An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.

Detailed Description
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This project aims to study the previously evaluated multi-module internet intervention Alcohol Help Center delivered with assistance from a health educator (AHC+A). The assistance will be in the form of email contact with the participant during the first two weeks after randomization. AHC+A will be tested against a group receiving access to the intervention without any such assistance (AHC). The Investigators hypothesize that participants allocated to AHC+A will display significant reductions in drinking (drinks preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared to AHC participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC engagement with the intervention will mediate any effects on drinking behavior. A 2-arm parallel group randomized controlled trial will be used to test these specified hypotheses. Follow-ups will be conducted at 3 and 6 months after randomization. Online media advertisements will be used to recruit people with current alcohol problems, and will target people who are 'experiencing difficulties in controlling or cutting down on their drinking.' The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).

Official Title
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Using Assistance From a Health Educator to Increase Effectiveness of an Internet Intervention for Alcohol Problems. A Randomized Controlled Trial

Conditions
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Alcohol Problem

Intervention / Treatment
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* Behavioral: Alcohol Help Center
* Behavioral: Assistance from a health educator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A score of 8 or more on the Alcohol Use Disorder Identification Test (AUDIT) A preceding week alcohol consumption of 14 standard drinks or more Exclusion Criteria: Being under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet intervention with assistance<br>This arm is given access to the internet intervention Alcohol Help Center with email assistance from a health educator during the first two weeks after randomization. | Behavioral: Alcohol Help Center<br>* An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems<br>Behavioral: Assistance from a health educator<br>* This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks<br>|
| Active Comparator: Internet intervention without assistance<br>This arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator. | Behavioral: Alcohol Help Center<br>* An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinks preceding week | Change in the number of standard drinks consumed during preceding week from baseline | 3 and 6 months | 
| Heavy drinking days preceding week | Change in the number of heavy drinking days during preceding week from baseline | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use Disorders Identification Test (AUDIT) | Assessment of alcohol problems | Baseline, 3 month follow up, 6 month follow up | 
| Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) | Assessment of alcohol consumption (the first 3 items in AUDIT) | Baseline, 3 month follow up, 6 month follow up | 
| EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L) | Instrument measuring five health-related quality of life dimensions. Each dimension has five levels ranging from no problems to extreme problems. The dimensions can be combined into an index value between 0 (lowest) and 1 (highest). In addition to the five dimensions, a visual analogue scale item allows participants to measure health outcomes that reflect the participant's judgement. Endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). | Baseline, 3 month follow up, 6 month follow up | 
| DSM criteria | The 11 DSM criteria of alcohol use disorders (yes/no) | Baseline | 
| Previously received treatment or help for alcohol concerns | Questions about what kind of treatment or help for alcohol concerns the participant has received previously | Baseline (treatment or help ever/in the past 12 months), 3 month follow up (treatment or help in the past 3 months), 6 month follow up (treatment or help in the past 3 months) |