What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial
This study is currently recruiting participants.
Verified December 2012 by Centre for Addiction and Mental Health
Sponsor:
Centre for Addiction and Mental Health
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 4, 2012
Last verified: December 2012
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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
| Estimated Enrollment: | 800 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | May 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
Contacts
| Contact: John Cunningham, Ph.D. | 416 535 8501 | john_cunningham@camh.net |
Locations
| Canada, Ontario | |
| Centre for Addiction and Mental Health | Recruiting |
| Toronto, Ontario, Canada, M5S 2S1 | |
| Contact: Michelle Murphy michelle_murphy@camh.net | |
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 4, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013