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DepressionNCT03421080

Brief Internet Intervention for Hazardous Alcohol Use to People Seeking Online Help for Depression

A study testing MoodGYM and Check Your Drinking in people with Depression and Problem Drinking, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Problem Drinking
What is being tested?
MoodGYM and Check Your Drinking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
988 participants
Where
1 siteCanada
Study dates
26 Apr 2018to 3 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • current suicidal ideation on the PHQ-9

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5S2S1

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
MoodGYM, Check Your Drinking
Medical subject headings
Depression, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoodGYMBehavioural

    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.

  • Check Your DrinkingBehavioural

    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.

Study groups in NCT03421080
Study groupRoleWhat they receive
MoodGYM OnlyActive comparatorThe 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).
Receives: Behavioral: MoodGYM
MoodGYM + CYDExperimentalThe 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.
Receives: Behavioral: MoodGYM; Behavioral: Check Your Drinking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of drinks in a typical week

    Change in number of drinks in a typical week from baseline

    Measured: 3 and 6 months

Secondary outcomes (3)

  1. CES-D

    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.

    Measured: 3 and 6 months

  2. AUDIT-C

    Change in AUDIT-C score (consumption subscale from the AUDIT) from baseline

    Measured: 3 and 6 months

  3. Alcohol consequences

    Change in number of alcohol consequences from baseline

    Measured: 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start26 Apr 2018
  3. Primary completion3 Feb 2021
  4. Study completion3 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
988 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03421080
Sponsor's protocol ID
064/2017
Status last verified
Feb 2021
First submitted
29 Jan 2018
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34786350

  • 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.

    PubMed 33961291

  • 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.

    PubMed 30030322

Questions about this trial

What is this clinical trial studying?

A study testing MoodGYM and Check Your Drinking in people with Depression and Problem Drinking, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of drinks in a typical week (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03421080, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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