Randomized Trial of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04745325
Collaborator
(none)
754
1
2
21.1
35.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SMAART Canada smartphone app
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
754 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Assessing the Effectiveness and Mechanisms of Action of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption: Randomized Controlled Trial
Actual Study Start Date :
May 27, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Smartphone app - full access

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").

Behavioral: SMAART Canada smartphone app
a smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazardous fashion

Active Comparator: Smartphone App - education only

A version of the Smartphone app containing only the module with the educational information on alcohol use and its consequences (i.e. "fact sheets").

Behavioral: SMAART Canada smartphone app
a smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazardous fashion

Outcome Measures

Primary Outcome Measures

  1. Total number of drinks consumed in a typical week [6-months follow-up]

    self-reported change

Secondary Outcome Measures

  1. Frequency of heavy drinking days [6-months follow-up]

    self-reported change

  2. Number of consequences associated with drinking [6-months follow-up]

    self-reported change

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • score of 8 or more on the Alcohol Use Disorders Identification Test

  • currently us a smartphone running iOS or Android

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Addiction and Mental Health Toronto Canada

Sponsors and Collaborators

  • Centre for Addiction and Mental Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Cunningham, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT04745325
Other Study ID Numbers:
  • 052/2020
First Posted:
Feb 9, 2021
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022