Randomized Trial of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption
Primary Purpose
Alcohol Consumption
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SMAART Canada smartphone app
Sponsored by

About this trial
This is an interventional treatment trial for Alcohol Consumption
Eligibility Criteria
Inclusion Criteria:
- score of 8 or more on the Alcohol Use Disorders Identification Test
- currently us a smartphone running iOS or Android
Exclusion Criteria:
-
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smartphone app - full access
Smartphone App - education only
Arm Description
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").
A version of the Smartphone app containing only the module with the educational information on alcohol use and its consequences (i.e. "fact sheets").
Outcomes
Primary Outcome Measures
Total number of drinks consumed in a typical week
self-reported change
Secondary Outcome Measures
Frequency of heavy drinking days
self-reported change
Number of consequences associated with drinking
self-reported change
Full Information
NCT ID
NCT04745325
First Posted
February 4, 2021
Last Updated
July 5, 2023
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT04745325
Brief Title
Randomized Trial of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption
Official Title
Assessing the Effectiveness and Mechanisms of Action of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
761 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smartphone app - full access
Arm Type
Experimental
Arm Description
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").
Arm Title
Smartphone App - education only
Arm Type
Active Comparator
Arm Description
A version of the Smartphone app containing only the module with the educational information on alcohol use and its consequences (i.e. "fact sheets").
Intervention Type
Behavioral
Intervention Name(s)
SMAART Canada smartphone app
Intervention Description
a smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazardous fashion
Primary Outcome Measure Information:
Title
Total number of drinks consumed in a typical week
Description
self-reported change
Time Frame
6-months follow-up
Secondary Outcome Measure Information:
Title
Frequency of heavy drinking days
Description
self-reported change
Time Frame
6-months follow-up
Title
Number of consequences associated with drinking
Description
self-reported change
Time Frame
6-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
score of 8 or more on the Alcohol Use Disorders Identification Test
currently us a smartphone running iOS or Android
Exclusion Criteria:
-
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption
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