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

NCT03421080 | Completed

• 1 other identifier: 064/2017
• Study Type: interventional
• Target: 988
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Problem Drinking

Outcome Measures

Primary Outcomes (1)

• Number of drinks in a typical week

  Change in number of drinks in a typical week from baseline

  3 and 6 months

Secondary Outcomes (3)

• CES-D

  3 and 6 months

• AUDIT-C

  3 and 6 months

• Alcohol consequences

  3 and 6 months

Other Outcomes (1)

• Health related quality of life

  3 and 6 months

Study Arms (2)

MoodGYM Only

ACTIVE COMPARATOR

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).

Behavioral: MoodGYM

MoodGYM + CYD

EXPERIMENTAL

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.

Behavioral: MoodGYM; Behavioral: Check Your Drinking

Interventions

MoodGYM 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; MoodGYM Only

Check Your Drinking 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.

MoodGYM + CYD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• current suicidal ideation on the PHQ-9

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S2S1, Canada

Location

Related Publications (3)

• 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.

  PMID: 34786350 DERIVED

• 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.

  PMID: 33961291 DERIVED

• 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.

  PMID: 30030322 DERIVED

Related 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

MeSH Terms

Conditions

Depression; Alcoholism

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• John A Cunningham, Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: April 26, 2018
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)