NCT02977026

Brief Summary

Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings. One promising strategy is Internet-based interventions for problem drinkers. Our recently completed RCT comparing a brief (Check Your Drinking; CYD) versus an extended (Alcohol Help Centre; AHC) Internet intervention for problem drinkers found that, while there was a reduction in drinking across time for both interventions, there was no significant (p \> .05) difference in reductions in drinking between the two interventions. Based on these results, it is not justifiable to say that either intervention 'worked' as there was no comparison condition of participants who received no active intervention. The current trial proposes to address this limitation by conducting an RCT comparing the CYD, AHC, and a no intervention control condition. Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who are interested will be randomized to receive access to the Check Your Drinking screener (CYD condition), Alcohol Help Centre (AHC condition) or a feedback questionnaire (control condition). At six-months post-baseline, the MTurk portal will be used to send invitation emails that contain a link to the follow-up survey. The primary hypothesis to be tested is that participants receiving access to the AHC intervention will report a greater reduction in AUDIT-C scores and in number of drinks in a typical week than participants in the CYD intervention. Further, participants in the CYD condition will report a greater level of reduction AUDIT-C scores and in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the no intervention control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
511

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

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

November 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

November 27, 2016

Last Update Submit

August 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in number of drinks in a typical week from baseline

    Sum of number of drinks consumed in a typical week

    6 months

Study Arms (3)

Control

NO INTERVENTION

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

Check Your Drinking (CYD)

EXPERIMENTAL

Internet based program of lower intensity as compared to the "Alcohol Help Centre. It was designed to provide personalized normative feedback aimed at motivating reductions in drinking

Behavioral: CYD

Alcohol Help Centre (AHC)

EXPERIMENTAL

Internet based program of higher intensity as compared to the "Check Your Drinking" intervention. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding drinking.

Behavioral: AHC

Interventions

CYDBEHAVIORAL
Check Your Drinking (CYD)
AHCBEHAVIORAL
Alcohol Help Centre (AHC)

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)

  • Godinho A, Schell C, Cunningham JA. How one small text change in a study document can impact recruitment rates and follow-up completions. Internet Interv. 2019 Oct 20;18:100284. doi: 10.1016/j.invent.2019.100284. eCollection 2019 Dec.

  • 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.

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

November 27, 2016

First Posted

November 30, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations