NCT03060135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
878

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 24, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

February 17, 2017

Last Update Submit

October 24, 2017

Conditions

Alcohol Consumption

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (3)

No Intervention: Control

NO INTERVENTION

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

Check Your Drinking (CYD)

ACTIVE COMPARATOR

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

Behavioral: Check Your Drinking

Hello Sunday Morning

EXPERIMENTAL

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.

Behavioral: Hello Sunday Morning

Interventions

Check Your DrinkingBEHAVIORAL

A anonymous brief survey designed to provide normative feedback of individual's drinking with the intent of motivating reductions in drinking

Check Your Drinking (CYD)
Hello Sunday MorningBEHAVIORAL

Brief online intervention that allows Individual's reflect on their drinking reductions progress and goals.

Hello Sunday Morning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 32040383DERIVED

  • 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.

    PMID: 31200648DERIVED

Related Links

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • John A Cunningham, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 23, 2017

Study Start

February 24, 2017

Primary Completion

October 23, 2017

Study Completion

October 23, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)