- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02977026
Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition
Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition: Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
A questionnaire that asks individuals what components of an online intervention they might find useful.
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Experimental: Check Your Drinking (CYD)
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
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Experimental: Alcohol Help Centre (AHC)
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in number of drinks in a typical week from baseline
Time Frame: 6 months
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Sum of number of drinks consumed in a typical week
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: John A Cunningham, PhD, Centre for Addiction and Mental Health
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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