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

Primary Purpose

Alcohol Consumption, Hazardous Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Check Your Drinking
Alcohol Help Centre
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Consumption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Check Your Drinking screener

Alcohol Help Centre

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in number of drinks in a typical week from baseline
Sum of number of drinks consumed in a typical week
Change in highest number of drinks on one occasion from baseline
Greatest amount drunk on one occasion

Full Information

First Posted
June 7, 2013
Last Updated
March 25, 2017
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01874509
Brief Title
Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers
Official Title
Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Hazardous Alcohol Consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Check Your Drinking screener
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Alcohol Help Centre
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Check Your Drinking
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Help Centre
Primary Outcome Measure Information:
Title
Change in AUDIT-C from baseline
Description
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.
Time Frame
6 months, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Change in number of drinks in a typical week from baseline
Description
Sum of number of drinks consumed in a typical week
Time Frame
6 months, 1 year, 2 years
Title
Change in highest number of drinks on one occasion from baseline
Description
Greatest amount drunk on one occasion
Time Frame
6 months, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Cunningham, Ph.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27770293
Citation
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.
Results Reference
derived
PubMed Identifier
25604206
Citation
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.
Results Reference
derived

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

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