Ultra-brief Intervention for Problem Drinkers
Primary Purpose
Problem Drinking, Alcoholism
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pamphlet-based personalized alcohol feedback (PAF)
control pamphlet condition
Sponsored by
About this trial
This is an interventional treatment trial for Problem Drinking focused on measuring problem drinking, randomized control trial, Pamphlet-based personalized alcohol feedback (PAF)
Eligibility Criteria
Inclusion Criteria:
- Age 19 years or more
- Audit score of 8 or more (the AUDIT is a validated screener, developed by WHO, to identify problem drinkers in the community and health-care settings)
Sites / Locations
- Stanford University School of Medicine
- University of Washington
- University of Alberta
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
1
2
No intervention control
Arm Description
Outcomes
Primary Outcome Measures
frequency of alcohol consumption
alcoholic drinks per occasion
Secondary Outcome Measures
Full Information
NCT ID
NCT00688584
First Posted
May 30, 2008
Last Updated
April 8, 2013
Sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00688584
Brief Title
Ultra-brief Intervention for Problem Drinkers
Official Title
Ultra-brief Intervention for Problem Drinkers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects will be recruited via a telephone survey which will collect baseline data. The households of half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter. Follow-up interviews will be conducted, by telephone, three and six months after the mailing of the pamphlets.
Hypothesis 1: Respondents from households who receive the pamphlet will display significantly improved drinking outcomes at the three-month and six-month follow-ups as compared to respondents from households in the no intervention control condition.
Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and advertised elsewhere) from residents of households who receive the pamphlet as compared to residents from households who do not receive the pamphlet.
Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived risk, perceived drinking norms, and drinking for social reasons.
Detailed Description
How do we help those problem drinkers who will never seek treatment? This is a challenging issue because of the large number of problem drinkers and the limited amount of resources available. Public health initiatives employing educational materials have met with little or no success. However, clinical research has developed effective brief interventions to help problem drinkers. This project will merge these two worlds, modifying a clinically developed intervention and producing it in an ultra-brief format that is suitable for use as a public health intervention. The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention for problem drinkers. The advantages of the personalized feedback pamphlet are that it is low cost and can be widely distributed to the population of problem drinkers who never seek treatment. Because the materials are based on some of the best of research-based interventions, such an ultra-brief normative feedback pamphlet has the potential of helping problem drinkers. An effective intervention of this type would yield significant public health benefit. 1830 problem drinkers will be recruited on a baseline population telephone survey and randomized to one of three conditions - personalized feedback pamphlet condition, control pamphlet condition (to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet) and a no intervention control condition (sent intervention pamphlet after the six-month follow-up). In the week after the baseline survey, all households in the postal code areas that contain respondents in the two pamphlet conditions will be sent their respective pamphlets. Changes in drinking will be assessed on post intervention three-month and six-month follow-ups. Drinking outcomes will be compared between experimental conditions. The primary hypothesis is that respondents from households who receive the personalized feedback pamphlet intervention will display significantly improved drinking outcomes at three and six-month follow-ups as compared to respondents from households in the no intervention control condition. Secondary hypotheses will test the impact of the intervention on help seeking, and explore the mediating or moderating role of perceived drinking norms, perceived risk and the problem drinker's social reasons for drinking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Drinking, Alcoholism
Keywords
problem drinking, randomized control trial, Pamphlet-based personalized alcohol feedback (PAF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1767 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
No intervention control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Pamphlet-based personalized alcohol feedback (PAF)
Intervention Description
participants in this condition will be mailed their respective pamphlets
Intervention Type
Behavioral
Intervention Name(s)
control pamphlet condition
Intervention Description
The goal is to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet.
Primary Outcome Measure Information:
Title
frequency of alcohol consumption
Time Frame
measured at 3 and 6 months into the study
Title
alcoholic drinks per occasion
Time Frame
measured at 3 and 6 months into the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 19 years or more
Audit score of 8 or more (the AUDIT is a validated screener, developed by WHO, to identify problem drinkers in the community and health-care settings)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Cunningham, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105-6099
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2H1
Country
Canada
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23110157
Citation
Cunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: results from a randomized controlled trial. PLoS One. 2012;7(10):e48003. doi: 10.1371/journal.pone.0048003. Epub 2012 Oct 24.
Results Reference
derived
PubMed Identifier
18727823
Citation
Cunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: research protocol. BMC Public Health. 2008 Aug 26;8:298. doi: 10.1186/1471-2458-8-298.
Results Reference
derived
Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health
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