Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial

Abstract Background: A serious game (SPARX), developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression. However, SPARX has never been trialled in the United Kingdom (UK) and there have been issues relating to low engagement when it has been used in a real-world context. Aims: To conduct the first pilot and feasibility randomised controlled trial (RCT) in England to explore the use of SPARX in child and adolescent mental health services (CAMHS) and school-based Mental Health Support Teams (MHSTs). The trial will explore whether SPARX supported by an e-coach (assistant psychologists) improves adherence and engagement compared with self-directed use. The trial results will be used to inform optimal mode of delivery (SPARX supported vs. SPARX self-directed), calculate an appropriate sample size for a full RCT, and to decide which setting (CAMHS vs. MHSTs). Methods: A total of 120 adolescents (11-19 years) will be recruited for this three-arm study. Adolescents recruited from CAMHS and MHSTs across England will be randomised to receive either SPARX with human support (from an e-coach), SPARX self-directed or a waitlist control group. Assessments will be conducted online at baseline, week 4, and 8-10-weeks post-randomisation. The assessments will include measures which capture demographic, depression (Patient Health Questionnaire modified for adolescents [PHQ-A]) and anxiety (Revised Child Anxiety and Depression Scale [RCADS]) symptomatology, and health-related quality of life data (EQ-5D-Y and proxy version). Analyses will be primarily descriptive. Qualitative interviews will be undertaken with a proportion of the participants and clinical staff as part of a process evaluation, the qualitative data gathered will be thematically analysed. Finally, feasibility data will be collected on recruitment details, overall study uptake and engagement with SPARX, participant retention, and youth-reported acceptability of the intervention. Discussion: The findings will inform the design of a future definitive RCT of SPARX in the UK. If shown to be effective, an online serious game utilising CBT principles ultimately has the potential to improve the provision of care within the UK’s health services. Trial registration: ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.