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

Alcohol Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601793
• Other study ID #: 029/2018
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: June 19, 2019

Study information

• Verified date: June 2019
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Problem

Intervention

Behavioral:
• Alcohol Help Center
An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems
• 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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drinks preceding week	Change in the number of standard drinks consumed during preceding week from baseline	3 and 6 months
Primary	Heavy drinking days preceding week	Change in the number of heavy drinking days during preceding week from baseline	3 and 6 months
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	Assessment of alcohol problems	Baseline, 3 month follow up, 6 month follow up
Secondary	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
Secondary	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
Secondary	DSM criteria	The 11 DSM criteria of alcohol use disorders (yes/no)	Baseline
Secondary	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)

External 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