An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator

NCT ID: NCT03601793

Last Updated: 2019-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-06-19

Brief Summary

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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

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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

1. 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
2. participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC
3. 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).

Conditions

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Alcohol Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Internet intervention with assistance

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.

Group Type EXPERIMENTAL

Alcohol Help Center

Intervention Type BEHAVIORAL

An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems

Assistance from a health educator

Intervention Type BEHAVIORAL

This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks

Internet intervention without assistance

This arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator.

Group Type ACTIVE_COMPARATOR

Alcohol Help Center

Intervention Type BEHAVIORAL

An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems

Interventions

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Alcohol Help Center

An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems

Intervention Type BEHAVIORAL

Assistance from a health educator

This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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John Cunningham

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John A Cunningham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://www.camh.ca/en/research

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

Other Identifiers

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029/2018

Identifier Type: -

Identifier Source: org_study_id

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