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Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition

Primary Purpose

Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CYD
AHC
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

Experimental

Experimental

Arm Label

Control

Check Your Drinking (CYD)

Alcohol Help Centre (AHC)

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Change in number of drinks in a typical week from baseline
Sum of number of drinks consumed in a typical week

Secondary Outcome Measures

Full Information

First Posted
November 27, 2016
Last Updated
August 10, 2017
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02977026
Brief Title
Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition
Official Title
Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

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
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
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
Experimental
Arm Description
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
Arm Title
Alcohol Help Centre (AHC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CYD
Intervention Type
Behavioral
Intervention Name(s)
AHC
Primary Outcome Measure Information:
Title
Change in number of drinks in a typical week from baseline
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
31890631
Citation
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.
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

Learn more about this trial

Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition

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