- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03421080
Brief Internet Intervention for Hazardous Alcohol Use to People Seeking Online Help for Depression
February 3, 2021 updated by: John Cunningham, Centre for Addiction and Mental Health
Does Providing a Brief Internet Intervention for Hazardous Alcohol Use to People Seeking Online Help for Depression Reduce Both Alcohol Use and Depression Symptoms Among Participants With These Co-occurring Disorders? Randomized Controlled Trial
Hazardous alcohol consumption is common among people suffering from depression.
There are effective Internet interventions that target hazardous alcohol consumption or depression separately but none that combine these online interventions without the involvement of a therapist.
This study aims to evaluate the effects of combining an Internet intervention targeting hazardous alcohol consumption with one for depression on drinking and depressive symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A double-blinded, parallel group randomized controlled trial will be used.
Participants with current depression who also drink in a hazardous fashion (N=986) will be recruited for a study to 'help improve an online intervention for depression.' Participants will be assigned, by chance, to receive MoodGYM or to receive MoodGYM plus a brief Internet intervention for hazardous alcohol consumption - Check Your Drinking (CYD).
Participants will be contacted 3- and 6-months after receiving the interventions to assess changes in drinking and depression status.
It is predicted that participants receiving the CYD intervention in addition to MoodGYM will reduce their alcohol consumption to a greater extent than those who just received MoodGYM.
Further predictions include the impact of receiving Check Your Drinking on improvements in depressive symptoms.
Study Type
Interventional
Enrollment (Actual)
988
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S2S1
- Centre for Addiction and Mental Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or over
- score 10 or more on the Patient Health Questionnaire (PHQ-9)
- score 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)
Exclusion Criteria:
- current suicidal ideation on the PHQ-9
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: MoodGYM Only
The MoodGYM only Internet intervention will consist of a popular, automated, self-help cognitive behavioral therapy program for depression comprising five modules to be completed over five weeks and an online workbook incorporating 29 exercises.
A series of published research trials has shown MoodGYM to be effective in reducing depressive symptoms in users in a range of settings (e.g., schools, universities, Lifeline suicide prevention, U.K. NHS Choices online), for different aspects of the mental health service spectrum (e.g., prevention vs treatment), and different age groups (adults, adolescents).
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The MoodGYM Internet intervention will employ the latest version of MoodGYM (Mark 4) which has been updated to support mobile devices.
The core design and function of the program has not been altered.
A major focus of this intervention is to provide individuals with behavioral and cognitive strategies to improve depression symptoms.
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EXPERIMENTAL: MoodGYM + CYD
The MoodGYM + CYD intervention condition will consist of the MoodGYM only intervention and an online intervention providing feedback on quantity and frequency of drinking, severity of hazardous drinking, and provides recommendations for safe levels of alcohol consumption (Check Your Drinking - CYD).
The CYD Final Report will be provided as part of the participant's MoodDYM dashboard.
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The MoodGYM Internet intervention will employ the latest version of MoodGYM (Mark 4) which has been updated to support mobile devices.
The core design and function of the program has not been altered.
A major focus of this intervention is to provide individuals with behavioral and cognitive strategies to improve depression symptoms.
Internet intervention designed to assess and provide feedback on hazardous alcohol use.
The CYD has been subjected to seven randomized trials from two independent research groups, all of which displayed a significant impact of the CYD to reduce hazardous alcohol consumption compared to controls.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of drinks in a typical week
Time Frame: 3 and 6 months
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Change in number of drinks in a typical week from baseline
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3 and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CES-D
Time Frame: 3 and 6 months
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Change in depressive symptoms using the Centre for Epidemiological Studies Depression scale (CES-D) from baseline.
Total score range from zero to 60 with higher scores indicating more symptomatology.
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3 and 6 months
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AUDIT-C
Time Frame: 3 and 6 months
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Change in AUDIT-C score (consumption subscale from the AUDIT) from baseline
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3 and 6 months
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Alcohol consequences
Time Frame: 3 and 6 months
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Change in number of alcohol consequences from baseline
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3 and 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: 3 and 6 months
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Measure changes in health related quality of life from baseline (EUROHIS-QoL8)
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3 and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cunningham JA, Godinho A, Hendershot CS, Kay-Lambkin F, Neighbors C, Griffiths KM, Schell C. Randomized controlled trial of online interventions for co-occurring depression and hazardous alcohol consumption: Primary outcome results. Internet Interv. 2021 Nov 2;26:100477. doi: 10.1016/j.invent.2021.100477. eCollection 2021 Dec.
- Godinho A, Schell C, Cunningham JA. Falling between the cracks: The effect of using different levels of suicide risk exclusion criteria on sample characteristics when recruiting for an online intervention for depression. Suicide Life Threat Behav. 2021 Aug;51(4):736-740. doi: 10.1111/sltb.12761. Epub 2021 May 7.
- Cunningham JA, Hendershot CS, Kay-Lambkin F, Neighbors C, Griffiths KM, Bennett K, Bennett A, Godinho A, Schell C. Does providing a brief internet intervention for hazardous alcohol use to people seeking online help for depression reduce both alcohol use and depression symptoms among participants with these co-occurring disorders? Study protocol for a randomised controlled trial. BMJ Open. 2018 Jul 19;8(7):e022412. doi: 10.1136/bmjopen-2018-022412.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 26, 2018
Primary Completion (ACTUAL)
February 3, 2021
Study Completion (ACTUAL)
February 3, 2021
Study Registration Dates
First Submitted
January 29, 2018
First Submitted That Met QC Criteria
January 29, 2018
First Posted (ACTUAL)
February 5, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 3, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 064/2017
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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