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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03601793
Enrollment
236
Registered
2018-07-26
Start date
2018-08-01
Completion date
2019-06-19
Last updated
2019-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Problem

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).

Interventions

BEHAVIORALAlcohol Help Center

An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems

BEHAVIORALAssistance from a health educator

This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Drinks preceding week3 and 6 monthsChange in the number of standard drinks consumed during preceding week from baseline
Heavy drinking days preceding week3 and 6 monthsChange in the number of heavy drinking days during preceding week from baseline

Secondary

MeasureTime frameDescription
EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)Baseline, 3 month follow up, 6 month follow upInstrument 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).
Alcohol Use Disorders Identification Test (AUDIT)Baseline, 3 month follow up, 6 month follow upAssessment of alcohol problems
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
DSM criteriaBaselineThe 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 upAssessment of alcohol consumption (the first 3 items in AUDIT)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026