Alcohol AbusePhase 3NCT00728767
Brief Intervention for Heavy Drinkers
A Phase 3 study testing Brief intervention in people with Alcohol Abuse, run by University of Southern Denmark at 9 sites in Denmark.
Trial summary
The purpose of the study is to determine whether a brief intervention (a short conversation build on the principles of motivational interviewing) is effective in lowering self reported alcohol use in heavy drinkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Brief intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 772 participants
- Where
- 9 sitesDenmark
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 3
- 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
- Participants must be invited to the Danish 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
- Participants must have responded to an Internet questionnaire.
- Participants must have a weekly alcohol consumption above the recommended Danish limits (168 grams of alcohol for women, 252 grams of alcohol for men).
Who cannot join
- Weekly alcohol consumption less than 168 grams of alcohol for women and 252 grams of alcohol for men.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
The municipiality of Aeroe
Aeroeskoebing, 5970
The municipiality of Albertslund
Albertslund, 2620
The municipiality of Broendby
Brøndby, 2605
The municipiality of Frederiksberg
Frederiksberg, 2000
The municipality of Naestved
Næstved, Næstved, 4700
The municipality of Guldborgsund
Nykøbing Falster, 4800
The municipiality of Faaborg-Midtfyn
Ringe, 5750
The municipiality of Silkeborg
Silkeborg, 8600
The municipiality of Varde
Varde, 6800
About this study
Official title: Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial
The purpose of the study is to determine whether a brief intervention (a short conversation build on the principles of motivational interviewing) is effective in lowering self reported alcohol use in heavy drinkers.
Read the detailed description
Background and purpose:
The Danish national board of Health has awarded 5.6 million DKR to two studies that will test methods that can be used for effective and early detection of heavy drinkers. The study will be carried out in 9 Danish municipalities in 2008. The study is part of the 'Diet, Smoking, Alcohol and Exercise' nationwide health study of the Danish population. It takes place in 13 municipalities in 2007 and 2008.
The study will determine whether a brief intervention is effective in lowering self reported alcohol use in heavy drinkers.
Design:
The experiment is designed as a randomized controlled trial, where heavy drinkers will be allocated to either:
- a intervention group receiving a short (about 10 minutes) motivational conversation (build on the principles of motivational interviewing) and two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities. The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking.
- a control group receiving two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities.
The study will take place in premises linked to the 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
After 6 and 12 months there will be follow-up and the participants will receive a questionnaire with questions about their alcohol consumption.
- Conditions
- Alcohol Abuse
- Being tested
- Brief intervention, Control group
- Keywords
- Heavy drinking, Brief intervention, Alcohol prevention, Randomized trial, Motivational interviewing, Intervention Studies, prevention & control
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionOther
The intervention consists of a brief conversation based on the principles of motivational interviewing, including Rollnicks scales to assess the motivation and importance for change. The intervention has duration of about 10 minutes and qualifies as a hybrid between a minimal intervention and a brief intervention.
The intervention also consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol above recommended limits, and a sheet about local alcohol treatment possibilities.
The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking.
Employees had been instructed to ask these questions during the intervention: "What are you already doing to restrain your drinking?" And "What can you do more?"
Control groupOther
The intervention consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol use above the recommended limits, and a sheet about local alcohol treatment possibilities.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Brief intervention |
| 2 | Placebo comparator | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent.
Measured: 6 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 posted6 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionDec 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 Alcohol AbuseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 772 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Health, Denmark
- Investigators
- Anders B. Gottlieb Hansen, cand.techn.soc, Principal investigator, University of Southern Denmark, National Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728767
- Sponsor's protocol ID
- NIPH - 1948
- Status last verified
- Aug 2009
- First submitted
- 1 Aug 2008
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansen AB, Becker U, Nielsen AS, Gronbaek M, Tolstrup JS. Brief alcohol intervention by newly trained workers versus leaflets: comparison of effect in older heavy drinkers identified in a population health examination survey: a randomized controlled trial. Alcohol Alcohol. 2012 Jan-Feb;47(1):25-32. doi: 10.1093/alcalc/agr140. Epub 2011 Sep 22.
PubMed 21949192
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00728767
- Acronym / sponsor ID
- NIPH - 1948
- Conditions
- Alcohol Abuse
- Keywords
- Heavy drinking, Brief intervention, Alcohol prevention, Randomized trial, Motivational interviewing, Intervention Studies, prevention & control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 772 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- National Board of Health, Denmark
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Aug 2008 (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 purpose of the study is to determine whether a brief intervention (a short conversation build on the principles of motivational interviewing) is effective in lowering self reported alcohol use in heavy drinkers.
Detailed description
Background and purpose:
The Danish national board of Health has awarded 5.6 million DKR to two studies that will test methods that can be used for effective and early detection of heavy drinkers. The study will be carried out in 9 Danish municipalities in 2008. The study is part of the 'Diet, Smoking, Alcohol and Exercise' nationwide health study of the Danish population. It takes place in 13 municipalities in 2007 and 2008.
The study will determine whether a brief intervention is effective in lowering self reported alcohol use in heavy drinkers.
Design:
The experiment is designed as a randomized controlled trial, where heavy drinkers will be allocated to either:
- a intervention group receiving a short (about 10 minutes) motivational conversation (build on the principles of motivational interviewing) and two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities. The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking.
- a control group receiving two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities.
The study will take place in premises linked to the 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
After 6 and 12 months there will be follow-up and the participants will receive a questionnaire with questions about their alcohol consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Brief intervention |
| 2 | Placebo comparator | Other: Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be invited to the Danish 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
- Participants must have responded to an Internet questionnaire.
- Participants must have a weekly alcohol consumption above the recommended Danish limits (168 grams of alcohol for women, 252 grams of alcohol for men).
Key exclusion criteria (1 listed)
- Weekly alcohol consumption less than 168 grams of alcohol for women and 252 grams of alcohol for men.
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 |
|---|---|---|
| Brief interventionThe intervention consists of a brief conversation based on the principles of motivational interviewing, including Rollnicks scales to assess the motivation and importance for change. The intervention has duration of about 10 minutes and qualifies as a hybrid between a minimal intervention and a brief intervention. The intervention also consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol above recommended limits, and a sheet about local alcohol treatment possibilities. The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking. Employees had been instructed to ask these questions during the intervention: "What are you already doing to restrain your drinking?" And "What can you do more?" | Other | 1 |
| Control groupThe intervention consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol use above the recommended limits, and a sheet about local alcohol treatment possibilities. | Other | 2 |
Primary outcome
Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent.
Time frame: 6 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 14 Apr 2011.
- Derived from this study: PubMed 21949192Hansen AB, Becker U, Nielsen AS, Gronbaek M, Tolstrup JS. Brief alcohol intervention by newly trained workers versus leaflets: comparison of effect in older heavy drinkers identified in a population health examination survey: a randomized controlled trial. Alcohol Alcohol. 2012 Jan-Feb;47(1):25-32. doi: 10.1093/alcalc/agr140. Epub 2011 Sep 22.
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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.
Anders B. Gottlieb Hansen, cand.techn.soc principal investigator
University of Southern Denmark, National Institute of Public Health
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brief intervention in people with Alcohol Abuse, run by University of Southern Denmark at 9 sites in Denmark.
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 3 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 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent. (time frame: 6 and 12 months). 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 NCT00728767, 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 14 Apr 2011.