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

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

doi:10.1186/s40814-024-01475-7

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

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

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	53
Journal	Pilot and Feasibility Studies
Volume	10
Issue number	1
DOIs	https://doi.org/10.1186/s40814-024-01475-7
Publication status	Published - 26 Mar 2024

Bibliographical note

The authors acknowledge the support of the UK Research and Innovation (UKRI) Digital Youth Programme award (Medical Research Council project reference MR/W002450/1) which is part of the AHRC/ESRC/MRC Adolescence, Mental Health and the Developing Mind programme. The Digital Youth Team are as follows: Chris Hollis, Ellen Townsend, Jo Gregory, Elvira Perez Vallejos, Rebecca Woodcock, Emma Nielsen, Peter Fonagy, Louise Arseneault, Sarah Doherty, Lucy-Paige Willingham, Cathy Creswell, Emily Lloyd, Josimar De Alcantara Mendes, Carolyn Ten Holter, Marina Jirotka, Praveetha Patalay, Yvonne Kelly, Aaron Kandola, Edmund Sonuga-Barke, Sonia Livingstone, Kasia Kostryka-Allchorne, Jake Bourgaize, Mariya Stoilova, Rory O'Connor, Dorothee Auer, Sieun Lee, Nitish Jawahar, Marianne Etherson, Chris Greenhalgh, Kapil Sayal, Jim Warren, Vajisha Wanniarachchi, Paul Stallard, Charlotte Hall, Mathijs Lucassen, Sally Merry, Karolina Stasiak, Camilla Babbage, Kareem Khan, Adam Parker, Holly Griffiths, Petr Slovak, Amy Jess Williams, and Joanna Lockwood. This research was supported by the NIHR Biomedical Research Centre Nottingham and the NIHR MindTech MedTech Co-operative. The views expressed are those of the authors and not necessarily those of the National Health Service, the National Institute for Health and Care Research, or the Department of Health and Social Care. Kapil Sayal is an NIHR Senior Investigator. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The authors would like to thank our PPI group Sprouting Minds, including the two co-chairs, Sarah Doherty and Lucy-Paige Willingham and Stuart Dodzo, Nkem Naeche, and Paul McClure for their valuable input on the design of our trial and refinement of the intervention. We would like to thank Adam Parker and Holly Griffiths and our three e-coaches, Matthew Jeffrey, Saskia Manzi, and Rachael Hooper as well as our previous e-coaches, Tayla Hurlock, and Emma Harrison. We would also like to thank Dr Maria Loades and Joanne Gregory for their fantastic support and helpful advice.

Data Availability Statement

Not applicable. The manuscript does not contain any data.

Keywords

Adolescents
CBT
Complex intervention
Depression
Digital intervention
Serious game

ASJC Scopus subject areas

Medicine (miscellaneous)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1186/s40814-024-01475-7Licence: CC BY

Cite this

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. (2024). Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK. Pilot and Feasibility Studies, 10(1), Article 53. https://doi.org/10.1186/s40814-024-01475-7

Khan, K, Hall, CL, Babbage, C, Dodzo, S, Greenhalgh, C, Lucassen, M, Merry, S, Sayal, K, Sprange, K, Stasiak, K, Tench, CR, Townsend, E, Stallard, P & Hollis, C 2024, 'Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK', Pilot and Feasibility Studies, vol. 10, no. 1, 53. https://doi.org/10.1186/s40814-024-01475-7

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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{\textquoteright}s health services if delivered en masse. Trial registration: ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.",

keywords = "Adolescents, CBT, Complex intervention, Depression, Digital intervention, Serious game",

author = "K. Khan and Hall, {C. L.} and C. Babbage and S. Dodzo and C. Greenhalgh and M. Lucassen and S. Merry and K. Sayal and K. Sprange and K. Stasiak and Tench, {C. R.} and E. Townsend and P. Stallard and C. Hollis",

note = "The authors acknowledge the support of the UK Research and Innovation (UKRI) Digital Youth Programme award (Medical Research Council project reference MR/W002450/1) which is part of the AHRC/ESRC/MRC Adolescence, Mental Health and the Developing Mind programme. The Digital Youth Team are as follows: Chris Hollis, Ellen Townsend, Jo Gregory, Elvira Perez Vallejos, Rebecca Woodcock, Emma Nielsen, Peter Fonagy, Louise Arseneault, Sarah Doherty, Lucy-Paige Willingham, Cathy Creswell, Emily Lloyd, Josimar De Alcantara Mendes, Carolyn Ten Holter, Marina Jirotka, Praveetha Patalay, Yvonne Kelly, Aaron Kandola, Edmund Sonuga-Barke, Sonia Livingstone, Kasia Kostryka-Allchorne, Jake Bourgaize, Mariya Stoilova, Rory O'Connor, Dorothee Auer, Sieun Lee, Nitish Jawahar, Marianne Etherson, Chris Greenhalgh, Kapil Sayal, Jim Warren, Vajisha Wanniarachchi, Paul Stallard, Charlotte Hall, Mathijs Lucassen, Sally Merry, Karolina Stasiak, Camilla Babbage, Kareem Khan, Adam Parker, Holly Griffiths, Petr Slovak, Amy Jess Williams, and Joanna Lockwood. This research was supported by the NIHR Biomedical Research Centre Nottingham and the NIHR MindTech MedTech Co-operative. The views expressed are those of the authors and not necessarily those of the National Health Service, the National Institute for Health and Care Research, or the Department of Health and Social Care. Kapil Sayal is an NIHR Senior Investigator. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The authors would like to thank our PPI group Sprouting Minds, including the two co-chairs, Sarah Doherty and Lucy-Paige Willingham and Stuart Dodzo, Nkem Naeche, and Paul McClure for their valuable input on the design of our trial and refinement of the intervention. We would like to thank Adam Parker and Holly Griffiths and our three e-coaches, Matthew Jeffrey, Saskia Manzi, and Rachael Hooper as well as our previous e-coaches, Tayla Hurlock, and Emma Harrison. We would also like to thank Dr Maria Loades and Joanne Gregory for their fantastic support and helpful advice.",

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T1 - Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression

T2 - a pilot and feasibility randomised controlled trial protocol for SPARX-UK

AU - Khan, K.

AU - Hall, C. L.

AU - Babbage, C.

AU - Dodzo, S.

AU - Greenhalgh, C.

AU - Lucassen, M.

AU - Merry, S.

AU - Sayal, K.

AU - Sprange, K.

AU - Stasiak, K.

AU - Tench, C. R.

AU - Townsend, E.

AU - Stallard, P.

AU - Hollis, C.

N1 - The authors acknowledge the support of the UK Research and Innovation (UKRI) Digital Youth Programme award (Medical Research Council project reference MR/W002450/1) which is part of the AHRC/ESRC/MRC Adolescence, Mental Health and the Developing Mind programme. The Digital Youth Team are as follows: Chris Hollis, Ellen Townsend, Jo Gregory, Elvira Perez Vallejos, Rebecca Woodcock, Emma Nielsen, Peter Fonagy, Louise Arseneault, Sarah Doherty, Lucy-Paige Willingham, Cathy Creswell, Emily Lloyd, Josimar De Alcantara Mendes, Carolyn Ten Holter, Marina Jirotka, Praveetha Patalay, Yvonne Kelly, Aaron Kandola, Edmund Sonuga-Barke, Sonia Livingstone, Kasia Kostryka-Allchorne, Jake Bourgaize, Mariya Stoilova, Rory O'Connor, Dorothee Auer, Sieun Lee, Nitish Jawahar, Marianne Etherson, Chris Greenhalgh, Kapil Sayal, Jim Warren, Vajisha Wanniarachchi, Paul Stallard, Charlotte Hall, Mathijs Lucassen, Sally Merry, Karolina Stasiak, Camilla Babbage, Kareem Khan, Adam Parker, Holly Griffiths, Petr Slovak, Amy Jess Williams, and Joanna Lockwood. This research was supported by the NIHR Biomedical Research Centre Nottingham and the NIHR MindTech MedTech Co-operative. The views expressed are those of the authors and not necessarily those of the National Health Service, the National Institute for Health and Care Research, or the Department of Health and Social Care. Kapil Sayal is an NIHR Senior Investigator. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The authors would like to thank our PPI group Sprouting Minds, including the two co-chairs, Sarah Doherty and Lucy-Paige Willingham and Stuart Dodzo, Nkem Naeche, and Paul McClure for their valuable input on the design of our trial and refinement of the intervention. We would like to thank Adam Parker and Holly Griffiths and our three e-coaches, Matthew Jeffrey, Saskia Manzi, and Rachael Hooper as well as our previous e-coaches, Tayla Hurlock, and Emma Harrison. We would also like to thank Dr Maria Loades and Joanne Gregory for their fantastic support and helpful advice.

PY - 2024/3/26

Y1 - 2024/3/26

N2 - 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.

AB - 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.

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KW - Complex intervention

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

Abstract

Bibliographical note

Data Availability Statement

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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