Alcohol ConsumptionNCT03060135
Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption
A study testing Check Your Drinking and Hello Sunday Morning in people with Alcohol Consumption, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
There are a number of popular, freely available online interventions targeting hazardous alcohol consumption. Unfortunately, most have limited or no published evidence regarding their efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Check Your Drinking and Hello Sunday Morning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 878 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2017to 23 Oct 2017
- 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)
- Typically consumes 15 or more drinks per week,
- Willingness to complete a 6-month follow-up survey
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption: Randomized Controlled Trial
There are a number of popular, freely available online interventions targeting hazardous alcohol consumption. Unfortunately, most have limited or no published evidence regarding their efficacy. Of particular interest is the intervention, 'Hello Sunday Morning.' The current project proposes to evaluate its' efficacy employing a RCT, using The Check Your Drinking intervention as an active comparator in the trial.
Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who agree to be followed-up will be assigned by chance to be asked versus not asked to access one of the interventions and then recontacted 6 months later to ask about their drinking and their impressions of the online intervention. The primary hypothesis to be tested is that participants receiving access to any of the online interventions will report a greater level of reduction in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the control condition.
- Conditions
- Alcohol Consumption
- Being tested
- Check Your Drinking, Hello Sunday Morning
- 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
A anonymous brief survey designed to provide normative feedback of individual's drinking with the intent of motivating reductions in drinking
Hello Sunday MorningBehavioural
Brief online intervention that allows Individual's reflect on their drinking reductions progress and goals.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Control | No intervention | A questionnaire that asks individuals what components of an online intervention they might find useful. |
| Check Your Drinking (CYD) | Active comparator | The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking Receives: Behavioral: Check Your Drinking |
| Hello Sunday Morning | Experimental | Internet based program designed to assess drinking patterns, and support self-determined goals for abstinence, by providing users with an online platform and community to discuss progress and goals. Receives: Behavioral: Hello Sunday Morning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the variable, number of drinks in a typical week, from baseline measurement to 6-month follow-up
Sum of number of drinks consumed in a typical week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start24 Feb 2017
- Primary completion23 Oct 2017
- Study completion23 Oct 2017
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.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 878 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 A Cunningham, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060135
- Sponsor's protocol ID
- 11/13/2016
- Status last verified
- Oct 2017
- First submitted
- 17 Feb 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schell C, Godinho A, Cunningham JA. To thine own self, be true: Examining change in self-reported alcohol measures over time as related to socially desirable responding bias among people with unhealthy alcohol use. Subst Abus. 2021;42(1):87-93. doi: 10.1080/08897077.2019.1697998. Epub 2020 Feb 10.
PubMed 32040383Cunningham JA, Godinho A, Bertholet N. Outcomes of two randomized controlled trials, employing participants recruited through Mechanical Turk, of Internet interventions targeting unhealthy alcohol use. BMC Med Res Methodol. 2019 Jun 14;19(1):124. doi: 10.1186/s12874-019-0770-4.
PubMed 31200648
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03060135
- Acronym / sponsor ID
- 11/13/2016
- Conditions
- Alcohol Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 878 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
There are a number of popular, freely available online interventions targeting hazardous alcohol consumption. Unfortunately, most have limited or no published evidence regarding their efficacy. Of particular interest is the intervention, 'Hello Sunday Morning.' The current project proposes to evaluate its' efficacy employing a RCT, using The Check Your Drinking intervention as an active comparator in the trial.
Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who agree to be followed-up will be assigned by chance to be asked versus not asked to access one of the interventions and then recontacted 6 months later to ask about their drinking and their impressions of the online intervention. The primary hypothesis to be tested is that participants receiving access to any of the online interventions will report a greater level of reduction in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the control condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Control | No intervention | –A questionnaire that asks individuals what components of an online intervention they might find useful. |
| Check Your Drinking (CYD) | Active comparator | Behavioral: Check Your DrinkingThe CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking |
| Hello Sunday Morning | Experimental | Behavioral: Hello Sunday MorningInternet based program designed to assess drinking patterns, and support self-determined goals for abstinence, by providing users with an online platform and community to discuss progress and goals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or over
- A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
- Typically consumes 15 or more drinks per week,
- Willingness to complete a 6-month follow-up survey
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 |
|---|---|---|
| Check Your DrinkingA anonymous brief survey designed to provide normative feedback of individual's drinking with the intent of motivating reductions in drinking | Behavioural | Check Your Drinking (CYD) |
| Hello Sunday MorningBrief online intervention that allows Individual's reflect on their drinking reductions progress and goals. | Behavioural | Hello Sunday Morning |
Primary outcome
Change in the variable, number of drinks in a typical week, from baseline measurement to 6-month follow-up
Time frame: 6 months
Sum of number of drinks consumed in a typical week
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 25 Oct 2017.
- Derived from this study: PubMed 32040383Schell C, Godinho A, Cunningham JA. To thine own self, be true: Examining change in self-reported alcohol measures over time as related to socially desirable responding bias among people with unhealthy alcohol use. Subst Abus. 2021;42(1):87-93. doi: 10.1080/08897077.2019.1697998. Epub 2020 Feb 10.
- Derived from this study: PubMed 31200648Cunningham JA, Godinho A, Bertholet N. Outcomes of two randomized controlled trials, employing participants recruited through Mechanical Turk, of Internet interventions targeting unhealthy alcohol use. BMC Med Res Methodol. 2019 Jun 14;19(1):124. doi: 10.1186/s12874-019-0770-4.
- 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 CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, 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 and Hello Sunday Morning in people with 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 4 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 25 Oct 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 the variable, number of drinks in a typical week, from baseline measurement to 6-month follow-up (time frame: 6 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 NCT03060135, 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 25 Oct 2017.