Testing the Efficacy of an Online Alcohol Intervention

Study Overview
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Brief Summary
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The purpose of this study is to test whether an online multi session alcohol intervention improves treatment effect compared to single session screening with feedback only. All participants in the trial received a single session screening procedure including individualized normative feedback (usual care). Additionally, half of the participants received a simple online booklet about the effects of alcohol. The other half received an online multi session follow up program.

Detailed Description
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Aims: Test whether a multi session alcohol intervention improves treatment effect (i.e., reduced consumption of alcohol) compared to single session screening with feedback. Design: Randomized controlled trial (RCT). Subjects in both conditions receives a single session screening procedure including individualized normative feedback. The control group receives an online booklet about the effects of alcohol. The treatment group receives the multi session follow up program Balance . Setting: Online study in Norway. Participants: At-risk drinkers is recruited through internet advertisements and randomly assigned to one of two conditions.

Official Title
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Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention Balance.

Conditions
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Hazardous Drinking, Harmful Drinking

Intervention / Treatment
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* Behavioral: Online screening and feedback
* Behavioral: Online booklet.
* Behavioral: Online multi session follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hazardous or harmful drinking (i.e., a FAST-score of 3 or more) Exclusion Criteria: underage (<18) not provided a valid e-mail address not provided a valid (Norwegian) mobile phone number

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Receives two interventions: Online screening and feedback. Online booklet. | Behavioral: Online screening and feedback<br>* An online single session screening procedure including individualized normative feedback.<br>Behavioral: Online booklet.<br>* An online booklet that covers general information about alcohol, its effect on the brain and the body, potential risks and harms of drinking, and an account of the threshold values of sensible drinking<br>|
| Experimental: Extended follow-up<br>Receives two interventions: Online screening and feedback. Online multi session follow-up. | Behavioral: Online screening and feedback<br>* An online single session screening procedure including individualized normative feedback.<br>Behavioral: Online multi session follow-up<br>* An online multi session follow-up program (i.e., Balance). The central concept of Balance is to support continued self-regulation throughout the behavior change process. There are four key aspects of the program, the first is focus on goal setting and tracking of alcohol consumption on a day-to-day basis. The second on relapse prevention - for example, when clients report drinking more than their target, they receive individualized content aimed at preventing a full blown relapse. The third is emotion regulation, where content and assignments from positive psychology and from cognitive behavioral therapy are used. Finally, intervention covers alcohol education (i.e. the same topics as in the booklet provided to the control group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of standard alcohol units consumed during the previous seven days | Subjects are asked to indicate (through online questionnaires) how many standard alcohol units they consumed on each of the previous seven days, on a scale from zero to ten. Then a sum-score for weekly consumption is calculated, ranging from zero to 70. | measures six months after baseline (enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sick leave during last week | Sick leave was assessed with a yes or no response for each of the past seven days, and then accumulated, resulting in a score of zero to seven. Participants were instructed to report any sick leave regardless of reason. | Assessed at six months post baseline | 
| Negative consequences of alcohol consumption | Perceived negative consequences of own alcohol consumption, during the seven previous days, was assessed by a 13 item index, resulting in a sum score with a theoretical range from zero to 13. The items comprised: headache, nausea, anxiety, worn out, depressed, breaking a plan, breaking a date, sick leave, memory problems, bad conscience, conflict, destroyed something and injuries. | Assessed at six months post baseline | 
| Change in alcohol consumption | The change score for weekly consumption, from baseline to six months, is calculated based on the seven day consecutive measure (primary outcome). | Six months post baseline | 
| Number of days with alcohol consumption | Based on the seven day consecutive measure (primary outcome), the number of days with alcohol consumption is calculated. | Six months post baseline | 
| Number of alcohol binges | Based on the seven day consecutive measure (primary outcome), the number of days with a binge drinking episode is calculated. | Six months post baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, online intervention, hazardous drinking, harmful drinking, early intervention, behavior change intervention