NCT03601793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

July 16, 2018

Last Update Submit

June 24, 2019

Conditions

Alcohol Problem

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Alcohol Use Disorders Identification Test (AUDIT)

    Baseline, 3 month follow up, 6 month follow up

  • Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)

    Baseline, 3 month follow up, 6 month follow up

  • EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)

    Baseline, 3 month follow up, 6 month follow up

  • DSM criteria

    Baseline

  • Previously received treatment or help for alcohol concerns

    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)

Study Arms (2)

Internet intervention with assistance

EXPERIMENTAL

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 CenterBehavioral: Assistance from a health educator

Internet intervention without assistance

ACTIVE COMPARATOR

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

Behavioral: Alcohol Help Center

Interventions

Alcohol Help CenterBEHAVIORAL

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

Internet intervention with assistanceInternet intervention without assistance
Assistance from a health educatorBEHAVIORAL

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

Internet intervention with assistance

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Being under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

MeSH Terms

Conditions

Alcohol-Related Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • John A Cunningham, Ph.D.

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

July 16, 2018

First Posted

July 26, 2018

Study Start

August 1, 2018

Primary Completion

June 19, 2019

Study Completion

June 19, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)