Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers
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| ClinicalTrials.gov Identifier: NCT01874509 |
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Recruitment Status :
Completed
First Posted : June 11, 2013
Last Update Posted : March 28, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcohol Consumption Hazardous Alcohol Consumption | Behavioral: Check Your Drinking Behavioral: Alcohol Help Centre | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 490 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers |
| Study Start Date : | June 2013 |
| Actual Primary Completion Date : | February 2015 |
| Actual Study Completion Date : | February 2016 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Check Your Drinking |
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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.
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Behavioral: Alcohol Help Centre |
- 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.
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874509
| Canada, Ontario | |
| Centre for Addiction and Mental Health | |
| Toronto, Ontario, Canada, M5S 2S1 | |
| Principal Investigator: | John A Cunningham, Ph.D. | Centre for Addiction and Mental Health |
| Responsible Party: | John Cunningham, Senior Scientist, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT01874509 |
| Other Study ID Numbers: |
CFP 285651 |
| First Posted: | June 11, 2013 Key Record Dates |
| Last Update Posted: | March 28, 2017 |
| Last Verified: | March 2017 |
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Alcohol Drinking Drinking Behavior |