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

Not Applicable
Completed
Conditions
Alcohol Problem
Interventions
Behavioral: Alcohol Help Center
Behavioral: Assistance from a health educator
Registration Number
NCT03601793
Lead Sponsor
Centre for Addiction and Mental Health
Brief Summary

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

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

1. 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

2. participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC

3. 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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
236
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Internet intervention with assistanceAlcohol Help CenterThis 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.
Internet intervention without assistanceAlcohol Help CenterThis arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator.
Internet intervention with assistanceAssistance from a health educatorThis 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.
Primary Outcome Measures
NameTimeMethod
Drinks preceding week3 and 6 months

Change in the number of standard drinks consumed during preceding week from baseline

Heavy drinking days preceding week3 and 6 months

Change in the number of heavy drinking days during preceding week from baseline

Secondary Outcome Measures
NameTimeMethod
Alcohol Use Disorders Identification Test (AUDIT)Baseline, 3 month follow up, 6 month follow up

Assessment of alcohol problems

DSM criteriaBaseline

The 11 DSM criteria of alcohol use disorders (yes/no)

Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)Baseline, 3 month follow up, 6 month follow up

Assessment of alcohol consumption (the first 3 items in AUDIT)

EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)Baseline, 3 month follow up, 6 month follow up

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).

Previously received treatment or help for alcohol concernsBaseline (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)

Questions about what kind of treatment or help for alcohol concerns the participant has received previously

Trial Locations

Locations (1)

Centre for Addiction and Mental Health

🇨🇦

Toronto, Ontario, Canada

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