Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers
1 other identifier
interventional
490
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 28, 2017
March 1, 2017
1.7 years
June 7, 2013
March 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in AUDIT-C from baseline
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 Outcomes (2)
Change in number of drinks in a typical week from baseline
6 months, 1 year, 2 years
Change in highest number of drinks on one occasion from baseline
6 months, 1 year, 2 years
Study Arms (2)
Check Your Drinking screener
ACTIVE COMPARATORInternet 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.
Alcohol Help Centre
EXPERIMENTALInternet 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Related Publications (2)
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.
PMID: 27770293DERIVEDCunningham 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.
PMID: 25604206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John A Cunningham, Ph.D.
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 11, 2013
Study Start
June 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2016
Last Updated
March 28, 2017
Record last verified: 2017-03