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Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption

Primary Purpose

Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Check Your Drinking
Hello Sunday Morning
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Consumption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or over
  • A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
  • Typically consumes 15 or more drinks per week,
  • Willingness to complete a 6-month follow-up survey

Exclusion Criteria: None

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

No Intervention: Control

Check Your Drinking (CYD)

Hello Sunday Morning

Arm Description

A questionnaire that asks individuals what components of an online intervention they might find useful.

The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking

Internet based program designed to assess drinking patterns, and support self-determined goals for abstinence, by providing users with an online platform and community to discuss progress and goals.

Outcomes

Primary Outcome Measures

Change in the variable, number of drinks in a typical week, from baseline measurement to 6-month follow-up
Sum of number of drinks consumed in a typical week

Secondary Outcome Measures

Full Information

First Posted
February 17, 2017
Last Updated
October 24, 2017
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03060135
Brief Title
Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption
Official Title
Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
October 23, 2017 (Actual)
Study Completion Date
October 23, 2017 (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
There are a number of popular, freely available online interventions targeting hazardous alcohol consumption. Unfortunately, most have limited or no published evidence regarding their efficacy. Of particular interest is the intervention, 'Hello Sunday Morning.' The current project proposes to evaluate its' efficacy employing a RCT, using The Check Your Drinking intervention as an active comparator in the trial. Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who agree to be followed-up will be assigned by chance to be asked versus not asked to access one of the interventions and then recontacted 6 months later to ask about their drinking and their impressions of the online intervention. The primary hypothesis to be tested is that participants receiving access to any of the online interventions will report a greater level of reduction in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the control condition.

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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
878 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention: Control
Arm Type
No Intervention
Arm Description
A questionnaire that asks individuals what components of an online intervention they might find useful.
Arm Title
Check Your Drinking (CYD)
Arm Type
Active Comparator
Arm Description
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
Arm Title
Hello Sunday Morning
Arm Type
Experimental
Arm Description
Internet based program designed to assess drinking patterns, and support self-determined goals for abstinence, by providing users with an online platform and community to discuss progress and goals.
Intervention Type
Behavioral
Intervention Name(s)
Check Your Drinking
Intervention Description
A anonymous brief survey designed to provide normative feedback of individual's drinking with the intent of motivating reductions in drinking
Intervention Type
Behavioral
Intervention Name(s)
Hello Sunday Morning
Intervention Description
Brief online intervention that allows Individual's reflect on their drinking reductions progress and goals.
Primary Outcome Measure Information:
Title
Change in the variable, number of drinks in a typical week, from baseline measurement to 6-month follow-up
Description
Sum of number of drinks consumed in a typical week
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or over A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT) Typically consumes 15 or more drinks per week, Willingness to complete a 6-month follow-up survey Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Cunningham, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32040383
Citation
Schell C, Godinho A, Cunningham JA. To thine own self, be true: Examining change in self-reported alcohol measures over time as related to socially desirable responding bias among people with unhealthy alcohol use. Subst Abus. 2021;42(1):87-93. doi: 10.1080/08897077.2019.1697998. Epub 2020 Feb 10.
Results Reference
derived
PubMed Identifier
31200648
Citation
Cunningham JA, Godinho A, Bertholet N. Outcomes of two randomized controlled trials, employing participants recruited through Mechanical Turk, of Internet interventions targeting unhealthy alcohol use. BMC Med Res Methodol. 2019 Jun 14;19(1):124. doi: 10.1186/s12874-019-0770-4.
Results Reference
derived
Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

Learn more about this trial

Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption

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