Problem DrinkingNCT00688584
Ultra-brief Intervention for Problem Drinkers
A study testing Pamphlet-based personalized alcohol feedback (PAF) in people with Problem Drinking and Alcoholism, run by Centre for Addiction and Mental Health at 4 sites in 2 countries.
Trial summary
The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects will be recruited via a telephone survey which will collect baseline data. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Problem Drinking, Alcoholism
- What is being tested?
- Pamphlet-based personalized alcohol feedback (PAF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,767 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2008to Dec 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
- Age 19 years or more
- Audit score of 8 or more (the AUDIT is a validated screener, developed by WHO, to identify problem drinkers in the community and health-care settings)
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
University of Washington
Seattle, Washington, 98105-6099
Stanford University School of Medicine
Stanford, California, 94305
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 2H1
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects will be recruited via a telephone survey which will collect baseline data. The households of half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter. Follow-up interviews will be conducted, by telephone, three and six months after the mailing of the pamphlets.
Hypothesis 1: Respondents from households who receive the pamphlet will display significantly improved drinking outcomes at the three-month and six-month follow-ups as compared to respondents from households in the no intervention control condition.
Read more
Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and advertised elsewhere) from residents of households who receive the pamphlet as compared to residents from households who do not receive the pamphlet.
Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived risk, perceived drinking norms, and drinking for social reasons.
Read the detailed description
How do we help those problem drinkers who will never seek treatment? This is a challenging issue because of the large number of problem drinkers and the limited amount of resources available. Public health initiatives employing educational materials have met with little or no success. However, clinical research has developed effective brief interventions to help problem drinkers. This project will merge these two worlds, modifying a clinically developed intervention and producing it in an ultra-brief format that is suitable for use as a public health intervention. The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention for problem drinkers. The advantages of the personalized feedback pamphlet are that it is low cost and can be widely distributed to the population of problem drinkers who never seek treatment. Because the materials are based on some of the best of research-based interventions, such an ultra-brief normative feedback pamphlet has the potential of helping problem drinkers. An effective intervention of this type would yield significant public health benefit. 1830 problem drinkers will be recruited on a baseline population telephone survey and randomized to one of three conditions - personalized feedback pamphlet condition, control pamphlet condition (to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet) and a no intervention control condition (sent intervention pamphlet after the six-month follow-up). In the week after the baseline survey, all households in the postal code areas that contain respondents in the two pamphlet conditions will be sent their respective pamphlets. Changes in drinking will be assessed on post intervention three-month and six-month follow-ups. Drinking outcomes will be compared between experimental conditions. The primary hypothesis is that respondents from households who receive the personalized feedback pamphlet intervention will display significantly improved drinking outcomes at three and six-month follow-ups as compared to respondents from households in the no intervention control condition. Secondary hypotheses will test the impact of the intervention on help seeking, and explore the mediating or moderating role of perceived drinking norms, perceived risk and the problem drinker's social reasons for drinking.
- Conditions
- Problem Drinking, Alcoholism
- Being tested
- Pamphlet-based personalized alcohol feedback (PAF), control pamphlet condition
- Keywords
- problem drinking, randomized control trial, Pamphlet-based personalized alcohol feedback (PAF)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pamphlet-based personalized alcohol feedback (PAF)Behavioural
participants in this condition will be mailed their respective pamphlets
control pamphlet conditionBehavioural
The goal is to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Pamphlet-based personalized alcohol feedback (PAF) |
| 2 | Placebo comparator | Not described Receives: Behavioral: control pamphlet condition |
| No intervention control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of alcohol consumption
Measured: measured at 3 and 6 months into the study
alcoholic drinks per occasion
Measured: measured at 3 and 6 months into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionDec 2010
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 Problem DrinkingStudies 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
- None (open label)
- Enrolment
- 1,767 participants (actual)
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)
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John Cunningham, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688584
- Sponsor's protocol ID
- 301/2006
- Status last verified
- Apr 2013
- First submitted
- 30 May 2008
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: results from a randomized controlled trial. PLoS One. 2012;7(10):e48003. doi: 10.1371/journal.pone.0048003. Epub 2012 Oct 24.
PubMed 23110157Cunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: research protocol. BMC Public Health. 2008 Aug 26;8:298. doi: 10.1186/1471-2458-8-298.
PubMed 18727823
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-brief Intervention for Problem Drinkers
- ClinicalTrials.gov ID
- NCT00688584
- Acronym / sponsor ID
- 301/2006
- Conditions
- Problem Drinking, Alcoholism
- Keywords
- problem drinking, randomized control trial, Pamphlet-based personalized alcohol feedback (PAF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,767 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jun 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 major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects will be recruited via a telephone survey which will collect baseline data. The households of half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter. Follow-up interviews will be conducted, by telephone, three and six months after the mailing of the pamphlets.
Hypothesis 1: Respondents from households who receive the pamphlet will display significantly improved drinking outcomes at the three-month and six-month follow-ups as compared to respondents from households in the no intervention control condition.
Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and advertised elsewhere) from residents of households who receive the pamphlet as compared to residents from households who do not receive the pamphlet.
Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived risk, perceived drinking norms, and drinking for social reasons.
Detailed description
How do we help those problem drinkers who will never seek treatment? This is a challenging issue because of the large number of problem drinkers and the limited amount of resources available. Public health initiatives employing educational materials have met with little or no success. However, clinical research has developed effective brief interventions to help problem drinkers. This project will merge these two worlds, modifying a clinically developed intervention and producing it in an ultra-brief format that is suitable for use as a public health intervention. The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention for problem drinkers. The advantages of the personalized feedback pamphlet are that it is low cost and can be widely distributed to the population of problem drinkers who never seek treatment. Because the materials are based on some of the best of research-based interventions, such an ultra-brief normative feedback pamphlet has the potential of helping problem drinkers. An effective intervention of this type would yield significant public health benefit. 1830 problem drinkers will be recruited on a baseline population telephone survey and randomized to one of three conditions - personalized feedback pamphlet condition, control pamphlet condition (to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet) and a no intervention control condition (sent intervention pamphlet after the six-month follow-up). In the week after the baseline survey, all households in the postal code areas that contain respondents in the two pamphlet conditions will be sent their respective pamphlets. Changes in drinking will be assessed on post intervention three-month and six-month follow-ups. Drinking outcomes will be compared between experimental conditions. The primary hypothesis is that respondents from households who receive the personalized feedback pamphlet intervention will display significantly improved drinking outcomes at three and six-month follow-ups as compared to respondents from households in the no intervention control condition. Secondary hypotheses will test the impact of the intervention on help seeking, and explore 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
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Pamphlet-based personalized alcohol feedback (PAF) |
| 2 | Placebo comparator | Behavioral: control pamphlet condition |
| No intervention control | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 19 years or more
- Audit score of 8 or more (the AUDIT is a validated screener, developed by WHO, to identify problem drinkers in the community and health-care settings)
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 |
|---|---|---|
| Pamphlet-based personalized alcohol feedback (PAF)participants in this condition will be mailed their respective pamphlets | Behavioural | 1 |
| control pamphlet conditionThe goal is to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet. | Behavioural | 2 |
Primary outcome
frequency of alcohol consumption
Time frame: measured at 3 and 6 months into the study
alcoholic drinks per occasion
Time frame: measured at 3 and 6 months into the study
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 9 Apr 2013.
- Derived from this study: PubMed 23110157Cunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: results from a randomized controlled trial. PLoS One. 2012;7(10):e48003. doi: 10.1371/journal.pone.0048003. Epub 2012 Oct 24.
- Derived from this study: PubMed 18727823Cunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: research protocol. BMC Public Health. 2008 Aug 26;8:298. doi: 10.1186/1471-2458-8-298.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pamphlet-based personalized alcohol feedback (PAF) in people with Problem Drinking and Alcoholism, run by Centre for Addiction and Mental Health at 4 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 2 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 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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. 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.
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 alcohol consumption (time frame: measured at 3 and 6 months into the study). The study lists 2 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 NCT00688584, 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 9 Apr 2013.