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

Alcohol Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874509
• Other study ID #: CFP 285651
• Status: Completed
• Phase: N/A
• First received: June 7, 2013
• Last updated: March 25, 2017
• Start date: June 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2017
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Hazardous Alcohol Consumption

Intervention

Behavioral:
• Check Your Drinking

• Alcohol Help Centre

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in number of drinks in a typical week from baseline	Sum of number of drinks consumed in a typical week	6 months, 1 year, 2 years
Secondary	Change in highest number of drinks on one occasion from baseline	Greatest amount drunk on one occasion	6 months, 1 year, 2 years