Clinical trial NCT01874509: Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers
Official title: Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Hazardous Alcohol Consumption
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-06-11
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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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Primary outcomes:
measure: Change in AUDIT-C from baseline
timeFrame: 6 months, 1 year, 2 years
Secondary outcomes:
measure: Change in number of drinks in a typical week from baseline
timeFrame: 6 months, 1 year, 2 years
measure: Change in highest number of drinks on one occasion from baseline
timeFrame: 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John A Cunningham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham JA, Shorter GW, Murphy M, Kushnir V, Rehm J, Hendershot CS. Randomized Controlled Trial of a Brief Versus Extended Internet Intervention for Problem Drinkers. Int J Behav Med. 2017 Oct;24(5):760-767. doi: 10.1007/s12529-016-9604-5.
citation: Cunningham JA, Hendershot CS, Rehm J. Randomized controlled trial of a minimal versus extended Internet-based intervention for problem drinkers: study protocol. BMC Public Health. 2015 Jan 21;15:21. doi: 10.1186/s12889-015-1347-8.