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

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ClinicalTrials.gov Identifier: NCT01874509
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
John Cunningham, Centre for Addiction and Mental Health

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.


Condition or disease Intervention/treatment Phase
Alcohol Consumption Hazardous Alcohol Consumption Behavioral: Check Your Drinking Behavioral: Alcohol Help Centre Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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.
Behavioral: Check Your Drinking
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.
Behavioral: Alcohol Help Centre



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: John A Cunningham, Ph.D. Centre for Addiction and Mental Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior