AlcoholismNCT00367575
An Internet-based Intervention for Problem Drinking
A study testing Internet personalized alcohol feedback (PAF) in people with Alcoholism, run by Centre for Addiction and Mental Health at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Internet personalized alcohol feedback (PAF)
- Type of treatment
- Surgery or procedure
- How many people
- 359 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
University of Alberta
Edmonton, Alberta
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1
United States1 site
Stanford University School of Medicine
Stanford, California
About this study
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.
Read the 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.
- Conditions
- Alcoholism
- Being tested
- Internet personalized alcohol feedback (PAF)
- Keywords
- alcoholism, drinking, randomized, internet personalized alcohol feedback
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet personalized alcohol feedback (PAF)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of consumption
drinks per occasion
number of drinks in a typical week
frequency of 5+ consumption
highest number of drinks on one occasion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startSep 2006
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 359 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- John A Cunningham, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367575
- Sponsor's protocol ID
- 053/2005
- Status last verified
- Aug 2010
- First submitted
- 21 Aug 2006
- Last updated
- 16 Aug 2010
- Results posted
- No
Publications
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.
PubMed 20150170
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-based Intervention for Problem Drinking
- ClinicalTrials.gov ID
- NCT00367575
- Acronym / sponsor ID
- 053/2005
- Conditions
- Alcoholism
- Keywords
- alcoholism, drinking, randomized, internet personalized alcohol feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2006
- Study completion
- Sep 2009
- First posted
- 23 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet personalized alcohol feedback (PAF) | Procedure or surgery | – |
Primary outcome
frequency of consumption
drinks per occasion
number of drinks in a typical week
frequency of 5+ consumption
highest number of drinks on one occasion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
- Derived from this study: PubMed 20150170Cunningham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Cunningham, PhD principal investigator
Centre for Addiction and Mental Health
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet personalized alcohol feedback (PAF) in people with Alcoholism, run by Centre for Addiction and Mental Health at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of consumption. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00367575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2010.