Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK

Khan, K.; Hall, C. L.; Babbage, C.; Dodzo, S.; Greenhalgh, C.; Lucassen, M.; Merry, S.; Sayal, K.; Sprange, K.; Stasiak, K.; Tench, C. R.; Townsend, E.; Stallard, P.; Hollis, C.

Abstract

Background : A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally 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 in studies undertaken in Australasia. 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 different settings. The trial will explore whether SPARX supported by an e-coach (assistant psychologists) improves adherence and engagement compared with self-directed (i.e. self-help) use. The trial results will be used to inform the optimal mode of delivery (SPARX supported vs. SPARX self-directed), to calculate an appropriate sample size for a full RCT, and to decide which setting is most suitable. Methods: Following consultation with young people to ensure study suitability/appropriateness, a total of 120 adolescents (11–19 years) will be recruited for this three-arm study. Adolescents recruited for the study across England will be randomised to receive either SPARX with human support (from an e-coach), self-directed SPARX, or a waitlist control group. Assessments will be conducted online at baseline, week 4, and 8–10-week 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, and 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 the subsequent definitive RCT demonstrates that SPARX is effective, then an online serious game utilising CBT principles ultimately has the potential to improve the provision of care within the UK’s health services if delivered en masse. Trial registration: ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.

• Journal Article Type: Article
• Acceptance Date: Mar 12, 2024
• Online Publication Date: Mar 26, 2024
• Publication Date: Mar 26, 2024
• Deposit Date: Mar 26, 2024
• Publicly Available Date: Mar 26, 2024
• Journal: Pilot and Feasibility Studies
• Electronic ISSN: 2055-5784
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 10
• Issue: 1
• Article Number: 53
• DOI: https://doi.org/10.1186/s40814-024-01475-7
• Keywords: Depression, Complex intervention, CBT, Digital intervention, Serious game, Adolescents
• Public URL: https://nottingham-repository.worktribe.com/output/33020104
• Publisher URL: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-024-01475-7
• Additional Information: Received: 17 July 2023; Accepted: 12 March 2024; First Online: 26 March 2024; : ; : The SPARX-UK trial obtained ethical approval from the South West-Cornwall & Plymouth Research Ethics Committee on 15 December 2022 (Ethics Ref.: 22/SW/0149).; : Not applicable; : The intellectual property for SPARX is held by UniServices at the University of Auckland. Any proceeds from licensing or selling SPARX outside of New Zealand will be shared in part with UniServices and Sally Merry, Karolina Stasiak, Mathijs Lucassen, and two other co-developers (not involved in the current study). Kapil Sayal was an Expert Panel Member for the NICE Depression in Children and Young People Guideline Update Committee (CG28). The other authors declare that they have no competing interests.