Ultra-brief Intervention for Problem Drinkers

NCT ID: NCT00688584

Last Updated: 2013-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1767 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Problem Drinking Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Pamphlet-based personalized alcohol feedback (PAF)

Intervention Type BEHAVIORAL

participants in this condition will be mailed their respective pamphlets

2

Group Type PLACEBO_COMPARATOR

control pamphlet condition

Intervention Type BEHAVIORAL

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 control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pamphlet-based personalized alcohol feedback (PAF)

participants in this condition will be mailed their respective pamphlets

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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John Cunningham

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Cunningham, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 23110157 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18727823 (View on PubMed)

Related Links

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http://www.camh.net/research

Information about research at the Centre for Addiction and Mental Health

Other Identifiers

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301/2006

Identifier Type: -

Identifier Source: org_study_id

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