Alcohol ConsumptionNCT04745325
Randomized Trial of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption
A study testing SMAART Canada smartphone app in people with Alcohol Consumption, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Smartphone apps targeting alcohol consumption are increasingly employed as a means to help people reduce their alcohol consumption. Recognizing this potential, there has been an explosion of app development for unhealthy alcohol use, as well as other health-related behaviours. 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?
- SMAART Canada smartphone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 761 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2021to 30 Apr 2023
- 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
- score of 8 or more on the Alcohol Use Disorders Identification Test
- currently us a smartphone running iOS or Android
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effectiveness and Mechanisms of Action of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption: Randomized Controlled Trial
Smartphone apps targeting alcohol consumption are increasingly employed as a means to help people reduce their alcohol consumption. Recognizing this potential, there has been an explosion of app development for unhealthy alcohol use, as well as other health-related behaviours. This study will recruit people who consume alcohol in an unhealthy manner. Participants will be assigned by chance to one of two groups and will be contacted 6 months after consenting to the study to assess changes in their drinking. In addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption. An app with proven efficacy, made widely available and free-of-charge to Canadians, will provide a much needed option to help those in need to reduce their alcohol use.
Read the detailed description
Unhealthy alcohol use is common and causes tremendous harm. Most people with unhealthy alcohol use will never seek formal alcohol treatment. As an alternative, smartphone apps have been developed as one means to provide help to people concerned about their alcohol use. While such apps are widely available, the large majority have little or no evidence base, and research has indicated that some may actually do more harm than good. An app with proven efficacy at reducing alcohol consumption is needed in order to capitalize on this opportunity to motivate the large number of people seeking assistance using this promising technology.
This study will recruit people who consume alcohol in an unhealthy manner. Participants will be assigned by chance to one of two groups to either receive access to: 1) the full app; or 2) a copy of the app where only the educational content is provided (as opposed to the full intervention content of the app). Participants will be contacted 6 months after consenting to the study to assess changes in their drinking. We predict that the full app will lead to larger reductions in drinking and a more sustained impact than the educational content only app. In addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption.
- Conditions
- Alcohol Consumption
- Being tested
- SMAART Canada smartphone app
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMAART Canada smartphone appBehavioural
a smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazardous fashion
| Study group | Role | What they receive |
|---|---|---|
| Smartphone app - full access | Experimental | A smartphone app containing 5 modules: 1) personalized feedback on alcohol use (containing normative feedback by age and sex for those located in the Canada), 2) self-monitoring and goal setting tool, 3) tool to choose a designated driver, 4) blood alcohol content (BAC) calculator, and 5) educational information on alcohol use and its consequences (i.e. "fact sheets"). Receives: Behavioral: SMAART Canada smartphone app |
| Smartphone App - education only | Active comparator | A version of the Smartphone app containing only the module with the educational information on alcohol use and its consequences (i.e. "fact sheets"). Receives: Behavioral: SMAART Canada smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of drinks consumed in a typical week
self-reported change
Measured: 6-months follow-up
Secondary outcomes (2)
Frequency of heavy drinking days
self-reported change
Measured: 6-months follow-up
Number of consequences associated with drinking
self-reported change
Measured: 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start27 May 2021
- Primary completion26 Oct 2022
- Study completion30 Apr 2023
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 761 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745325
- Sponsor's protocol ID
- 052/2020
- Status last verified
- Jul 2023
- First submitted
- 4 Feb 2021
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cunningham JA, Godinho A, Schell C, Studer J, Wardell JD, Garnett C, Bertholet N. Randomized controlled trial of a smartphone app designed to reduce unhealthy alcohol consumption. Internet Interv. 2024 May 17;36:100747. doi: 10.1016/j.invent.2024.100747. eCollection 2024 Jun.
PubMed 38812955
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness and Mechanisms of Action of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04745325
- Acronym / sponsor ID
- 052/2020
- Conditions
- Alcohol Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 9 Feb 2021 (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.
Smartphone apps targeting alcohol consumption are increasingly employed as a means to help people reduce their alcohol consumption. Recognizing this potential, there has been an explosion of app development for unhealthy alcohol use, as well as other health-related behaviours. This study will recruit people who consume alcohol in an unhealthy manner. Participants will be assigned by chance to one of two groups and will be contacted 6 months after consenting to the study to assess changes in their drinking. In addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption. An app with proven efficacy, made widely available and free-of-charge to Canadians, will provide a much needed option to help those in need to reduce their alcohol use.
Detailed description
Unhealthy alcohol use is common and causes tremendous harm. Most people with unhealthy alcohol use will never seek formal alcohol treatment. As an alternative, smartphone apps have been developed as one means to provide help to people concerned about their alcohol use. While such apps are widely available, the large majority have little or no evidence base, and research has indicated that some may actually do more harm than good. An app with proven efficacy at reducing alcohol consumption is needed in order to capitalize on this opportunity to motivate the large number of people seeking assistance using this promising technology.
This study will recruit people who consume alcohol in an unhealthy manner. Participants will be assigned by chance to one of two groups to either receive access to: 1) the full app; or 2) a copy of the app where only the educational content is provided (as opposed to the full intervention content of the app). Participants will be contacted 6 months after consenting to the study to assess changes in their drinking. We predict that the full app will lead to larger reductions in drinking and a more sustained impact than the educational content only app. In addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone app - full access | Experimental | Behavioral: SMAART Canada smartphone appA smartphone app containing 5 modules: 1) personalized feedback on alcohol use (containing normative feedback by age and sex for those located in the Canada), 2) self-monitoring and goal setting tool, 3) tool to choose a designated driver, 4) blood alcohol content (BAC) calculator, and 5) educational information on alcohol use and its consequences (i.e. "fact sheets"). |
| Smartphone App - education only | Active comparator | Behavioral: SMAART Canada smartphone appA version of the Smartphone app containing only the module with the educational information on alcohol use and its consequences (i.e. "fact sheets"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- score of 8 or more on the Alcohol Use Disorders Identification Test
- currently us a smartphone running iOS or Android
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 |
|---|---|---|
| SMAART Canada smartphone appa smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazardous fashion | Behavioural | Smartphone App - education only, Smartphone app - full access |
Primary outcome
Total number of drinks consumed in a typical week
Time frame: 6-months follow-up
self-reported change
2 secondary outcomes
Frequency of heavy drinking days
Time frame: 6-months follow-up
Number of consequences associated with drinking
Time frame: 6-months follow-up
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 7 Jul 2023.
- Derived from this study: PubMed 38812955Cunningham JA, Godinho A, Schell C, Studer J, Wardell JD, Garnett C, Bertholet N. Randomized controlled trial of a smartphone app designed to reduce unhealthy alcohol consumption. Internet Interv. 2024 May 17;36:100747. doi: 10.1016/j.invent.2024.100747. eCollection 2024 Jun.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMAART Canada smartphone app 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 2 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 7 Jul 2023. 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?
Total number of drinks consumed in a typical week (time frame: 6-months follow-up). 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 NCT04745325, 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 7 Jul 2023.