What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial

December 5, 2014 updated by: John Cunningham, Centre for Addiction and Mental Health
The major objective of this project is to conduct a randomized controlled trial comparing the impact of the normative feedback and other personalized feedback components of the Check Your Drinking (CYD) Internet-based intervention in the general population. Eligible problem drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design - to receive just the normative feedback component of the CYD intervention, just the other personalized feedback information, to a no intervention control condition, or to receive the full CYD intervention. The no intervention control condition will not be sent any intervention materials but will instead be sent a list of the different components of the CYD feedback and will be asked to think about how useful they would find each of them. All participants will be followed-up at 3 months.

Study Overview

Study Type

Interventional

Enrollment (Actual)

804

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • problem drinkers as measured by an AUDIT score of 8 or more

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full personalized feedback
Participant provided with the full CYD personalized feedback summary.
The CYD provides problem drinkers with a personalized summary of their drinking that compares his or her drinking with that of the general population. The CYD also provides an assessment of the severity of the person's drinking problem.
Experimental: Only normative feedback
Participant provided with just the normative feedback component of the CYD personalized feedback summary.
The CYD provides problem drinkers with a personalized summary of their drinking that compares his or her drinking with that of the general population. The CYD also provides an assessment of the severity of the person's drinking problem.
Experimental: Just other personalized feedback
Participant provided with all the other personalized feedback components of the CYD intervention (i.e., no normative feedback).
The CYD provides problem drinkers with a personalized summary of their drinking that compares his or her drinking with that of the general population. The CYD also provides an assessment of the severity of the person's drinking problem.
No Intervention: No intervention control
Participant provided with a list describing the components of the CYD intervention but not provided any personalized feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks in a typical week
Time Frame: 3 months
Number of drinks in a typical week
3 months
AUDIT-C score
Time Frame: 3 months
Composite measure of three drinking items - frequency of drinking, drinks per drinking day, frequency of 5+ drinking days
3 months
Highest number of drinks on one occasion
Time Frame: 3 months
Highest number of drinks on one occasion in the past 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Cunningham, Ph.D., Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 28, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

May 31, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 001/2012

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.

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