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Completed

NCT Number: NCT01874509

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Who can participate

Healthy volunteers accepted: No

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

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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Treatment and study plan

Check Your Drinking

Behavioral

Alcohol Help Centre

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 11, 2013
Registry last updated
Mar 28, 2017

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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