Abstract
BackgroundDepression 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.MethodsA 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.DiscussionThis 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 registrationAustralian 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.
Highlights
Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years
The prevention of depression is critical if the burden of disease is to be reduced
This study will be the first to examine the prevention of depression in young people at scale, using easy-to-access, convenient and private mobilephone applications
Summary
Trial design This study is a randomised controlled, single-blind trial with two intervention stages, each consisting of two parallel arms (intervention and inactive control) with 1:1 allocation at each stage. Previous studies have demonstrated that this instrument has adequate internal consistency and validity [80, 81] In this trial, the complete BRFSS-ACE will be administered at 48-month follow-up when participants are near 18 years of age. This group will be responsible for monitoring the efficacy of the interventions being tested on primary outcomes, as well as the overall conduct of the study, including recruitment, protocol compliance, accuracy and completeness of data collection This group will provide recommendations with respect to continuing, modifying or terminating the trial, on the basis of feasibility or safety concerns, and will have access to unblinded data. The primary analysis will be conducted using planned contrasts comparing a change in depression scores on the PHQ-A from baseline to 12 months between the trial arms (SPARX intervention vs control), using a mixed-effects model repeated-measure analysis (MMRM). No restrictions have been imposed on the dissemination of information by funders
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