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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? Study protocol for a randomised controlled trial
  1. John A Cunningham1,2,3,
  2. Christian S Hendershot1,2,
  3. Frances Kay-Lambkin4,
  4. Clayton Neighbors5,
  5. Kathleen M Griffiths3,
  6. Kylie Bennett6,
  7. Anthony Bennett6,
  8. Alexandra Godinho1,7,
  9. Christina Schell1
  1. 1 Institute of Mental Health and Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  2. 2 Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
  3. 3 Research School of Public Health, Austalian National University, Canberra, Australian Capital Territory, Australia
  4. 4 School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia
  5. 5 Department of Psychology, University of Houston, Houston, Texas, USA
  6. 6 eHub Health Pty Ltd, Canberra, Australian Capital Territory, Australia
  7. 7 Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Professor John A Cunningham; john.cunningham{at}camh.ca

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.

  • clinical trial
  • randomized controlled trial
  • brief intervention
  • internet intervention
  • trial protocol
  • depression
  • hazardous alcohol use
  • problem drinking
  • comorbidity

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors All authors have made an intellectual contribution to this research trial. JAC is the principal investigator of the trial, with overall responsibility for the project. JAC, CSH, FK-L, CN and KMG conceived the design and wrote the grant application. JAC, CSH, AG, CN and CS developed the protocol and wrote the first draft of this manuscript. AB and KB developed the online tool and conceived of and developed the online RCT platform for conducting the current study. All authors have contributed to the manuscript drafting process and have read and approved the final manuscript.

  • Funding This research is funded by the Canadian Institutes of Health Research grant no PJT 153 324.

  • Competing interests KB and AB are owners and employees of eHub Health Pty Ltd which has a commercial license to deliver the interventions. KMG is entitled to a share of royalties generated by the commercialisation of MoodGYM. The authors declare that they have no other competing interest.

  • Patient consent Obtained.

  • Ethics approval This research was approved by the Ethics Review Board at the Centre for Addiction and Mental Health.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Study materials are available from the corresponding author.

  • Author note Since there are minimal risks related to receiving these online interventions, a Data Monitoring Committee will not be formed, and interim analyses will not be performed. It has been demonstrated in previous online trials evaluating internet interventions for depression that rates of symptom exacerbation and suicide risk are extremely low in this non-treatment seeking population. If participants express suicidal ideation at baseline (excluded from the trial) or at 3-month or 6-month follow-ups, they will see a pop-up window encouraging them to seek help and provide relevant contact information. In addition, contact information for trial staff will be provided at all points throughout the study. In the event that a participant contacts the trial staff because of concern about their depression or drinking and would like to access treatment, assistance will be provided.

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