CClinicalTrials.gg
CompletedNCT03601793Updated Jun 25, 2019

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

An interventional study of Alcohol Help Center and Assistance from a health educator in Alcohol Problem, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-06-25.

Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Alcohol Problem
03

In context

Alcohol-Related Disorders

143 studies on the registry are indexed under Alcohol-Related Disorders; 22 are open to participants now.

This study's enrollment of 236 is above the median of 113 across 120 interventional studies indexed under Alcohol-Related Disorders.

Browse Alcohol-Related Disorders studies →

Lead sponsor

Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Being under 18 years of age
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
236 participants (actual)

Study arms

  • 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 · Behavioral: Assistance from a health educator

  • 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

Interventions

  • BehavioralAlcohol Help Center

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

  • BehavioralAssistance 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

06

What researchers measure

Primary outcomes

  1. Drinks preceding week

    Change in the number of standard drinks consumed during preceding week from baseline

    Time frame: 3 and 6 months

  2. Heavy drinking days preceding week

    Change in the number of heavy drinking days during preceding week from baseline

    Time frame: 3 and 6 months

Secondary outcomes

  1. Alcohol Use Disorders Identification Test (AUDIT)

    Assessment of alcohol problems

    Time frame: Baseline, 3 month follow up, 6 month follow up

  2. Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)

    Assessment of alcohol consumption (the first 3 items in AUDIT)

    Time frame: Baseline, 3 month follow up, 6 month follow up

  3. 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).

    Time frame: Baseline, 3 month follow up, 6 month follow up

  4. DSM criteria

    The 11 DSM criteria of alcohol use disorders (yes/no)

    Time frame: Baseline

  5. Previously received treatment or help for alcohol concerns

    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)

07

Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M5S 2S1, Canada
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03601793
Lead sponsor
Centre for Addiction and Mental Health
Responsible party
John Cunningham (Senior Scientist, Centre for Addiction and Mental Health) — Principal investigator
First posted
Jul 26, 2018
Start date
Aug 1, 2018
Primary completion
Jun 19, 2019
Completion
Jun 19, 2019
Last update
Jun 25, 2019

Study contacts

John A Cunningham, Ph.D.
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion