Nottingham Clinical Trials Unit

Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial (2023)
Preprint / Working Paper
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. Developing precision computerised cognitive behavioural therapy (cCBT) for adolescent depression: a pilot and feasibility protocol for the SPARX-UK trial

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

Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study (2023)
Journal Article
Iflaifel, M., Hall, C. L., Green, H. R., Willis, A., Rennick-Egglestone, S., Juszczak, E., Townsend, M., Martin, J., & Sprange, K. (2023). Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study. BMC Medical Research Methodology, 23(1), Article 211. https://doi.org/10.1186/s12874-023-02032-1

Background:

Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst participants in mental health r... Read More about Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study.

Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial (2023)
Journal Article
Subhani, M., Enki, D. G., Knight, H., Jones, K. A., Sprange, K., Rennick-Egglestone, S., Morling, J. R., Wragg, A., Hutton, C., & Ryder, S. D. (2023). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial. eClinicalMedicine, 61, Article 102069. https://doi.org/10.1016/j.eclinm.2023.102069

Background: Early identification followed by effective behaviour interventions is pivotal to changing the natural history of alcohol-related liver disease. We examined the feasibility of using transient elastography based advice and alcohol recovery... Read More about Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial.

Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study (2023)
Journal Article
Iflaifel, M., Sprange, K., Bell, J., Cook, A., Gamble, C., Julious, S. A., Juszczak, E., Linsell, L., Montgomery, A., & Partlett, C. (2023). Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study. Trials, 24, Article 71. https://doi.org/10.1186/s13063-022-06992-5

Background: Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, ther... Read More about Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study.

Mental health in clinically referred children and young people before and during the Covid-19 pandemic (2022)
Journal Article
Sayal, K., Partlett, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., Ewart, C., James, M., Lang, A., Sprange, K., & Montgomery, A. (2023). Mental health in clinically referred children and young people before and during the Covid-19 pandemic. European Child and Adolescent Psychiatry, 32(12), 2657–2666. https://doi.org/10.1007/s00787-022-02115-2

The Covid-19 pandemic and mitigation approaches, including lockdowns and school closures, are thought to have negatively impacted children and young people’s (CYP) mental health. However, the impact for clinically referred CYP is less clear. We inves... Read More about Mental health in clinically referred children and young people before and during the Covid-19 pandemic.

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units (2022)
Journal Article
Iflaifel, M., Partlett, C., Bell, J., Cook, A., Gamble, C., Julious, S., Juszczak, E., Linsell, L., Montgomery, A., & Sprange, K. (2022). Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units. Trials, 23(1), Article 535. https://doi.org/10.1186/s13063-022-06481-9

Background: Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statistic... Read More about Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units.

Embedding patient and public involvement in dementia research: Reflections from experiences during the ‘Journeying through Dementia’ randomised controlled trial (2022)
Journal Article
Beresford-Dent, J., Sprange, K., Mountain, G., Mason, C., Wright, J., Craig, C., & Birt, L. (2022). Embedding patient and public involvement in dementia research: Reflections from experiences during the ‘Journeying through Dementia’ randomised controlled trial. Dementia, 21(6), 1987-2003. https://doi.org/10.1177/14713012221106816

Background

The involvement of people with a diagnosis of dementia in patient and public involvement and engagement (PPIE) in research is an emerging field in the delivery of studies. Researchers need to understand and use the learning derived from... Read More about Embedding patient and public involvement in dementia research: Reflections from experiences during the ‘Journeying through Dementia’ randomised controlled trial.

Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing? (2022)
Journal Article
Mitchell, E. J., Sprange, K., Treweek, S., & Nixon, E. (2022). Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?. Trials, 23, Article 457. https://doi.org/10.1186/s13063-022-06417-3

Marketing is a core business function in commercial companies but is also frequently used by not-for-profit organisations. Marketing focuses on understanding what people value to make choices about engaging with a product or service: a concept also k... Read More about Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?.

STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial (2022)
Journal Article
Day, F., Wyatt, L., Bhardwaj, A., Dubicka, B., Ewart, C., Gledhill, J., James, M., Lang, A., Marshall, T., Montgomery, A., Reynolds, S., Sprange, K., Thomson, L., Bradley, E., Lathe, J., Newman, K., Partlett, C., Starr, K., & Sayal, K. (2022). STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial. BMJ Open, 12(5), Article e053043. https://doi.org/10.1136/bmjopen-2021-053043

INTRODUCTION: Emotional disorders (such as anxiety and depression) are associated with considerable distress and impairment in day-to-day function for affected children and young people and for their families. Effective evidence-based interventions a... Read More about STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial.

Outputs (43)