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An Internet-based Intervention for Problem Drinking

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Internet personalized alcohol feedback (PAF)
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring alcoholism, drinking, randomized, internet personalized alcohol feedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years or older have home access to the Internet interested in receiving a computerized assessment of their drinking have a score of 8 or higher on the AUDIT.

Sites / Locations

  • Stanford University School of Medicine
  • University of Alberta
  • Centre for Addiction and Mental Health

Outcomes

Primary Outcome Measures

frequency of consumption
drinks per occasion
number of drinks in a typical week
frequency of 5+ consumption
highest number of drinks on one occasion.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2006
Last Updated
August 13, 2010
Sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00367575
Brief Title
An Internet-based Intervention for Problem Drinking
Official Title
An Internet-based Intervention for Problem Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary
The main aim of this randomized controlled trial is to evaluate the efficacy of an Internet-delivered self-help intervention for problem drinkers in the general population. Adult problem drinkers with home access to the Internet will be recruited from the CAMH Monitor. Subjects will be randomly assigned to receive a website address where they can obtain personalized feedback about their drinking, or to a no intervention control group. Three-month and six-month follow-up surveys will be conducted by mail to assess drinking over the following three month periods. Collaterals will be requested and interviewed after the six-month follow-up. Subjects will be paid $40.00 and collaterals will be paid $20.00 for their participation. Drinking at three- and six-months will be compared between the groups. Subjects in the control group will be provided with the website address following the six-month follow-up.
Detailed Description
Self-change interventions have great potential to aid the many problem drinkers who do not seek formal treatment. Because self-change interventions circumvent some of the barriers associated with traditional treatment services, they may help reduce the harm associated with alcohol abuse among untreated individuals, whose number far exceeds that of the minority who ever access formal alcohol treatment programs. Self-change/self-help materials have the added advantage of being relatively inexpensive, increasing their potential for wide distribution and attendant public health impact. The Internet is one promising route for distributing such materials to a large segment of the population. Three-quarters of Canadians and Americans use the Internet, including a large number who seek health-related information on line. Drinking self-change websites abound on the Internet, but because none has been scientifically evaluated it is unknown whether such sites do more good than harm. By being the first large scale, controlled evaluation, this project intends to advance the science of Internet-mediated intervention as well as provide valuable public health information on the effectiveness of Internet-delivered self-change materials. Specifically, the major objective of this project is to conduct a randomized controlled evaluation of the impact of an Internet-based self-help intervention for problem drinkers in the general population. Participants will be recruited through the ongoing general population survey - the CAMH Monitor (N = 170 after attrition), and will be randomly assigned to be sent a World Wide Web page Internet address and password for the personalized alcohol feedback program or to a no intervention control group. Three and six-month drinking outcomes will be compared between experimental conditions using structural equation modeling. The primary hypothesis is that respondents in the Internet personalized alcohol feedback condition will display significantly improved drinking outcomes at three and six-month follow-ups as compared to respondents in the no intervention control condition. Secondary hypotheses will address 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
Alcoholism
Keywords
alcoholism, drinking, randomized, internet personalized alcohol feedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
359 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Internet personalized alcohol feedback (PAF)
Primary Outcome Measure Information:
Title
frequency of consumption
Title
drinks per occasion
Title
number of drinks in a typical week
Title
frequency of 5+ consumption
Title
highest number of drinks on one occasion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older have home access to the Internet interested in receiving a computerized assessment of their drinking have a score of 8 or higher on the AUDIT.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A 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
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20150170
Citation
Cunningham JA, Wild TC, Cordingley J, Van Mierlo T, Humphreys K. Twelve-month follow-up results from a randomized controlled trial of a brief personalized feedback intervention for problem drinkers. Alcohol Alcohol. 2010 May-Jun;45(3):258-62. doi: 10.1093/alcalc/agq009. Epub 2010 Feb 10.
Results Reference
derived

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An Internet-based Intervention for Problem Drinking

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