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All Outputs (31)

Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK (2024)
Journal Article
Khan, K., Hall, C. L., Babbage, C., Dodzo, S., Greenhalgh, C., Lucassen, M., …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, Article 53. https://doi.org/10.1186/s40814-024-01475-7

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

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs) (2023)
Journal Article
Madurasinghe, V. W., Knapp, P., Eldridge, S., Collier, D., Treweek, S., Rick, J., …Bower, P. (2023). Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs). BMC Medicine, 21(1), Article 425. https://doi.org/10.1186/s12916-023-03081-5

Background: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the... Read More about Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs).

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., …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 resea... 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., …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., …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., …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., …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.

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., …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.

The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial (2022)
Journal Article
Mountain, G., Cooper, C., Wright, J., Walters, S., Lee, E., Craig, C., …Young, E. (2022). The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial. Lancet Healthy Longevity, 3(4), e276-e285. https://doi.org/10.1016/S2666-7568%2822%2900059-9

Background There is an urgent clinical need for evidence based psychosocial interventions for people with mild dementia. We aimed to determine clinical and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote w... Read More about The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial.

The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention (2021)
Journal Article
Berry, K., Wright, J., Sprange, K., Cooper, C., Courtney-Walker, R., & Mountain, G. (2021). The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention. Brain and Behavior, 11(12), Article e2436. https://doi.org/10.1002/brb3.2436

Objective: A key challenge in delivering pragmatic trials of complex interventions is effective implementation within the study period and beyond. We describe a trial of an intervention to improve quality of life in mild dementia (Journeying through... Read More about The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention.

Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial (2021)
Journal Article
Subhani, M., Jones, K. A., Sprange, K., Rennick-Egglestone, S., Knight, H., Morling, J. R., …Ryder, S. D. (2021). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial. BMJ Open, 11(11), Article e054954. https://doi.org/10.1136/bmjopen-2021-054954

Introduction Heavy drinkers in contact with alcohol services do not routinely have access to testing to establish the severity of potential liver disease. Transient elastography by FibroScan can provide this information. A recent systematic review su... Read More about Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial.

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial (2021)
Journal Article
Sprange, K., Mountain, G., & Craig, C. (2021). Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial. BMJ Open, 11(4), Article e043478. https://doi.org/10.1136/bmjopen-2020-043478

Objectives: Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a det... Read More about Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial.

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial (2021)
Journal Article
Sprange, K., Mountain, G., & Craig, C. (2021). Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial. BMJ Open, 11(4), Article e043478. https://doi.org/10.1136/bmjopen-2020-043478

Objectives: Robust research of complex interventions designed to promote mental wellbeing in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a deta... Read More about Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial.

Promoting independence in Dementia (Pride): A feasibility randomized controlled trial (2021)
Journal Article
Csipke, E., Shafayat, A., Sprange, K., Bradshaw, L., Montgomery, A. A., Ogollah, R., …Orrell, M. (2021). Promoting independence in Dementia (Pride): A feasibility randomized controlled trial. Clinical Interventions in Aging, 16, 363-378. https://doi.org/10.2147/CIA.S281139

© 2021 Csipke et al. Background: There is a need for interventions to foster and maintain independence for people with dementia to support community living, improve morale, and reduce stigma. We investigated a social intervention to promote living we... Read More about Promoting independence in Dementia (Pride): A feasibility randomized controlled trial.

Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Craig, C., Mason, C., Berry, K., …Cooper, C. (2021). Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial. BMC Geriatrics, 21, Article 119. https://doi.org/10.1186/s12877-021-02070-8

Background Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part of a trial of a complex... Read More about Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial.

Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Craig, C., Mason, C., Berry, K., …Cooper, C. L. (2021). Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial. BMC Geriatrics, 21(1), Article 119. https://doi.org/10.1186/s12877-021-02070-8

© 2021, The Author(s). Background: Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part... Read More about Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial.

Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Thomas, B., Wright, J., Mason, C., & Cooper, C. L. (2021). Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists. Clinical Interventions in Aging, 16, 231-244. https://doi.org/10.2147/cia.s293921

Objectives: To identify the barriers and facilitators to the implementation of a complex psychosocial intervention though a study exploring the experiences of participants, carers and interventionists during a trial Methods: Individual semi-struct... Read More about Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists.

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI) (2020)
Journal Article
Husbands, S., Elliott, D., Davis, T. R., Blazeby, J. M., Harrison, E. F., Montgomery, A. A., …Mills, N. (2020). Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI). Pilot and Feasibility Studies, 6(1), https://doi.org/10.1186/s40814-020-00710-1

© 2020, The Author(s). Background: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome r... Read More about Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI).

Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials (2020)
Journal Article
Mitchell, E. J., GODOLPHIN, P., Meakin, G., & Sprange, K. (2020). Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials. Trials, 21, https://doi.org/10.1186/s13063-020-04465-1

© 2020 The Author(s). Background: Poor recruitment in clinical trials is well-documented. In large, multi-centre trials, communication between the coordinating centre and trial sites is essential. A commonly used communication tool is the hosting of... Read More about Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials.