Problem DrinkingNCT01608763
What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial
A study testing Check Your Drinking (CYD) personalized feedback intervention in people with Problem Drinking, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The major objective of this project is to conduct a randomized controlled trial comparing the impact of the normative feedback and other personalized feedback components of the Check Your Drinking (CYD) Internet-based intervention in the general population. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Problem Drinking
- What is being tested?
- Check Your Drinking (CYD) personalized feedback intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Sep 2013
- 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
- problem drinkers as measured by an AUDIT score of 8 or more
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The major objective of this project is to conduct a randomized controlled trial comparing the impact of the normative feedback and other personalized feedback components of the Check Your Drinking (CYD) Internet-based intervention in the general population. Eligible problem drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design - to receive just the normative feedback component of the CYD intervention, just the other personalized feedback information, to a no intervention control condition, or to receive the full CYD intervention. The no intervention control condition will not be sent any intervention materials but will instead be sent a list of the different components of the CYD feedback and will be asked to think about how useful they would find each of them. All participants will be followed-up at 3 months.
- Conditions
- Problem Drinking
- Being tested
- Check Your Drinking (CYD) personalized feedback intervention
- 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) personalized feedback interventionBehavioural
The CYD provides problem drinkers with a personalized summary of their drinking that compares his or her drinking with that of the general population. The CYD also provides an assessment of the severity of the person's drinking problem.
| Study group | Role | What they receive |
|---|---|---|
| Full personalized feedback | Experimental | Participant provided with the full CYD personalized feedback summary. Receives: Behavioral: Check Your Drinking (CYD) personalized feedback intervention |
| Only normative feedback | Experimental | Participant provided with just the normative feedback component of the CYD personalized feedback summary. Receives: Behavioral: Check Your Drinking (CYD) personalized feedback intervention |
| Just other personalized feedback | Experimental | Participant provided with all the other personalized feedback components of the CYD intervention (i.e., no normative feedback). Receives: Behavioral: Check Your Drinking (CYD) personalized feedback intervention |
| No intervention control | No intervention | Participant provided with a list describing the components of the CYD intervention but not provided any personalized feedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks in a typical week
Number of drinks in a typical week
Measured: 3 months
AUDIT-C score
Composite measure of three drinking items - frequency of drinking, drinks per drinking day, frequency of 5+ drinking days
Measured: 3 months
Highest number of drinks on one occasion
Highest number of drinks on one occasion in the past 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionSep 2013
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 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John Cunningham, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608763
- Sponsor's protocol ID
- 001/2012
- Status last verified
- Dec 2014
- First submitted
- 28 May 2012
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cunningham JA, Murphy M, Hendershot CS. Treatment dismantling pilot study to identify the active ingredients in personalized feedback interventions for hazardous alcohol use: randomized controlled trial. Addict Sci Clin Pract. 2014 Dec 10;10(1):1. doi: 10.1186/s13722-014-0022-1.
PubMed 25539597
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01608763
- Acronym / sponsor ID
- 001/2012
- Conditions
- Problem Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 31 May 2012 (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 project is to conduct a randomized controlled trial comparing the impact of the normative feedback and other personalized feedback components of the Check Your Drinking (CYD) Internet-based intervention in the general population. Eligible problem drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design - to receive just the normative feedback component of the CYD intervention, just the other personalized feedback information, to a no intervention control condition, or to receive the full CYD intervention. The no intervention control condition will not be sent any intervention materials but will instead be sent a list of the different components of the CYD feedback and will be asked to think about how useful they would find each of them. All participants will be followed-up at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full personalized feedback | Experimental | Behavioral: Check Your Drinking (CYD) personalized feedback interventionParticipant provided with the full CYD personalized feedback summary. |
| Only normative feedback | Experimental | Behavioral: Check Your Drinking (CYD) personalized feedback interventionParticipant provided with just the normative feedback component of the CYD personalized feedback summary. |
| Just other personalized feedback | Experimental | Behavioral: Check Your Drinking (CYD) personalized feedback interventionParticipant provided with all the other personalized feedback components of the CYD intervention (i.e., no normative feedback). |
| No intervention control | No intervention | –Participant provided with a list describing the components of the CYD intervention but not provided any personalized feedback. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- problem drinkers as measured by an AUDIT score of 8 or more
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) personalized feedback interventionThe CYD provides problem drinkers with a personalized summary of their drinking that compares his or her drinking with that of the general population. The CYD also provides an assessment of the severity of the person's drinking problem. | Behavioural | Full personalized feedback, Just other personalized feedback, Only normative feedback |
Primary outcome
Drinks in a typical week
Time frame: 3 months
Number of drinks in a typical week
AUDIT-C score
Time frame: 3 months
Composite measure of three drinking items - frequency of drinking, drinks per drinking day, frequency of 5+ drinking days
Highest number of drinks on one occasion
Time frame: 3 months
Highest number of drinks on one occasion in the past 3 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 9 Dec 2014.
- Derived from this study: PubMed 25539597Cunningham JA, Murphy M, Hendershot CS. Treatment dismantling pilot study to identify the active ingredients in personalized feedback interventions for hazardous alcohol use: randomized controlled trial. Addict Sci Clin Pract. 2014 Dec 10;10(1):1. doi: 10.1186/s13722-014-0022-1.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teachingLink provided by the sponsor.
Related trials for Problem Drinking
Recruiting
Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms
Postpartum Depression (PPD), Alcohol Use
Recruiting
Greek Connections Study
Heavy Episodic Drinking, Problem Drinking
Not yet recruiting
Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence
Depression and Quality of Life, Sexual Violence
Active, not recruiting
Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault
Posttraumatic Stress Symptom, Alcohol Drinking
Recruiting
Reducing Blood Pressure in Mid-life Adult Binge Drinkers
Alcohol Drinking, Binge Drinking
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, 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 (CYD) personalized feedback intervention in people with Problem Drinking, 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 1 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 9 Dec 2014. 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?
Drinks in a typical week (time frame: 3 months). The study lists 3 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 NCT01608763, 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 9 Dec 2014; AzTrials last refreshed its copy on 30 Oct 2026.