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

Study Overview
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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.

Official Title
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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

Conditions
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Depression, Problem Drinking

Intervention / Treatment
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* Behavioral: MoodGYM
* Behavioral: Check Your Drinking


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MoodGYM Only<br>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<br>* 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.<br>|
| Experimental: MoodGYM + CYD<br>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<br>* 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.<br>Behavioral: Check Your Drinking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of drinks in a typical week | Change in number of drinks in a typical week from baseline | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| AUDIT-C | Change in AUDIT-C score (consumption subscale from the AUDIT) from baseline | 3 and 6 months | 
| Alcohol consequences | Change in number of alcohol consequences from baseline | 3 and 6 months |