| Literature DB >> 30030322 |
John A Cunningham1,2,3, Christian S Hendershot1,2, Frances Kay-Lambkin4, Clayton Neighbors5, Kathleen M Griffiths3, Kylie Bennett6, Anthony Bennett6, Alexandra Godinho1,7, Christina Schell1.
Abstract
INTRODUCTION: Hazardous alcohol consumption is common among people experiencing depression, often acting to exacerbate depressive symptoms. While many people with these co-occurring disorders do not seek face-to-face treatment, they do seek help online. 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. In order to realise the potential of internet interventions, we need to develop an evidence base supporting the efficacy of internet interventions for co-occurring depression and hazardous alcohol use without any therapist involvement. This study aims to evaluate the effects on drinking, and on depressive symptoms, of combining an internet intervention targeting hazardous alcohol consumption with one for depression. METHODS AND ANALYSIS: A double blinded, parallel group randomised 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 randomised either to receive an established online intervention for depression (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 symptoms. It is predicted that participants receiving the CYD intervention in addition to MoodGYM will report greater postintervention reductions in alcohol consumption and depressive symptoms compared with those who received MoodGYM only. Hypothesised mediation and moderation effects will also be investigated. Using an intention-to-treat basis for the analyses, the hypotheses will be tested using a generalised linear hypothesis framework, and longitudinal analyses will use either generalised linear mixed modelling or generalised estimating equation approach where appropriate. ETHICS AND DISSEMINATION: This research comprises the crucial first steps in developing lower-cost and efficacious internet interventions for people suffering from depression who also drink in a hazardous fashion-promoting the widespread availability of care for those in need. This study has been approved by the standing ethics review committee of the Centre for Addiction and Mental Health, and findings will be disseminated in the form of at least one peer-reviewed article and presentations at conferences. TRIAL REGISTRATION NUMBER: NCT03421080; Pre-results. © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Entities:
Keywords: brief intervention; clinical trial; comorbidity; depression; hazardous alcohol use; internet intervention; problem drinking; randomized controlled trial; trial protocol
Mesh:
Year: 2018 PMID: 30030322 PMCID: PMC6059322 DOI: 10.1136/bmjopen-2018-022412
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Figure 1Overview of the proposed intervention trial.
Study assessment points and instruments
| Study period | ||||
| Enrolment | Allocation | Postallocation | Close-out | |
| Time point | −t1 | 0 | t3m | t6m |
| Enrolment | ||||
| Eligibility screen | X | |||
| Informed consent | X | |||
| Allocation | X | |||
| Interventions | ||||
| MoodGYM only | X | |||
| MoodGYM+CYD | X | |||
| Assessments | ||||
| Baseline variables | ||||
| Demographics | X | |||
| Drinking Motives Questionnaire subscale | X | |||
| Alcohol-related treatment access | X | X | X | |
| PHQ-9 | X | X | X | |
| GAD-7 | X | X | X | |
| Toronto Alexithymia scale | X | |||
| Treatment for depression access | X | X | X | |
| Primary outcomes | ||||
| No of drinks in a typical week | X | X | X | |
| Secondary outcomes | ||||
| CES-D | X | X | X | |
| AUDIT-C | X | X | X | |
| Alcohol consequences | X | X | X | |
| Other variables | ||||
| EUROHIS-QoL-8 | X | X | X | |
| Use of interventions | X | X | ||
AUDIT, Alcohol Use Disorder Identification Test; CES-D, Centre for Epidemiological Studies—Depression; CYD, Check Your Drinking; EUROHIS-QoL-8, European Health Interview Survey—Quality of Life 8-item; GAD-7, Generalized Anxiety Disorder 7-item; PHQ-9, Patient Health Questionnaire.