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

Primary Purpose

Depression, Problem Drinking

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MoodGYM
Check Your Drinking
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MoodGYM Only

MoodGYM + CYD

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Number of drinks in a typical week
Change in number of drinks in a typical week from baseline

Secondary Outcome Measures

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.
AUDIT-C
Change in AUDIT-C score (consumption subscale from the AUDIT) from baseline
Alcohol consequences
Change in number of alcohol consequences from baseline

Full Information

First Posted
January 29, 2018
Last Updated
February 3, 2021
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03421080
Brief Title
Brief Internet Intervention for Hazardous Alcohol Use to People Seeking Online Help for Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
February 3, 2021 (Actual)
Study Completion Date
February 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Problem Drinking

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
988 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MoodGYM Only
Arm Type
Active Comparator
Arm Description
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).
Arm Title
MoodGYM + CYD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MoodGYM
Intervention Description
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
Intervention Name(s)
Check Your Drinking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of drinks in a typical week
Description
Change in number of drinks in a typical week from baseline
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
CES-D
Description
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.
Time Frame
3 and 6 months
Title
AUDIT-C
Description
Change in AUDIT-C score (consumption subscale from the AUDIT) from baseline
Time Frame
3 and 6 months
Title
Alcohol consequences
Description
Change in number of alcohol consequences from baseline
Time Frame
3 and 6 months
Other Pre-specified Outcome Measures:
Title
Health related quality of life
Description
Measure changes in health related quality of life from baseline (EUROHIS-QoL8)
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Cunningham, Ph.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S2S1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34786350
Citation
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.
Results Reference
derived
PubMed Identifier
33961291
Citation
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.
Results Reference
derived
PubMed Identifier
30030322
Citation
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.
Results Reference
derived
Links:
URL
http://www.camh.ca/en/research
Description
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

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

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