An Internet-based Intervention for Problem Drinking

Alcoholism Clinical Trial

Official title:

An Internet-based Intervention for Problem Drinking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367575
• Other study ID #: 053/2005
• Status: Completed
• Phase: N/A
• First received: August 21, 2006
• Last updated: August 13, 2010
• Start date: September 2006
• Est. completion date: September 2009

Study information

• Verified date: August 2010
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Procedure:
• Internet personalized alcohol feedback (PAF)

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of consumption
Primary	drinks per occasion
Primary	number of drinks in a typical week
Primary	frequency of 5+ consumption
Primary	highest number of drinks on one occasion.