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

Alcohol Consumption Clinical Trial

Official title:

Assessing the Effectiveness and Mechanisms of Action of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745325
• Other study ID #: 052/2020
• Status: Completed
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: July 2023
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: April 30, 2023
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• score of 8 or more on the Alcohol Use Disorders Identification Test

• currently us a smartphone running iOS or Android

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of drinks consumed in a typical week	self-reported change	6-months follow-up
Secondary	Frequency of heavy drinking days	self-reported change	6-months follow-up
Secondary	Number of consequences associated with drinking	self-reported change	6-months follow-up