4897296 | biostudies-literature