A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study

Aliza Werner-Seidler, Kit Huckvale, Mark E. Larsen, Alison L. Calear, Kate Maston, Lara Johnston, Michelle Torok, Bridianne O'Dea, Philip J. Batterham, Susanne Schweizer, S. Rachel Skinner, Katharine Steinbeck, Julie Ratcliffe, Ju Lee Oei, George Patton, Iana Wong, Joanne Beames, Quincy J.J. Wong, Raghu Lingam, Katherine BoydellAllison M. Salmon, Nicole Cockayne, Andrew Mackinnon, Helen Christensen

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Abstract

Background: Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. Methods: A randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. Discussion: This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. Trial registration: Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

Original languageEnglish
Article number2
Number of pages21
JournalTrials
Volume21
Issue number1
DOIs
Publication statusPublished - 2 Jan 2020

Bibliographical note

Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Keywords

  • Adolescents
  • Cognitive behaviour therapy
  • Depression
  • Digital health
  • eHealth
  • Mental health
  • mHealth
  • Prevention
  • School
  • Smartphone application

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    Werner-Seidler, A., Huckvale, K., Larsen, M. E., Calear, A. L., Maston, K., Johnston, L., Torok, M., O'Dea, B., Batterham, P. J., Schweizer, S., Skinner, S. R., Steinbeck, K., Ratcliffe, J., Oei, J. L., Patton, G., Wong, I., Beames, J., Wong, Q. J. J., Lingam, R., ... Christensen, H. (2020). A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study. Trials, 21(1), [2]. https://doi.org/10.1186/s13063-019-3901-7