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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
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Problem

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 16, 2018
Last Updated
June 24, 2019
Sponsor
Centre for Addiction and Mental Health
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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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