Clinical trial NCT03601793: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Problem
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

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

Primary outcomes:
measure: Drinks preceding week
timeFrame: 3 and 6 months
measure: Heavy drinking days preceding week
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline, 3 month follow up, 6 month follow up
measure: Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
timeFrame: Baseline, 3 month follow up, 6 month follow up
measure: EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)
timeFrame: Baseline, 3 month follow up, 6 month follow up
measure: DSM criteria
timeFrame: Baseline
measure: Previously received treatment or help for alcohol concerns
timeFrame: 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)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John A Cunningham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: