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

Using Assistance From a Health Educator to Increase Effectiveness of an Internet Intervention for Alcohol Problems. A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Problem
• Intervention / Treatment: Behavioral: Alcohol Help Center; Behavioral: Assistance from a health educator

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

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).

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 2S1
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Alcohol Help Center; An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems; 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
Active Comparator: Internet intervention without assistance; This arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator.	Behavioral: Alcohol Help Center; An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinks preceding week	Change in the number of standard drinks consumed during preceding week from baseline	3 and 6 months
Heavy drinking days preceding week	Change in the number of heavy drinking days during preceding week from baseline	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Disorders Identification Test (AUDIT)	Assessment of alcohol problems	Baseline, 3 month follow up, 6 month follow up
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)	Assessment of alcohol consumption (the first 3 items in AUDIT)	Baseline, 3 month follow up, 6 month follow up
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).	Baseline, 3 month follow up, 6 month follow up
DSM criteria	The 11 DSM criteria of alcohol use disorders (yes/no)	Baseline
Previously received treatment or help for alcohol concerns	Questions about what kind of treatment or help for alcohol concerns the participant has received previously	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)

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): June 19, 2019
• Study Completion (Actual): June 19, 2019

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Alcohol-Related Disorders
• Other Study ID Numbers: 029/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No