Ultra-brief Intervention for Problem Drinkers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Cunningham, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00688584
First received: May 30, 2008
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Problem Drinking
Alcoholism
Behavioral: Pamphlet-based personalized alcohol feedback (PAF)
Behavioral: control pamphlet condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultra-brief Intervention for Problem Drinkers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • frequency of alcohol consumption [ Time Frame: measured at 3 and 6 months into the study ] [ Designated as safety issue: No ]
  • alcoholic drinks per occasion [ Time Frame: measured at 3 and 6 months into the study ] [ Designated as safety issue: No ]

Enrollment: 1767
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Pamphlet-based personalized alcohol feedback (PAF)
participants in this condition will be mailed their respective pamphlets
Placebo Comparator: 2 Behavioral: control pamphlet condition
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.
No Intervention: No intervention control

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688584

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Washington
University of Washington
Seattle, Washington, United States, 98105-6099
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2H1
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: John Cunningham, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided by Centre for Addiction and Mental Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Cunningham, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00688584     History of Changes
Other Study ID Numbers: 301/2006
Study First Received: May 30, 2008
Last Updated: April 8, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
problem drinking
randomized control trial
Pamphlet-based personalized alcohol feedback (PAF)

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

ClinicalTrials.gov processed this record on August 28, 2014