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

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ClinicalTrials.gov Identifier: NCT01608763
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
John Cunningham, Centre for Addiction and Mental Health

Brief Summary:
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 or disease Intervention/treatment Phase
Problem Drinking Behavioral: Check Your Drinking (CYD) personalized feedback intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 804 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial
Study Start Date : May 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Drinks in a typical week [ Time Frame: 3 months ]
    Number of drinks in a typical week

  2. 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. Highest number of drinks on one occasion [ Time Frame: 3 months ]
    Highest number of drinks on one occasion in the past 3 months



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


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): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014