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Background: Face-to-face brief interventions for problem drinking are effective, but they have found limited implementation in routine care and the community. Internet-based interventions could overcome this treatment gap. We investigated effectiveness and moderators of treatment outcomes in internet-based interventions for adult problem drinking (iAIs)., Methods and Findings: Systematic searches were performed in medical and psychological databases to 31 December 2016. A one-stage individual patient data meta-analysis (IPDMA) was conducted with a linear mixed model complete-case approach, using baseline and first follow-up data. The primary outcome measure was mean weekly alcohol consumption in standard units (SUs, 10 grams of ethanol). Secondary outcome was treatment response (TR), defined as less than 14/21 SUs for women/men weekly. Putative participant, intervention, and study moderators were included. Robustness was verified in three sensitivity analyses: a two-stage IPDMA, a one-stage IPDMA using multiple imputation, and a missing-not-at-random (MNAR) analysis. We obtained baseline data for 14,198 adult participants (19 randomised controlled trials [RCTs], mean age 40.7 [SD = 13.2], 47.6% women). Their baseline mean weekly alcohol consumption was 38.1 SUs (SD = 26.9). Most were regular problem drinkers (80.1%, SUs 44.7, SD = 26.4) and 19.9% (SUs 11.9, SD = 4.1) were binge-only drinkers. About one third were heavy drinkers, meaning that women/men consumed, respectively, more than 35/50 SUs of alcohol at baseline (34.2%, SUs 65.9, SD = 27.1). Post-intervention data were available for 8,095 participants. Compared with controls, iAI participants showed a greater mean weekly decrease at follow-up of 5.02 SUs (95% CI -7.57 to -2.48, p < 0.001) and a higher rate of TR (odds ratio [OR] 2.20, 95% CI 1.63-2.95, p < 0.001, number needed to treat [NNT] = 4.15, 95% CI 3.06-6.62). Persons above age 55 showed higher TR than their younger counterparts (OR = 1.66, 95% CI 1.21-2.27, p = 0.002). Drinking profiles were not significantly associated with treatment outcomes. Human-supported interventions were superior to fully automated ones on both outcome measures (comparative reduction: -6.78 SUs, 95% CI -12.11 to -1.45, p = 0.013; TR: OR = 2.23, 95% CI 1.22-4.08, p = 0.009). Participants treated in iAIs based on personalised normative feedback (PNF) alone were significantly less likely to sustain low-risk drinking at follow-up than those in iAIs based on integrated therapeutic principles (OR = 0.52, 95% CI 0.29-0.93, p = 0.029). The use of waitlist control in RCTs was associated with significantly better treatment outcomes than the use of other types of control (comparative reduction: -9.27 SUs, 95% CI -13.97 to -4.57, p < 0.001; TR: OR = 3.74, 95% CI 2.13-6.53, p < 0.001). The overall quality of the RCTs was high; a major limitation included high study dropout (43%). Sensitivity analyses confirmed the robustness of our primary analyses., Conclusion: To our knowledge, this is the first IPDMA on internet-based interventions that has shown them to be effective in curbing various patterns of adult problem drinking in both community and healthcare settings. Waitlist control may be conducive to inflation of treatment outcomes., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: DE has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, and German health insurance companies (BARMER, Techniker Krankenkasse). He is also a stakeholder of the Institute for health training online (GET.ON), which aims to implement scientific findings related to digital health interventions into routine care. RH's company owns the IP of the web applications that their data came from, as a basis for their contribution to the overall data set. HDV is the scientific director of Vision2Health, a company with the goal to implement evidence-based eHealth interventions. HR received a fee for participating in a brainstorm session on ehealth and bipolar disorders/PTSD organized by Sandoz. The remaining authors declare no competing interests.

Background: Brief interventions for smoking cessation and alcohol moderation may contribute considerably to the prevention of cancer among populations at risk, such as cancer survivors, in addition to improving their general wellbeing. There is accumulating evidence for the effectiveness of internet-based brief health behaviour interventions. The objective of this study is to assess the effectiveness, patient-level cost-effectiveness and cost-utility of two new online theory-based self-help interventions among adult cancer survivors in the Netherlands. One of the interventions focuses on alcohol moderation, the other on smoking cessation. Both interventions are tailored to cancer survivors., Methods: Effectiveness will be assessed in two separate, nearly identical 2-armed RCTs: alcohol moderation (AM RCT) and smoking cessation (SC RCT). Participants are randomly allocated to either the intervention groups or the control groups. In the intervention groups, participants have access to one of the newly developed interventions. In the control groups, participants receive an online static information brochure on alcohol (AM RCT) or smoking (SC RCT). Main study outcome parameters are the number of drinks post-randomisation (AM RCT) and tobacco abstinence (SC RCT). In addition, cost-data and possible effect moderators and mediators will be assessed. Both treatments are internet-based minimally guided self-help interventions: MyCourse - Moderate Drinking (in Dutch: MijnKoers - Minderen met Drinken) and MyCourse - Quit Smoking (MijnKoers - Stoppen met Roken). They are based on cognitive behaviour therapy (CBT), motivational interviewing (MI) and acceptance and commitment therapy (ACT). Both interventions are optimized in collaboration with the target population of cancer survivors in focus groups and interviews, and in collaboration with several experts on eHealth, smoking cessation, alcohol misuse and cancer survivorship., Discussion: The present study will add to scientific knowledge on the (cost-)effectiveness of internet-based self-help interventions to aid in smoking cessation or alcohol moderation, working mechanisms and impact on quality of life of cancer survivors. If found effective, these interventions can contribute to providing evidence-based psychosocial oncology care to a growing population of cancer survivors., Trial Registration: Trials are prospectively registered in The Netherlands Trial Register (NTR): NTR6011 (SC RCT), NTR6010 (AM RCT) on 1 September 2016.

Background: Psychiatric patients are at high risk of becoming victim of a violent crime compared to the general population. Although most research has focused on patients with severe mental illness, depressed patients have been demonstrated to be prone to victimization as well. Victimization is associated with more severe symptomatology, decreased quality of life, and high risk of revictimization. Hence, there is a strong need for interventions that focus on preventing violent revictimization. Since emotion dysregulation is associated with both victimization and depression, we developed an internet-based Emotion Regulation Training (iERT) to reduce revictimization in depressed patients. This study aims to evaluate the clinical and cost-effectiveness of iERT added to Treatment As Usual (TAU) in reducing incidents of violent revictimization among depressed patients with a recent history of victimization. Furthermore, this study aims to examine secondary clinical outcomes, and moderators and mediators that may be associated with treatment outcomes., Methods: In a multicenter randomized controlled trial with parallel group design, patients with a major depressive disorder and a history of violent victimization over the past three years (N = 200) will be allocated to either TAU + iERT (N = 100) or TAU only (N = 100), based on computer-generated stratified block randomization. Assessments will take place at baseline, 8 weeks, 14 weeks, and 6 months after start of treatment, and 12, 24, and 36 months after baseline. The primary outcome measure is the total number of violent victimization incidents at 12 months after baseline, measured with the Safety Monitor: an adequate self-report questionnaire that assesses victimization over the preceding 12 months. Secondary outcome measures and mediators include emotion dysregulation and depressive symptomatology. An economic evaluation with the societal perspective will be performed alongside the trial., Discussion: This study is the first to examine the effectiveness of an intervention aimed at reducing violent revictimization in depressed patients. If effective, iERT can be implemented in mental health care, and contribute to the well-being of depressed patients. Furthermore, the results will provide insight into underlying mechanisms of revictimization., Trial Registration: The study is registered at the Netherlands Trial Register ( NTR5822 ). Date of registration: 4 April 2016.

Background: The Internet has increasingly been studied as mode of delivery for interventions targeting problematic alcohol use. Most interventions have been fully automated, but some research suggests that adding counselor guidance may improve alcohol consumption outcomes., Methods: An eight-module Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help-seekers. Eighty participants with problematic alcohol use according to the Alcohol Use Disorders Identification Test (AUDIT; scores of ≥ 6 for women and ≥ 8 for men) were recruited online from an open access website and randomized into three different groups. All groups were offered the same self-help program, but participants in two of the three groups received Internet-based counselor guidance in addition to the self-help program. One of the guidance groups was given a choice between guidance via asynchronous text messages or synchronous text-based chat, while the other guidance group received counselor guidance via asynchronous text messages only., Results: In the choice group, 65% (13 of 20 participants) chose guidance via asynchronous text messages. At the 10-week post-treatment follow-up, an intention-to-treat (ITT) analysis showed that participants in the two guidance groups (choice and messages) reported significantly lower past week alcohol consumption compared to the group without guidance; 10.8 (SD = 12.1) versus 22.6 (SD = 18.4); p = 0.001; Cohen's d = 0.77. Participants in both guidance groups reported significantly lower scores on the AUDIT at follow-up compared to the group without guidance, with a mean score of 14.4 (SD = 5.2) versus 18.2 (SD = 5.9); p = 0.003; Cohen's d = 0.68. A higher proportion of participants in the guidance groups said that they would recommend the program compared to the group without guidance (81% for choice; 93% for messages versus 47% for self-help)., Conclusion: Self-help programs for problematic alcohol use can be more effective in reducing alcohol consumption over a 10-week period when counselor guidance is added., Trial Registration: Clinicaltrials.gov NCT02384304.

Introduction: In the general population, alcohol use disorder and depression more often occur together than any other combination of a mental illness with a substance use disorder. It is important to have a cost-effective intervention that is able to reach at-risk individuals in the early stages of developing alcohol use disorders and depression disorders., Methods and Analysis: This paper presents the protocol for a 3-arm multicentre randomised controlled trial (RCT) to test the efficacy and cost-effectiveness of the combined internet-based self-help intervention Take Care of You (TCOY) to reduce alcohol misuse and depression symptoms in comparison with a waiting list control group and a comparable intervention focusing on problematic alcohol use only. The active interventions consist of modules designed to reduce alcohol use, based on the principles of motivational interviewing and methods of cognitive behavioural therapy, together with additional modules in the combined study arm to reduce symptoms of depression. Data will be collected at baseline, as well as at 3 and 6 months postrandomisation. The primary outcome is the quantity of alcohol used in the past 7 days. A number of secondary outcome measures will be studied. These include the Centre of Epidemiologic Studies of Depression Scale (CES-D) and a combined measure with the criteria of values below the cut-off for severe alcohol use disorder and for CES-D. Data analysis will follow the intention-to-treat principle using (generalised) linear mixed models. In order to investigate the interventions' cost-utility and cost-effectiveness, a full economic evaluation will be performed., Ethics and Dissemination: This RCT will be executed in compliance with the Helsinki Declaration and has been approved by 2 local Ethics Committees. Results will be reported at conferences and in peer-reviewed publications. Participant-friendly summaries of trial findings will be published on the TCOY websites., Trial Registration Number: ISRCTN10323951., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Alcohol misuse ranks within the top ten health conditions with the highest global burden of disease. Low-intensity, Internet interventions for curbing adult alcohol misuse have been shown effective. Few meta-analyses have been carried out, however, and they have involved small numbers of studies, lacked indicators of drinking within low risk guidelines, and examined the effectiveness of unguided self-help only. We therefore conducted a more thorough meta-analysis that included both guided and unguided interventions., Methods: Systematic literature searches were performed up to September 2013. Primary outcome was the mean level of alcohol consumption and drinking within low risk guidelines for alcohol consumption at post-treatment., Findings: We selected 16 randomised controlled trials (with 23 comparisons and 5,612 participants) for inclusion. Results, showed a small but significant overall effect size in favour of Internet interventions (g = 0.20, 95% CI: 0.13-0.27, p<.001). Participants in Internet interventions drunk on average 22 grams of ethanol less than controls and were significantly more likely to be adhering to low-risk drinking guidelines at post-treatment (RD 0.13, 95% CI: 0.09-0.17, p<.001). Subgroup analyses revealed no significant differences in potential moderators for the outcome of alcohol consumption, although there was a near-significant difference between comparisons with waitlist control and those with assessment-only or alcohol information control conditions (p = .056)., Conclusions: Internet interventions are effective in reducing adult alcohol consumption and inducing alcohol users to adhere to guidelines for low-risk drinking. This effect is small but from a public health point of view this may warrant large scale implementation at low cost of Internet interventions for adult alcohol misuse. Moderator analyses with sufficient power are, however, needed in order to assess the robustness of these overall results and to assess whether these interventions may impact on subgroups with different levels of success.

Background: Internet interventions with and without therapist support have been found to be effective treatment options for harmful alcohol users. Internet-based therapy (IT) leads to larger and longer-lasting positive effects than Internet-based self-help (IS), but it is also more costly to provide., Objective: To evaluate the cost effectiveness and cost utility of Internet-based interventions for harmful use of alcohol through the assessment of the incremental cost effectiveness of IT compared with IS., Methods: This study was performed in a substance abuse treatment center in Amsterdam, the Netherlands. We collected data over the years 2008-2009. A total of 136 participants were included, 70 (51%) were female, and mean age was 41.5 (SD 9.83) years. Reported alcohol consumption and Alcohol Use Disorders Identification Test (AUDIT) scores indicated harmful drinking behavior at baseline. We collected self-reported outcome data prospectively at baseline and 6 months after randomization. Cost data were extracted from the treatment center's cost records, and sex- and age-specific mean productivity cost data for the Netherlands., Results: The median incremental cost-effectiveness ratio was estimated at €3683 per additional treatment responder and €14,710 per quality-adjusted life-year (QALY) gained. At a willingness to pay €20,000 for 1 additional QALY, IT had a 60% likelihood of being more cost effective than IS. Sensitivity analyses attested to the robustness of the findings., Conclusions: IT offers better value for money than IS and might therefore be considered as a treatment option, either as first-line treatment in a matched-care approach or as a second-line treatment in the context of a stepped-care approach., Trial Registration: Netherlands Trial Register NTR-TC1155; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1155 (Archived by WebCite at http://www.webcitation.org/6AqnV4eTU).

Background: Informing policy decisions about the cost-effectiveness of health care systems (ie, packages of clinical interventions) is probably best done using a modeling approach. To this end, an alcohol model (ALCMOD) was developed., Objective: The aim of ALCMOD is to estimate the cost-effectiveness of competing health care systems in curbing alcohol use at the national level. This is illustrated for scenarios where new eHealth technologies for alcohol use disorders are introduced in the Dutch health care system., Method: ALCMOD assesses short-term (12-month) incremental cost-effectiveness in terms of reductions in disease burden, that is, disability adjusted life years (DALYs) and health care budget impacts., Results: Introduction of new eHealth technologies would substantially increase the cost-effectiveness of the Dutch health care system for alcohol use disorders: every euro spent under the current system returns a value of about the same size (€1.08, ie, a "surplus" of 8 euro cents) while the new health care system offers much better returns on investment, that is, every euro spent generates €1.62 in health-related value., Conclusion: Based on the best available evidence, ALCMOD's computations suggest that implementation of new eHealth technologies would make the Dutch health care system more cost-effective. This type of information may help (1) to identify opportunities for system innovation, (2) to set agendas for further research, and (3) to inform policy decisions about resource allocation.

Background: Only a minority of all alcohol- and drug abusers is receiving professional care. In an attempt to narrow this treatment gap, treatment facilities experiment with online healthcare. Therefore, it is important to test the (cost-)effectiveness of online health interventions in a randomized clinical trial., Methods: This paper presents the protocol of a three-arm randomized clinical trial to test the (cost-) effectiveness of online treatment for problem drinkers. Self-help online, therapy online and a waiting list are tested against each other. Primary outcome is change in alcohol consumption. Secondary outcome measures include quality of life and working ability. Incremental cost-effectiveness ratios for self-help online alcohol and therapy online alcohol will be calculated. The predictive validity of participant characteristics on treatment adherence and outcome will be explored., Discussion: To our best knowledge, this randomized clinical trial will be the first to test the effectiveness of therapy online against both self-help online and a waiting-list. It will provide evidence on (cost-) effectiveness of online treatment for problem drinkers and investigate outcome predictors., Trial Registration: This trial is registered in the Dutch Trialregister (Cochrane Collaboration) and traceable as NTR-TC1155.

Background: Heavy cannabis use is associated with adverse physical and mental health effects. Despite available effective treatments, the majority of heavy cannabis users does not seek professional help. Web-based interventions can provide an alternative for cannabis users who are reluctant to seek professional help. Several web-based cannabis interventions are effective in reducing cannabis use; however, the effect sizes are typically small and attrition rates are typically high. This suggests that web-based programs can be an effective cannabis use intervention for some, while others may need additional substance use treatment after completing a web-based intervention. Therefore, it is important that web-based interventions do not solely focus on reducing cannabis use, but also on improving attitudes towards substance use treatment. The Screening Brief Intervention and Referral to Treatment (SBIRT) approach appears to be well suited for the purpose of reducing cannabis use and improving substance use treatment utilization. Based on the SBIRT approach-and based on cognitive behavioral therapy (CBT) and motivational interviewing (MI)-we developed the Internet-based cannabis reduction intervention ICan.Methods/design: This protocol paper presents the design of a randomized controlled trial (RCT) in which we evaluate the effectiveness of the ICan intervention compared to four online modules of educational information on cannabis in a sample of Dutch frequent cannabis users. The primary outcome measure is frequency of cannabis use. Secondary outcome measures include the quantity of cannabis used (grams), the attitudes towards seeking help and the number of participants who enter specialized treatment services for cannabis use-related problems.Discussion: To the best of our knowledge, ICan is the first Internet-based intervention for cannabis users that combines screening, a brief intervention-based on CBT and MI-and referral to treatment options.Trial Registration: The study is registered in the Netherlands Trial Register; identifier NL7668 . Registered on 17 April 2019. [ABSTRACT FROM AUTHOR]

Background: Internet-based interventions are seen as attractive for harmful users of alcohol and lead to desirable clinical outcomes. Some participants will however not achieve the desired results. In this study, harmful users of alcohol have been partitioned in subgroups with low, intermediate or high probability of positive treatment outcome, using recursive partitioning classification tree analysis. Methods: Data were obtained from a randomized controlled trial assessing the effectiveness of two Internet-based alcohol interventions. The main outcome variable was treatment response, a dichotomous outcome measure for treatment success. Candidate predictors for the classification analysis were first selected using univariate regression. Next, a tree decision model to classify participants in categories with a low, medium and high probability of treatment response was constructed using recursive partitioning software. Results: Based on literature review, 46 potentially relevant baseline predictors were identified. Five variables were selected using univariate regression as candidate predictors for the classification analysis. Two variables were found most relevant for classification and selected for the decision tree model: 'living alone', and 'interpersonal sensitivity'. Using sensitivity analysis, the robustness of the decision tree model was supported. Conclusions: Harmful alcohol users in a shared living situation, with high interpersonal sensitivity, have a significantly higher probability of positive treatment outcome. The resulting decision tree model may be used as part of a decision support system but is on its own insufficient as a screening algorithm with satisfactory clinical utility. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depressive disorders are prevalent in adolescents and young adults. However, most young people with mental health problems do not receive treatment. Computerized cognitive behavior therapy (cCBT) may provide an accessible alternative to face-to-face treatment, but the evidence base in young people is limited.Objective: The objective was to perform an up-to-date comprehensive systematic review and meta-analysis of the effectiveness of cCBT in treating anxiety and depression in adolescents and young adults compared with active treatment and passive controls. We aimed to examine posttreatment and follow-up effects and explore the moderators of treatment effects.Methods: We conducted systematic searches in the following six electronic databases: PubMed, EMBASE, PsycINFO, CINAHL, Web of Science, and Cochrane Central Register of Controlled Trials. We included randomized controlled trials comparing cCBT with any control group in adolescents or young adults (age 12-25 years) with anxiety or depressive symptoms. The quality of included studies was assessed using the Cochrane risk-of-bias tool for randomized trials, version 2.0. Overall quality of evidence for each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Posttreatment means and SDs were compared between intervention and control groups, and pooled effect sizes (Hedges g) were calculated. Random-effects meta-analyses were conducted using Comprehensive Meta-Analysis software. Subgroup analyses and meta-regression analyses were conducted to explore whether age, guidance level, and adherence rate were associated with treatment outcome.Results: The search identified 7670 papers, of which 24 studies met the inclusion criteria. Most included studies (22/24) had a high risk of bias owing to self-report measures and/or inappropriate handling of missing data. Compared with passive controls, cCBT yielded small to medium posttreatment pooled effect sizes regarding depressive symptoms (g=0.51, 95% CI 0.30-0.72, number needed to treat [NNT]=3.55) and anxiety symptoms (g=0.44, 95% CI 0.23-0.65, NNT=4.10). cCBT yielded effects similar to those of active treatment controls regarding anxiety symptoms (g=0.04, 95% CI -0.23 to 0.31). For depressive symptoms, the nonsignificant pooled effect size favored active treatment controls (g=-0.70, 95% CI -1.51 to 0.11, P=.09), but heterogeneity was very high (I2=90.63%). No moderators of treatment effects were identified. At long-term follow-up, cCBT yielded a small pooled effect size regarding depressive symptoms compared with passive controls (g=0.27, 95% CI 0.09-0.45, NNT=6.58). No other follow-up effects were found; however, power was limited owing to the small number of studies.Conclusions: cCBT is beneficial for reducing posttreatment anxiety and depressive symptoms in adolescents and young adults compared with passive controls. Compared with active treatment controls, cCBT yielded similar effects regarding anxiety symptoms. Regarding depressive symptoms, however, the results remain unclear. More high-quality research involving active controls and long-term follow-up assessments is needed in this population.Trial Registration: PROSPERO CRD42019119725; https://tinyurl.com/y5acfgd9. [ABSTRACT FROM AUTHOR]

Background: Missing data is a common nuisance in eHealth research: it is hard to prevent and may invalidate research findings.Objective: In this paper several statistical approaches to data "missingness" are discussed and tested in a simulation study. Basic approaches (complete case analysis, mean imputation, and last observation carried forward) and advanced methods (expectation maximization, regression imputation, and multiple imputation) are included in this analysis, and strengths and weaknesses are discussed.Methods: The dataset used for the simulation was obtained from a prospective cohort study following participants in an online self-help program for problem drinkers. It contained 124 nonnormally distributed endpoints, that is, daily alcohol consumption counts of the study respondents. Missingness at random (MAR) was induced in a selected variable for 50% of the cases. Validity, reliability, and coverage of the estimates obtained using the different imputation methods were calculated by performing a bootstrapping simulation study.Results: In the performed simulation study, the use of multiple imputation techniques led to accurate results. Differences were found between the 4 tested multiple imputation programs: NORM, MICE, Amelia II, and SPSS MI. Among the tested approaches, Amelia II outperformed the others, led to the smallest deviation from the reference value (Cohen's d = 0.06), and had the largest coverage percentage of the reference confidence interval (96%).Conclusions: The use of multiple imputation improves the validity of the results when analyzing datasets with missing observations. Some of the often-used approaches (LOCF, complete cases analysis) did not perform well, and, hence, we recommend not using these. Accumulating support for the analysis of multiple imputed datasets is seen in more recent versions of some of the widely used statistical software programs making the use of multiple imputation more readily available to less mathematically inclined researchers. [ABSTRACT FROM AUTHOR]