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

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.

Protocol for the process evaluation of a complex intervention delivered in schools to prevent adolescent depression: the Future Proofing Study

“…The FPS is a large school-based trial examining whether depression can be prevented using cognitive-behavioural therapy (CBT) delivered by smartphone application. 5 There has been an increase in the availability of digital mental health programmes which show promise in addressing the significant disease burden associated with depression. 6 Depression often first emerges during adolescence 7 and treatment alone cannot adequately reduce this burden.…”

“…More details are available from the Australian New Zealand Clinical Trials Registry and protocol paper. 5 The intervention being delivered is known as SPARX, a CBT-based programme incorporating gamification principles. The development and initial evaluation of SPARX have been documented in detail previously.…”

“…The FPS is a large school-based trial examining whether depression can be prevented using cognitive–behavioural therapy (CBT) delivered by smartphone application. 5 …”

“…More details are available from the Australian New Zealand Clinical Trials Registry and protocol paper. 5 …”

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“…The main diagnostic methods for COVID-19 are: (i) nucleic acid detection. This method not only has high requirements for test equipment, but also high requirements for laboratory cleanliness and operators ( Lerner et al., 2020 ). The quality of sample collection could directly affect the test results.…”