- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01608763
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
Status
Completed
Conditions
Intervention / Treatment
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.
Clinical Trials on Problem Drinking
-
Karolinska InstitutetCompleted
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol Drinking | Problem DrinkingUnited States
-
Oregon Research Behavioral Intervention Strategies...CompletedAdolescent Problem Behavior | Adolescent DrinkingUnited States
-
The University of Texas Health Science Center at...Robert Wood Johnson Foundation; Agency for Healthcare Research and Quality...CompletedSmoking | Sedentary Lifestyle | Problem Drinking | Unhealthy DietUnited States
-
Mackay Memorial HospitalNational Science Council, TaiwanCompletedProblem DrinkingTaiwan
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol; Use, ProblemUnited States
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol; Use, ProblemUnited States
-
University of Central FloridaEnrolling by invitation
-
Brown UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Centre for Addiction and Mental HealthCompletedDepression | Problem DrinkingCanada
Clinical Trials on Check Your Drinking (CYD) personalized feedback intervention
-
King's College LondonCompletedAlcohol ConsumptionUnited Kingdom
-
Centre for Addiction and Mental HealthUniversity of Manitoba; University of CalgaryCompletedAlcohol Consumption | GamblingCanada
-
King's College LondonCompletedAlcohol ConsumptionUnited Kingdom
-
Centre for Addiction and Mental HealthUniversity of HoustonCompleted
-
Centre for Addiction and Mental HealthHealth CanadaCompleted
-
Centre for Addiction and Mental HealthCompleted
-
Centre for Addiction and Mental HealthCompletedDepression | Problem DrinkingCanada
-
Centre for Addiction and Mental HealthCanadian Institutes of Health Research (CIHR)CompletedAlcohol Consumption | Hazardous Alcohol ConsumptionCanada
-
Centre for Addiction and Mental HealthCompletedAlcohol ConsumptionCanada
-
The Miriam HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed