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Completed

NCT Number: NCT03601793

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

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.

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Key information

Conditions

Alcohol Problem Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol Help Center

Behavioral

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

Assistance from a health educator

Behavioral

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

Primary outcomes

  1. Drinks preceding week

    Time frame: 3 and 6 months

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

  2. Heavy drinking days preceding week

    Time frame: 3 and 6 months

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

Secondary outcomes

  1. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: Baseline, 3 month follow up, 6 month follow up

    Assessment of alcohol problems

  2. Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)

    Time frame: Baseline, 3 month follow up, 6 month follow up

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

  3. EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)

    Time frame: 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).

  4. DSM criteria

    Time frame: Baseline

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

  5. Previously received treatment or help for alcohol concerns

    Time frame: 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)

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

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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