- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
-
Study Plan
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
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Alcohol Consumption
-
Centre for Addiction and Mental HealthUniversity of HoustonCompleted
-
Wayne State UniversityCompleted
-
Institut national de prevention et d'education...CompletedHazardous Alcohol Consumption
-
International Agency for Research on CancerUniversidad de Murcia; Federico II University; University of Tromso; Imperial College... and other collaboratorsCompletedNo Condition, Focus: Metabolites of Alcohol Consumption
-
Denver Health and Hospital AuthorityMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.CompletedModerate Alcohol Consumption (1-3 Drinks Per Day)
-
Jordi Gol i Gurina FoundationSocietat Catalana de Medicina Familiar i Comunitària (CAMFIC); Associació Catalana... and other collaboratorsUnknownAlcohol Consumption | Traffic Accident | Risk Perception of Driving After Alcohol ConsumptionSpain
-
Technische Universität DresdenCharite University, Berlin, GermanyCompletedHigh-risk Alcohol Consumption Pattern | Low-risk Alcohol Consumption PatternGermany
-
University of WashingtonNational Institutes of Health (NIH); National Institute on Aging (NIA); Seattle...Active, not recruitingMild to Heavy Alcohol ConsumptionUnited States
-
Brown UniversityCompletedPhysical Activity | Stress, Psychological | Sleep | Loneliness | Diet Habit | Emotional Regulation | Alcohol Consumption, YouthUnited States
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
Clinical Trials on Check Your Drinking
-
King's College LondonCompletedAlcohol ConsumptionUnited Kingdom
-
Centre for Addiction and Mental HealthUniversity of HoustonCompleted
-
Centre for Addiction and Mental HealthUniversity of Manitoba; University of CalgaryCompletedAlcohol Consumption | GamblingCanada
-
Centre for Addiction and Mental HealthCompleted
-
Centre for Addiction and Mental HealthCompleted
-
King's College LondonCompletedAlcohol ConsumptionUnited Kingdom
-
Centre for Addiction and Mental HealthCompletedDepression | Problem DrinkingCanada
-
Centre for Addiction and Mental HealthCompletedAlcohol ConsumptionCanada
-
Centre for Addiction and Mental HealthHealth CanadaCompleted
-
The Miriam HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed