An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator
Primary Purpose
Alcohol Problem
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Alcohol Help Center
Assistance from a health educator
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Problem
Eligibility Criteria
Inclusion Criteria:
- A score of 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)
- A preceding week alcohol consumption of 14 standard drinks or more
Exclusion Criteria:
- Being under 18 years of age
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internet intervention with assistance
Internet intervention without assistance
Arm Description
This arm is given access to the internet intervention Alcohol Help Center with email assistance from a health educator during the first two weeks after randomization.
This arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator.
Outcomes
Primary Outcome Measures
Drinks preceding week
Change in the number of standard drinks consumed during preceding week from baseline
Heavy drinking days preceding week
Change in the number of heavy drinking days during preceding week from baseline
Secondary Outcome Measures
Alcohol Use Disorders Identification Test (AUDIT)
Assessment of alcohol problems
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
Assessment of alcohol consumption (the first 3 items in AUDIT)
EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)
Instrument measuring five health-related quality of life dimensions. Each dimension has five levels ranging from no problems to extreme problems. The dimensions can be combined into an index value between 0 (lowest) and 1 (highest). In addition to the five dimensions, a visual analogue scale item allows participants to measure health outcomes that reflect the participant's judgement. Endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0).
DSM criteria
The 11 DSM criteria of alcohol use disorders (yes/no)
Previously received treatment or help for alcohol concerns
Questions about what kind of treatment or help for alcohol concerns the participant has received previously
Full Information
NCT ID
NCT03601793
First Posted
July 16, 2018
Last Updated
June 24, 2019
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT03601793
Brief Title
An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator
Official Title
Using Assistance From a Health Educator to Increase Effectiveness of an Internet Intervention for Alcohol Problems. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
June 19, 2019 (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
The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.
Detailed Description
This project aims to study the previously evaluated multi-module internet intervention Alcohol Help Center delivered with assistance from a health educator (AHC+A). The assistance will be in the form of email contact with the participant during the first two weeks after randomization. AHC+A will be tested against a group receiving access to the intervention without any such assistance (AHC).
The Investigators hypothesize that
participants allocated to AHC+A will display significant reductions in drinking (drinks preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared to AHC
participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC
engagement with the intervention will mediate any effects on drinking behavior.
A 2-arm parallel group randomized controlled trial will be used to test these specified hypotheses. Follow-ups will be conducted at 3 and 6 months after randomization. Online media advertisements will be used to recruit people with current alcohol problems, and will target people who are 'experiencing difficulties in controlling or cutting down on their drinking.' The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Problem
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet intervention with assistance
Arm Type
Experimental
Arm Description
This arm is given access to the internet intervention Alcohol Help Center with email assistance from a health educator during the first two weeks after randomization.
Arm Title
Internet intervention without assistance
Arm Type
Active Comparator
Arm Description
This arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Help Center
Intervention Description
An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems
Intervention Type
Behavioral
Intervention Name(s)
Assistance from a health educator
Intervention Description
This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks
Primary Outcome Measure Information:
Title
Drinks preceding week
Description
Change in the number of standard drinks consumed during preceding week from baseline
Time Frame
3 and 6 months
Title
Heavy drinking days preceding week
Description
Change in the number of heavy drinking days during preceding week from baseline
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
Assessment of alcohol problems
Time Frame
Baseline, 3 month follow up, 6 month follow up
Title
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
Description
Assessment of alcohol consumption (the first 3 items in AUDIT)
Time Frame
Baseline, 3 month follow up, 6 month follow up
Title
EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)
Description
Instrument measuring five health-related quality of life dimensions. Each dimension has five levels ranging from no problems to extreme problems. The dimensions can be combined into an index value between 0 (lowest) and 1 (highest). In addition to the five dimensions, a visual analogue scale item allows participants to measure health outcomes that reflect the participant's judgement. Endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0).
Time Frame
Baseline, 3 month follow up, 6 month follow up
Title
DSM criteria
Description
The 11 DSM criteria of alcohol use disorders (yes/no)
Time Frame
Baseline
Title
Previously received treatment or help for alcohol concerns
Description
Questions about what kind of treatment or help for alcohol concerns the participant has received previously
Time Frame
Baseline (treatment or help ever/in the past 12 months), 3 month follow up (treatment or help in the past 3 months), 6 month follow up (treatment or help in the past 3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A score of 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)
A preceding week alcohol consumption of 14 standard drinks or more
Exclusion Criteria:
Being under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Cunningham, Ph.D.
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
Links:
URL
http://www.camh.ca/en/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
An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator
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