Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers

March 25, 2017 updated by: John Cunningham, Centre for Addiction and Mental Health

Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings.

One promising strategy is Internet-based interventions for problem drinkers. The first randomized controlled trial found that the investigators could reduce alcohol consumption by about six drinks per week at a six-month follow-up using a minimal, personalized feedback Internet-based intervention. The investigators second randomized trial demonstrated that an extended Internet-based intervention that contained a range of cognitive-behavioural and relapse prevention tools could produce greater reductions in problem drinking compared to that provided by the same minimal intervention at a six-month follow-up. Building upon this research, the current project will assess whether this extended Internet-based intervention can have a sustained impact on problem drinking. Specifically, the major objective of this project is to conduct a randomized controlled trial comparing the impact of an extended Internet-based self-help intervention for problem drinkers to a minimal Internet-based intervention in the general population of problem drinkers over a two year period.

Problem drinking participants will be recruited through media advertisements across Canada and will be randomly assigned to the minimal or extended Internet-based interventions. Six-month, twelve-month and two-year drinking outcomes will be compared between experimental conditions. It is predicted that participants receiving the extended Internet intervention will display sustained improved drinking outcomes compared to participants in the minimal Internet intervention condition. This programmatic line of research will advance the science of Internet-mediated intervention.

Study Overview

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:•Resident of Canada

  • 18 years of age or over
  • A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
  • Indicate an interest in receiving self-help materials
  • Have home access to the Internet
  • Are willing to participate in follow-up at six month, twelve month and 2 year intervals

Exclusion Criteria:None

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Check Your Drinking screener
Internet based program of lower intensity as compared to the "Alcohol Help Centre. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding abstinence.
Experimental: Alcohol Help Centre
Internet based program of higher intensity as compared to the "Check Your Drinking" intervention. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding abstinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in AUDIT-C from baseline
Time Frame: 6 months, 1 year, 2 years
A composite measure of three quantity/frequency drinking items (number of drinks per drinking day; frequency of alcohol consumption; frequency of 5+ drinking days). Developed by the world health organization.
6 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of drinks in a typical week from baseline
Time Frame: 6 months, 1 year, 2 years
Sum of number of drinks consumed in a typical week
6 months, 1 year, 2 years
Change in highest number of drinks on one occasion from baseline
Time Frame: 6 months, 1 year, 2 years
Greatest amount drunk on one occasion
6 months, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 25, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFP 285651

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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