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

NCT ID: NCT03421080

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

988 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2021-02-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Problem Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

MoodGYM

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

MoodGYM

Intervention Type BEHAVIORAL

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 Drinking

Intervention Type BEHAVIORAL

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.

Interventions

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MoodGYM

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.

Intervention Type BEHAVIORAL

Check Your Drinking

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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John Cunningham

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John A Cunningham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 34786350 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33961291 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30030322 (View on PubMed)

Related Links

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http://www.camh.ca/en/research

Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

Other Identifiers

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064/2017

Identifier Type: -

Identifier Source: org_study_id

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