Clinical trial NCT03421080: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Problem Drinking
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 988
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of drinks in a typical week
timeFrame: 3 and 6 months
Secondary outcomes:
measure: CES-D
timeFrame: 3 and 6 months
measure: AUDIT-C
timeFrame: 3 and 6 months
measure: Alcohol consequences
timeFrame: 3 and 6 months
Other outcomes:
measure: Health related quality of life
timeFrame: 3 and 6 months
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John A Cunningham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.