Skills-training for Reducing Risky Alcohol Use in App Form

Study Overview
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Brief Summary
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This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering. The Telecoach web app delivers skills training in the form of exercises commonly used in psychosocial interventions for risky alcohol use. The controll condition is a web app providing information on the effects of alcohol on the consumers' health.

Detailed Description
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This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering. Individuals seeking help for problematic alcohol use on the internet will get access to a webpage with information about the study. Individuals leaving informed consent are asked to fill out questionnaires about alcohol use, depression, anxiety and information on gender and weight. Those with excessive alcohol use (>14 standard glasses/week for men and > 9 for women) are randomized into one of two groups: 1. Access to the Telecoach web-app and 2. Access to a control condition with an information-providing web-app. Outcomes on alcohol use are gathered by electronic self-registration at 6, 12 and 26 weeks after study initiation. Additional questions on the users' satisfaction with the app assigned to them and other support for problematic alcohol used during the research period at 26 weeks. The Telecoach web-app is a skills-training app developed for use on a mobile smart-phone. The skills-training components are common to psychosocial treatment protocols for problematic alcohol consumption. The control condition web-app is a simple text-based app providing information on the effects of alcohol on the consumers' health. Outcomes will be reported, analyzed and discussed in a scientific article.

Official Title
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Reducing Risky Alcohol Consumption Using Skills-training in the App-form: A Randomized Controlled Study in the General Population.

Conditions
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Alcohol Abuse, Alcohol Use Disorder, Alcohol Drinking, Alcohol Dependence, Alcohol; Harmful Use

Intervention / Treatment
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* Behavioral: Telecoach
* Behavioral: TeleCoach control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years Risky alcohol consumption defined as Alcohol Use Disorders Identification Test (AUDIT) scores of ≥6 points for women and ≥ 8 points for men. Exclusion Criteria: Severe depression, defined as a MADRS-S score of > 30 Sucide risk, defined as a MADRS-S, item 9 (Lust for life) score > 4 Drug abuse, defined as a score of ≥ 8 on the DUDIT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Note: A pilot period with interim 6-week analyses following recruitment of about 10% of the maximum anticipated sample of 1000 is part of the study. This offers an opportunity to assess trial continuation from an ethical perspective. The rationale for this is that individuals with relatively severe levels of alcohol use can be included in the trial and the investigators harbor a concern that the components in the intervention and control conditions might be insufficient to support the participants in remaining stable or reducing their alcohol intake. The pilot period covers a recruitment period from Dec 7, 2019 to February 15, 2019 (n=89) and includes a 6-week follow-up. The interim analysis from May 1, 2019 indicates group declines in alcohol use over the 6-week follow-up period for both conditions, suggesting that continuation of the trial is warranted. Pilot participants will be included in the final study sample.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telecoach<br>A skills-training web-app teaching skills for reducing problematic alcohol use. | Behavioral: Telecoach<br>* A skills-training web-app teaching skills for reducing problematic alcohol use.<br>|
| Active Comparator: TeleCoach control<br>A web-app giving information on health-related consequences of alcohol consumption. | Behavioral: TeleCoach control<br>* A web-app providing information about the health-related consequences of alcohol consumption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alcohol consumption according to the 7-day Timeline Followback (TLFB) | Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared. | Time between screening measure and 26-week followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Drinking Questionnaire (DDQ) | The number of standard glasses (12g of ethanol) consumed and over how many hours for each day of a typical week the last month. | Baseline, 6, 12 and 26 week followups. | 
| Alcohol Use Disorders Identification Test (AUDIT) | 10 questions measuring alcohol consumption and alcohol-related problems. | Baseline and 26-week followup. | 
| Change in alcohol consumption according to the 7-day Timeline Followback (TLFB) | Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared. | Baseline, 6- and 12-week followups. | 
| Readiness Ruler | A visual analogue scale measuring participants' motivation to change their alcohol consumption. | Baseline and 26-week followup. | 
| DSM-5 Alcohol use disorder criteria. | Criteria for the diagnosis Alcohol use disorder in the the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) | Baseline | 
| Penn Alcohol Craving Scale (PACS) | 5 items to measure participants' craving for alcohol. | Baseline, 6, 12 and 26 week followups. | 
| Alcohol Abstinence Self Efficacy scale (AASE) | 12 items for measuring self efficacy in the domain of abstaining from drinking alcohol. | Baseline, 6, 12 and 26 week followups. | 
| Drug Use Disorders Identification Test (DUDIT) | 11 items for measuring participants' drug consumption and drug-related problems. | Baseline | 
| Montgomery Åsberg Depression Rating Scale - Self-rating version (MADRS-S) | 9 questions measuring symptoms of depression | Baseline, 6, 12 and 26 week followups. | 
| Generalized Anxiety Disorder-7 (GAD-7) | 7 questions measuring symptoms of anxiety | Baseline, 6, 12 and 26 week followups. | 
| Treatment questions (7 questions regarding access to other help and support for problematic alcohol use). | 7 questions regarding access to other help and support for problematic alcohol use. | Baseline and 26 week followup. | 
| Usability questions regarding the participants' experience of using the web-app they were assigned. | Questions regarding the participants' experience of using the web-app they were assigned. | 26 week followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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App, Randomized Controlled Trial, Internet, Mobile phone, Smartphone, Alcohol, Substance use