Alcohol DependenceNCT01114919
Helping Problem Drinkers on the Internet
A study testing Check Your Drinking (CYD) and Alcohol Help Centre (AHC) in people with Alcohol Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The main aim of this study is to compare the impact of a minimal and a full Internet-based self-help intervention for problem drinkers in the general population. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Check Your Drinking (CYD) and Alcohol Help Centre (AHC)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 246 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Nov 2010
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of Ontario
- 19 years of age or over
- Have consumed alcohol in the one month prior to the telephone survey.
- Have consumed alcohol in the one month prior to the telephone survey.
- A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
- Indicate an interest in receiving self-help materials
- Have home access to the Internet
- Are willing to participate in follow-up at six and twelve month intervals
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this study is to compare the impact of a minimal and a full Internet-based self-help intervention for problem drinkers in the general population.
Read the detailed description
Many problem drinkers never access any treatment services. Because of the individual as well as societal costs of heavy alcohol consumption, it is essential to find ways to intervene and provide assistance to problem drinkers. The Internet takes treatment to problem drinkers rather than requiring them to come to treatment, resulting in increased options for help for alcohol abusers. There is a preponderance of internet websites which are designed for self change in areas that include alcohol use. To date, however, there has been minimal scientific evaluation regarding the efficacy and safety of such programs.
Our own previous research found that we could reduce alcohol consumption by about three drinks per week at a six-month follow-up using a minimal, personalized feedback Internet-based intervention. Building on this, the current project will attempt to increase the impact of Internet-based interventions as well as produce sustained reductions in drinking by adding an extended online self-help service to this already promising minimal intervention. More specifically, this randomized, double blinded study will compare and evaluate the efficacy of two different degrees of treatment intervention for problem drinkers: a minimal one ("Check your Drinking") and a full one ("Alcohol Help Centre").
- Conditions
- Alcohol Dependence
- Being tested
- Check Your Drinking (CYD), Alcohol Help Centre (AHC)
- Keywords
- Problem drinking, Alcohol dependence, Alcohol abuse, Internet based intervention, Treatment, Alcohol Use Disorders Identification Test
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Check Your Drinking (CYD)Behavioural
Internet based program of lower intensity as compared to the "Alcohol Help Centre. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding abstinence.
Alcohol Help Centre (AHC)Behavioural
Internet based program of higher intensity as compared to the "Check Your Drinking" intervention. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding abstinence.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of consumption
Measured: 6 months and 12 months
Usual number of drinks per occasion
Measured: 6 months and 12 months
Frequency of consuming 5 or more drinks on one occasion
Measured: 6 months and 12 months
Typical weekly consumption
Measured: 6 months and 12 months
Highest number of drinks on one occasion
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010
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 Alcohol DependenceStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Health Canada
- Investigators
- John Cunningham, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114919
- Sponsor's protocol ID
- 282/2009
- Status last verified
- Dec 2010
- First submitted
- 30 Apr 2010
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Cunningham JA. Comparison of two internet-based interventions for problem drinkers: randomized controlled trial. J Med Internet Res. 2012 Aug 1;14(4):e107. doi: 10.2196/jmir.2090.
PubMed 22954459
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Problem Drinkers on the Internet
- ClinicalTrials.gov ID
- NCT01114919
- Acronym / sponsor ID
- 282/2009
- Conditions
- Alcohol Dependence
- Keywords
- Problem drinking, Alcohol dependence, Alcohol abuse, Internet based intervention, Treatment, Alcohol Use Disorders Identification Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Health Canada
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- First posted
- 3 May 2010 (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 study is to compare the impact of a minimal and a full Internet-based self-help intervention for problem drinkers in the general population.
Detailed description
Many problem drinkers never access any treatment services. Because of the individual as well as societal costs of heavy alcohol consumption, it is essential to find ways to intervene and provide assistance to problem drinkers. The Internet takes treatment to problem drinkers rather than requiring them to come to treatment, resulting in increased options for help for alcohol abusers. There is a preponderance of internet websites which are designed for self change in areas that include alcohol use. To date, however, there has been minimal scientific evaluation regarding the efficacy and safety of such programs.
Our own previous research found that we could reduce alcohol consumption by about three drinks per week at a six-month follow-up using a minimal, personalized feedback Internet-based intervention. Building on this, the current project will attempt to increase the impact of Internet-based interventions as well as produce sustained reductions in drinking by adding an extended online self-help service to this already promising minimal intervention. More specifically, this randomized, double blinded study will compare and evaluate the efficacy of two different degrees of treatment intervention for problem drinkers: a minimal one ("Check your Drinking") and a full one ("Alcohol Help Centre").
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Resident of Ontario
- 19 years of age or over
- Have consumed alcohol in the one month prior to the telephone survey.
- Have consumed alcohol in the one month prior to the telephone survey.
- A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Check Your Drinking (CYD)Internet based program of lower intensity as compared to the "Alcohol Help Centre. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding abstinence. | Behavioural | – |
| Alcohol Help Centre (AHC)Internet based program of higher intensity as compared to the "Check Your Drinking" intervention. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding abstinence. | Behavioural | – |
Primary outcome
Frequency of consumption
Time frame: 6 months and 12 months
Usual number of drinks per occasion
Time frame: 6 months and 12 months
Frequency of consuming 5 or more drinks on one occasion
Time frame: 6 months and 12 months
Typical weekly consumption
Time frame: 6 months and 12 months
Highest number of drinks on one occasion
Time frame: 6 months and 12 months
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 2 Dec 2010.
- Derived from this study: PubMed 22954459Cunningham JA. Comparison of two internet-based interventions for problem drinkers: randomized controlled trial. J Med Internet Res. 2012 Aug 1;14(4):e107. doi: 10.2196/jmir.2090.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre.Link provided by the sponsor.
Related trials for Alcohol Dependence
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SMART-r: Substance Monitoring and Active Relapse Tracking Repository
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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 Cunningham, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Check Your Drinking (CYD) and Alcohol Help Centre (AHC) in people with Alcohol Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 8 inclusion and 1 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 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 (time frame: 6 months and 12 months). 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 NCT01114919, 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 2 Dec 2010.