Clinical trial NCT04745325: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 761
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: Total number of drinks consumed in a typical week
timeFrame: 6-months follow-up
Secondary outcomes:
measure: Frequency of heavy drinking days
timeFrame: 6-months follow-up
measure: Number of consequences associated with drinking
timeFrame: 6-months follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
Study officials:
References: