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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Cunningham, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01608763
First received: May 28, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Problem Drinking
Behavioral: Check Your Drinking (CYD) personalized feedback intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Drinks in a typical week [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of drinks in a typical week

  • AUDIT-C score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Composite measure of three drinking items - frequency of drinking, drinks per drinking day, frequency of 5+ drinking days

  • Highest number of drinks on one occasion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Highest number of drinks on one occasion in the past 3 months


Enrollment: 804
Study Start Date: May 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Full personalized feedback
Participant provided with the full CYD personalized feedback summary.
Behavioral: Check Your Drinking (CYD) personalized feedback intervention
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.
Behavioral: Check Your Drinking (CYD) personalized feedback intervention
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).
Behavioral: Check Your Drinking (CYD) personalized feedback intervention
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608763

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: John Cunningham, Ph.D. Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: John Cunningham, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01608763     History of Changes
Other Study ID Numbers: 001/2012
Study First Received: May 28, 2012
Last Updated: December 11, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014