Evaluation of an Internet-based Intervention for Hazardous Drinkers

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the investigators internet-based intervention is effective to help hazardous drinkers reducing their alcohol consumption.

Conditions
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Hazardous Alcohol Consumption

Intervention / Treatment
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* Behavioral: interactive online programme to reduce alcohol consumption
* Behavioral: Minimum information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based alcohol programme<br>Participants could log on to their account and access the programme whenever they wanted to. They received automated email reminders inviting them to use follow-up tools, especially the diary in order to register their alcohol intake on the previous week: 4 weeks after starting the programme, so that they would take advantage of the monitoring stage in case they had not spontaneously done so. 2 weeks later for 6-week follow-up. | Behavioral: interactive online programme to reduce alcohol consumption<br>* The programme includes several steps: personalized feedback on alcohol consumption and related risks reviewing motivations and fears regarding drinking reduction analyse of drinking habits reduction goal setting follow-up tools (alcohol diary, craving scales, well-being scales) a final screen allowing participants to monitor their progress through graphs and automatically adapted comments.<br>|
| Placebo Comparator: Minimum information<br>Participants could log on to their account and access the programme whenever they wanted to. At 6 week follow-up they received an automated email reminder inviting them to use the diary in order to register their alcohol intake on the previous week. | Behavioral: Minimum information<br>* This intervention includes: information about hazardous drinking an alcohol diary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weekly Alcohol Intake | The unit of standard drink is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks. | baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Change in Weekly Alcohol Intake | (6 weeks minus baseline)/baseline | baseline and 6 weeks | 
| Category of Change in Weekly Alcohol Intake | Category of change in weekly alcohol intake (WAI) is a 3-level categorical variable whose values are: clinically significant reduction in WAI, defined as a decrease of 10% or over; clinically significant increase in WAI, defined as an increase of 10% or over if WAI at baseline is positive, or any increase if WAI at baseline is 0); and no clinically significant change, which includes all other cases. | baseline and 6 weeks | 
| Change in the Number of Excessive Drinkers | The number of excessive drinkers is the number of participants whose weekly alcohol intake exceeds guidelines, i.e. 21 or 14 standard drinks (male/female) per week | baseline and 6 weeks |