Alcohol ConsumptionNCT01874509
Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers
A study testing Check Your Drinking and Alcohol Help Centre in people with Alcohol Consumption and Hazardous Alcohol Consumption, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Consumption, Hazardous Alcohol Consumption
- What is being tested?
- Check Your Drinking and Alcohol Help Centre
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Feb 2016
- 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 of age or over
- 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 month, twelve month and 2 year intervals
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings.
One promising strategy is Internet-based interventions for problem drinkers. The first randomized controlled trial found that the investigators could reduce alcohol consumption by about six drinks per week at a six-month follow-up using a minimal, personalized feedback Internet-based intervention. The investigators second randomized trial demonstrated that an extended Internet-based intervention that contained a range of cognitive-behavioural and relapse prevention tools could produce greater reductions in problem drinking compared to that provided by the same minimal intervention at a six-month follow-up. Building upon this research, the current project will assess whether this extended Internet-based intervention can have a sustained impact on problem drinking. Specifically, the major objective of this project is to conduct a randomized controlled trial comparing the impact of an extended Internet-based self-help intervention for problem drinkers to a minimal Internet-based intervention in the general population of problem drinkers over a two year period.
Problem drinking participants will be recruited through media advertisements across Canada and will be randomly assigned to the minimal or extended Internet-based interventions. Six-month, twelve-month and two-year drinking outcomes will be compared between experimental conditions. It is predicted that participants receiving the extended Internet intervention will display sustained improved drinking outcomes compared to participants in the minimal Internet intervention condition. This programmatic line of research will advance the science of Internet-mediated intervention.
- Conditions
- Alcohol Consumption, Hazardous Alcohol Consumption
- Being tested
- Check Your Drinking, Alcohol Help Centre
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Check Your DrinkingBehavioural
Alcohol Help CentreBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Check Your Drinking screener | Active comparator | 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. Receives: Behavioral: Check Your Drinking |
| Alcohol Help Centre | Experimental | 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. Receives: Behavioral: Alcohol Help Centre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AUDIT-C from baseline
A composite measure of three quantity/frequency drinking items (number of drinks per drinking day; frequency of alcohol consumption; frequency of 5+ drinking days). Developed by the world health organization.
Measured: 6 months, 1 year, 2 years
Secondary outcomes (2)
Change in number of drinks in a typical week from baseline
Sum of number of drinks consumed in a typical week
Measured: 6 months, 1 year, 2 years
Change in highest number of drinks on one occasion from baseline
Greatest amount drunk on one occasion
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John A Cunningham, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874509
- Sponsor's protocol ID
- CFP 285651
- Status last verified
- Mar 2017
- First submitted
- 7 Jun 2013
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cunningham JA, Shorter GW, Murphy M, Kushnir V, Rehm J, Hendershot CS. Randomized Controlled Trial of a Brief Versus Extended Internet Intervention for Problem Drinkers. Int J Behav Med. 2017 Oct;24(5):760-767. doi: 10.1007/s12529-016-9604-5.
PubMed 27770293Cunningham JA, Hendershot CS, Rehm J. Randomized controlled trial of a minimal versus extended Internet-based intervention for problem drinkers: study protocol. BMC Public Health. 2015 Jan 21;15:21. doi: 10.1186/s12889-015-1347-8.
PubMed 25604206
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers
- ClinicalTrials.gov ID
- NCT01874509
- Acronym / sponsor ID
- CFP 285651
- Conditions
- Alcohol Consumption, Hazardous Alcohol Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Jun 2013 (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.
Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings.
One promising strategy is Internet-based interventions for problem drinkers. The first randomized controlled trial found that the investigators could reduce alcohol consumption by about six drinks per week at a six-month follow-up using a minimal, personalized feedback Internet-based intervention. The investigators second randomized trial demonstrated that an extended Internet-based intervention that contained a range of cognitive-behavioural and relapse prevention tools could produce greater reductions in problem drinking compared to that provided by the same minimal intervention at a six-month follow-up. Building upon this research, the current project will assess whether this extended Internet-based intervention can have a sustained impact on problem drinking. Specifically, the major objective of this project is to conduct a randomized controlled trial comparing the impact of an extended Internet-based self-help intervention for problem drinkers to a minimal Internet-based intervention in the general population of problem drinkers over a two year period.
Problem drinking participants will be recruited through media advertisements across Canada and will be randomly assigned to the minimal or extended Internet-based interventions. Six-month, twelve-month and two-year drinking outcomes will be compared between experimental conditions. It is predicted that participants receiving the extended Internet intervention will display sustained improved drinking outcomes compared to participants in the minimal Internet intervention condition. This programmatic line of research will advance the science of Internet-mediated intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Check Your Drinking screener | Active comparator | Behavioral: Check Your DrinkingInternet 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 | Experimental | Behavioral: Alcohol Help CentreInternet 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or over
- 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 month, twelve month and 2 year intervals
Key exclusion criteria (1 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 |
|---|---|---|
| Check Your Drinking | Behavioural | Check Your Drinking screener |
| Alcohol Help Centre | Behavioural | Alcohol Help Centre |
Primary outcome
Change in AUDIT-C from baseline
Time frame: 6 months, 1 year, 2 years
A composite measure of three quantity/frequency drinking items (number of drinks per drinking day; frequency of alcohol consumption; frequency of 5+ drinking days). Developed by the world health organization.
2 secondary outcomes
Change in number of drinks in a typical week from baseline
Time frame: 6 months, 1 year, 2 years
Change in highest number of drinks on one occasion from baseline
Time frame: 6 months, 1 year, 2 years
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 28 Mar 2017.
- Derived from this study: PubMed 27770293Cunningham JA, Shorter GW, Murphy M, Kushnir V, Rehm J, Hendershot CS. Randomized Controlled Trial of a Brief Versus Extended Internet Intervention for Problem Drinkers. Int J Behav Med. 2017 Oct;24(5):760-767. doi: 10.1007/s12529-016-9604-5.
- Derived from this study: PubMed 25604206Cunningham JA, Hendershot CS, Rehm J. Randomized controlled trial of a minimal versus extended Internet-based intervention for problem drinkers: study protocol. BMC Public Health. 2015 Jan 21;15:21. doi: 10.1186/s12889-015-1347-8.
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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, Ph.D. 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 and Alcohol Help Centre in people with Alcohol Consumption and Hazardous Alcohol Consumption, 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 5 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 28 Mar 2017. 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?
Change in AUDIT-C from baseline (time frame: 6 months, 1 year, 2 years). 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 NCT01874509, which also lists 2 linked publications.
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 28 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.