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Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial.

ABSTRACT: BACKGROUND:Despite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000's, most of the country's alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level. METHODS:A two-arm randomized controlled trial (RCT) has been designed to compare the efficacy of a culturally-adapted minimal-guidance online self-help program, the 8-week "Selge" online program against a control condition that consists of a self-administered test of alcohol use and advice regarding usual treatment in Estonia. A target sample of 600 individuals will be recruited and randomly assigned to either condition. The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI). Participants in the control group will have access to the full treatment after they complete their final follow-up assessment. The primary outcome will be change in the Alcohol Use Disorders Identification Test (AUDIT) score between the 6-month follow-up and baseline assessments. Secondary outcomes will include the number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health. Assessments will be completed at baseline, at the end of treatment, and at 6 months follow-up. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models. DISCUSSION:The "Selge" program is the first and only internet program for the intervention of alcohol misuse in Estonia. If proven effective, it will foster progress in the intervention of alcohol misuse in the Estonian population and be implemented as a standard program amidst the continuum of intervention and care. TRIAL REGISTRATION:Current Controlled Trials ISRCTN48753339 registered 04/06/2019 retrospectively.

SUBMITTER: Kaal E

PROVIDER: S-EPMC7251728 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial.

Kaal Esta E Schaub Michael P MP Wenger Andreas A Ülesoo Triin T Blankers Matthijs M Haug Severin S Ebert David D DD Riper Heleen H Keough Matthew M Noormets Helen H Kilp Karin K

BMC public health 20200527 1

<h4>Background</h4>Despite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000's, most of the country's alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level.<h4>Methods</h4>A two-arm randomized controll ...[more]

PMID: 32460799

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Project description:Background and aimsEstonia has one of the highest alcohol-attributable mortality rates within the European Union. The aim of this study was to estimate the efficacy of an on-line self-help intervention to reduce problem drinking at the population level.DesignOn-line open randomized controlled trial with an 8-week intervention and an active control group (intervention n = 303, control n = 286). Assessments took place at baseline and at 6 months follow-up.SettingOn- and offline channels were used for population-based recruitment within a nation-wide prevention campaign in Estonia.ParticipantsInclusion criteria were age ≥ 18 years, heavy drinking [Alcohol Use Disorders Identification (AUDIT) test score ≥ 8], literacy in Estonian and at least weekly access to the internet; n = 589 participants were randomized (50% male, 1% other; mean age 37.86 years; 45% with higher level of education).Intervention and comparatorThe intervention consisted of 10 modules based on principles of cognitive-behavioral therapy and motivational interviewing. The active control group received access to a website with a self-test including personalized normative feedback and information for standard alcohol treatment.MeasurementsThe primary outcome was AUDIT scores at 6 months follow-up adjusted for baseline scores.FindingsIntention-to-treat analyses were applied. Missing data were addressed by using baseline observation carried forward (BOCF) and multiple imputation by chained equations (MI); 175 completed follow-up in the intervention group and 209 in the control group. AUDIT score at follow-up was significantly smaller in the intervention [BOCF mean = 13.91, standard deviation (SD) = 7.61, MI mean = 11.03, SD = 6.55] than control group (BOCF mean = 15.30, SD = 7.31; MI mean = 14.30, SD = 7.21), with a group difference of -1.38 [95% confidence interval (CI) = -2.58, -0.18], P = 0.02 for BOCF and -3.26 (95% CI = -2.01, -4.51), P < 0.001 for MI.ConclusionsA randomized controlled trial has found that an on-line self-help intervention with minimal guidance was effective at reducing problem drinking in Estonia.

Project description:BACKGROUND:Alcohol misuse and emotional problems (ie, depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based treatment options for these young adults. OBJECTIVE:The main goal of this study is to develop and test the efficacy of an integrated, online self-help program designed to target both alcohol misuse and emotional problems. METHODS:A two-arm randomized controlled trial design will be used to compare the efficacy of the online integrated treatment to a psychoeducational control group. A target sample of 214 participants will be recruited and randomly assigned to either condition. The integrated treatment will last 8 weeks, and participants will work through 12 modules. Modules will incorporate content based on principles of cognitive behavioral therapy and motivational interviewing. Participants in the control group will receive links to psychoeducational resources and will have access to the full treatment after follow-up. The primary outcome will be the number of Canadian standard drinks consumed in the week leading up the assessment. Secondary outcomes of interest include symptoms of depression, anxiety, alcohol-related problems, quality of life, and use of other drugs. Assessments will be completed at 3 time-points: at baseline, at the end of treatment (ie, 8 weeks), and at follow-up (ie, 24 weeks). Upon completion, data will be analyzed using generalized linear mixed models. RESULTS:Data collection began in June 2018 and will continue until January 2020. Final study results will be submitted for publication by July 2020. CONCLUSIONS:Currently, there are no integrated treatments designed to target alcohol misuse and the range of emotional problems experienced by young adults. This research stands to provide an effective, accessible (ie, Web-based), and feasible option to treat the many struggling young adults in this country. TRIAL REGISTRATION:ClinicalTrials.gov ID NCT03406039; https://clinicaltrials.gov/ct2/show/NCT03406039 (Archived by WebCite at http://www.webcitation.org/72fDefnrh). REGISTERED REPORT IDENTIFIER:PRR1-10.2196/11298.

Project description:BackgroundThe ubiquity of Internet connectivity, and widespread unmet needs, requires investigations of digital interventions for people seeking help with their drinking. The objective of this study was to test the effectiveness of a digital alcohol intervention compared to existing online resources for help seekers.MethodsThis parallel randomised controlled trial included 2129 risky drinkers with access to a mobile phone and aged 18 years or older. Randomised sub-studies investigated consent procedures and control group design. Simple computerised randomisation was used. Participants were aware of allocation after randomisation; research personnel were not. The digital intervention was designed around weekly monitoring of alcohol consumption followed by feedback and tools for behaviour change. Primary outcomes were total weekly consumption (TWC) and frequency of heavy episodic drinking (HED), measured 2 and 4 months post-randomisation.ResultsBetween 25/04/2019 and 26/11/2020, 2129 participants were randomised (intervention: 1063, control: 1066). Negative binomial regression was used to contrast groups, with both Bayesian and maximum likelihood inference. The posterior median incidence rate ratio (IRR) of TWC was 0.89 (95% CI = 0.81;0.99, 98.2% probability of effect, P-value = 0.033) at 2 months among 1557 participants and 0.77 (95% CI = 0.69;0.86, > 99.9% probability of effect, P-value < 0.001) at 4 months among 1429 participants. For HED, the IRR was 0.83 (95% CI = 0.75;0.93, > 99.9% probability of effect, P-value = 0.0009) at 2 months among 1548 participants and 0.71 (95% CI = 0.63;0.79, probability of effect > 99.9%, P-value < 0.0001) at 4 months among 1424 participants. Analyses with imputed data were not markedly different.ConclusionsA digital alcohol intervention produced self-reported behaviour change among online help seekers in the general population. The internal and external validity of this trial is strong, subject to carefully considered study limitations arguably inherent to trials of this nature. Limitations include higher than anticipated attrition to follow-up and lack of blinding.Trial registrationThe trial was prospectively registered ( ISRCTN48317451 ).

Project description:BackgroundDigital self-help interventions for reducing the use of alcohol tobacco and other drugs (ATOD) have generally shown positive but small effects in controlling substance use and improving the quality of life of participants. Nonetheless, low adherence rates remain a major drawback of these digital interventions, with mixed results in (prolonged) participation and outcome. To prevent non-adherence, we developed models to predict success in the early stages of an ATOD digital self-help intervention and explore the predictors associated with participant's goal achievement.MethodsWe included previous and current participants from a widely used, evidence-based ATOD intervention from the Netherlands (Jellinek Digital Self-help). Participants were considered successful if they completed all intervention modules and reached their substance use goals (i.e., stop/reduce). Early dropout was defined as finishing only the first module. During model development, participants were split per substance (alcohol, tobacco, cannabis) and features were computed based on the log data of the first 3 days of intervention participation. Machine learning models were trained, validated and tested using a nested k-fold cross-validation strategy.ResultsFrom the 32,398 participants enrolled in the study, 80% of participants did not complete the first module of the intervention and were excluded from further analysis. From the remaining participants, the percentage of success for each substance was 30% for alcohol, 22% for cannabis and 24% for tobacco. The area under the Receiver Operating Characteristic curve was the highest for the Random Forest model trained on data from the alcohol and tobacco programs (0.71 95%CI 0.69-0.73) and (0.71 95%CI 0.67-0.76), respectively, followed by cannabis (0.67 95%CI 0.59-0.75). Quitting substance use instead of moderation as an intervention goal, initial daily consumption, no substance use on the weekends as a target goal and intervention engagement were strong predictors of success.DiscussionUsing log data from the first 3 days of intervention use, machine learning models showed positive results in identifying successful participants. Our results suggest the models were especially able to identify participants at risk of early dropout. Multiple variables were found to have high predictive value, which can be used to further improve the intervention.

Project description:BackgroundAlcohol use is a major contributor to health loss. Many persons with harmful use or alcohol dependence do not obtain treatment because of limited availability or stigma. They may use internet-based interventions as an alternative way of obtaining support. Internet-based interventions have previously been shown to be effective in reducing alcohol consumption in studies that included hazardous use; however, few studies have been conducted with a specific focus on harmful use or alcohol dependence. The importance of therapist guidance in internet-based cognitive behavioral therapy (ICBT) programs is still unclear.ObjectiveThis trial aims to investigate the effects of a web-based alcohol program with or without therapist guidance among anonymous adult help-seekers.MethodsA three-armed randomized controlled trial was conducted to compare therapist-guided ICBT and self-help ICBT with an information-only control condition. Swedish-speaking adult internet users with alcohol dependence (3 or more International Classification of Diseases, Tenth Revision criteria) or harmful alcohol use (alcohol use disorder identification test>15) were included in the study. Participants in the therapist-guided ICBT and self-help ICBT groups had 12-week access to a program consisting of 5 main modules, as well as a drinking calendar with automatic feedback. Guidance was given by experienced therapists trained in motivational interviewing. The primary outcome measure was weekly alcohol consumption in standard drinks (12 g of ethanol). Secondary outcomes were alcohol-related problems measured using the total alcohol use disorder identification test-score, diagnostic criteria for alcohol dependence and alcohol use disorder, depression, anxiety, health, readiness to change, and access to other treatments or support. Follow-up was conducted 3 (posttreatment) and 6 months after recruitment.ResultsDuring the recruitment period, from March 2015 to March 2017, 1169 participants were included. Participants had a mean age of 45 (SD 13) years, and 56.72% (663/1169) were women. At the 3-month follow-up, the therapist-guided ICBT and control groups differed significantly in weekly alcohol consumption (-3.84, 95% Cl -6.53 to -1.16; t417=2.81; P=.005; Cohen d=0.27). No significant differences were found in weekly alcohol consumption between the self-help ICBT group and the therapist-guided ICBT at 3 months, between the self-help ICBT and the control group at 3 months, or between any of the groups at the 6-month follow-up. A limitation of the study was the large number of participants who were completely lost to follow-up (477/1169, 40.8%).ConclusionsIn this study, a therapist-guided ICBT program was not found to be more effective than the same program in a self-help ICBT version for reducing alcohol consumption or other alcohol-related outcomes. In the short run, therapist-guided ICBT was more effective than information. Only some internet help-seekers may need a multisession program and therapist guidance to change their drinking when they use internet-based interventions.Trial registrationClinicalTrials.gov NCT02377726; https://clinicaltrials.gov/ct2/show/NCT02377726.

Project description:Many young people are reluctant to seek professional help for mental health problems, preferring to rely on their friends for support. It is therefore important to ensure that adolescents can identify signs of psychological distress in their peers, talk to them about these, and help them access appropriate services when necessary. The current study examined adolescents' ability to recognise symptoms of depression and alcohol misuse, perceived barriers to help-seeking, and their intentions to encourage a peer to seek help from a range of informal and formal help sources.The current study used baseline data from a randomised controlled trial of a school-based intervention that teaches adolescents how to overcome barriers to accessing professional help for mental health and substance use problems (MAKINGtheLINK). Participants (n = 2456) were presented with two vignettes portraying depression and alcohol misuse, respectively, and were asked to identify the problems described. Participants provided data on their past help-seeking behaviour, confidence to help a peer, perceived barriers to help-seeking, and intentions to encourage a peer to seek help.Health professionals were the main source of help that participants had relied on for depressive symptoms, followed by friends and parents. In contrast, friends were the main source of help that participants had relied on for alcohol and other drug problems, followed by health professionals and parents. Just over half of the sample correctly identified the problems described in the two vignettes, although the majority of participants were confident that they could talk to a peer and help them seek professional help if needed. Most agreed that the vignettes described problems that warranted professional help, however approximately half the sample was unsure or considered it unlikely that they would seek help if they experienced similar problems. For both disorders, participants were most likely to encourage a peer to seek help from their family, followed by formal help sources and friends.While the results point towards a greater willingness to approach formal help sources, particularly for depression, peers remain an important source of support for young people experiencing mental health and substance use problems.

Project description:AimsOnline interventions reduce the treatment gap between the number of people with alcohol misuse and people who actually receive help. This study investigated the effectiveness and predictors of success of a Belgian online help programme.MethodsA real-life retrospective open cohort study evaluating the guided and unguided internet intervention on the Belgian online platform alcoholhulp.be. The intervention consisted of a 12-week programme based upon cognitive behaviour therapy, motivational interviewing and acceptance and commitment therapy. Inclusion criteria are age above 18 years, recording of alcohol consumption in the daily journal for at least 2 weeks, and minimum 2 chat sessions in the guided group.Outcomes were weekly alcohol consumption after 6 and 12 weeks and treatment response (drinking less than 10 or 20 standard units (SU) per week). Additional analysis was done on predictors of success.ResultsA total of 460 participants in the guided group and 968 in the self-help group met the inclusion criteria. Average baseline alcohol consumption in the two groups was 40 SU per week. Alcohol consumption decreased by 31 SU (Cohen's d 1.17, p < 0.001) after 12 weeks in the guided group and 23 SU (Cohen's d 0.83, p < 0.001) in the self-help group. The treatment response below 20 SU per week was 88% for the guided group and 73% for the self-help group. Significantly better results were obtained in the guided group compared to the self-help group (p < 0.005). Participants with a higher baseline alcohol consumption had a higher decrease in alcohol consumption in both groups. The personal goal to quit, the absence of drug use, a lower baseline alcohol consumption and a higher number of completed assignments predict a higher chance of treatment response. Attrition at 6 weeks was 26% in the guided group and 63% in the self-help group and increased to 59% and 82% respectively at 12 weeks.ConclusionsBoth guided and unguided internet interventions are effective in reducing alcohol consumption and achieving the guideline for participants motivated to use the platform on a regular base, with better results in guided intervention.

Dataset Information

Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial.

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Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial.

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