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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421080
• Other study ID #: 064/2017
• Status: Completed
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: February 3, 2021

Study information

• Verified date: February 2021
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 988
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Depression
• Depressive Disorder
• Problem Drinking

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health related quality of life	Measure changes in health related quality of life from baseline (EUROHIS-QoL8)	3 and 6 months
Primary	Number of drinks in a typical week	Change in number of drinks in a typical week from baseline	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	AUDIT-C	Change in AUDIT-C score (consumption subscale from the AUDIT) from baseline	3 and 6 months
Secondary	Alcohol consequences	Change in number of alcohol consequences from baseline	3 and 6 months

External Links

•   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