Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial

Sprange, Kirsty; Mountain, Gail; Craig, Claire

doi:10.1136/bmjopen-2020-043478

The clinical and cost effectiveness of a STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties (STADIA); multi- centre randomised controlled trial (2024)
Journal Article
Sayal, K., Wyatt, L., Partlett, C., Ewart, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., Lang, A., Sprange, K., Thomson, L., Moody, S., Holt, G., Bould, H., Upton, C., Keane, M., Cox, E., James, M., & Montgomery, A. (in press). The clinical and cost effectiveness of a STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties (STADIA); multi- centre randomised controlled trial. Journal of Child Psychology and Psychiatry,

Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study (2024)
Journal Article
Iflaifel, M., Hall, C. L., Green, H. R., Willis, A., Rennick-Egglestone, S., Juszczak, E., Townsend, M., Martin, J., & Sprange, K. (2024). Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study. Trials, 25, Article 596. https://doi.org/10.1186/s13063-024-08435-9

Background: Ensuring diversity in clinical trials can be a challenge, which may be exacerbated when recruiting vulnerable populations, such as participants with mental health illness. As recruitment continues to be the major cause of trial delays, re... Read More about Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study.

Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK (2024)
Journal Article
Barber, V. S., Calvert, C., Appelbe, D., Sprange, K., Nollett, C., Tanner, S., & Richards, D. B. (2024). Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK. Trials, 25(1), Article 224. https://doi.org/10.1186/s13063-024-08060-6

Background: Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. The range of media technology... Read More about Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK.

Choosing and evaluating randomisation methods in clinical trials: a qualitative study (2024)
Journal Article
Bruce, C. L., Iflaifel, M., Montgomery, A., Ogollah, R., Sprange, K., & Partlett, C. (2024). Choosing and evaluating randomisation methods in clinical trials: a qualitative study. Trials, 25(1), Article 199. https://doi.org/10.1186/s13063-024-08005-z

Background: There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with the choice of method, there is... Read More about Choosing and evaluating randomisation methods in clinical trials: a qualitative study.

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators (2024)
Journal Article
Papaioannou, D., Sprange, K., Hamer-Kiwacz, S., Mooney, C., Moody, G., & Cooper, C. (2024). Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators. Trials, 25(1), Article 163. https://doi.org/10.1186/s13063-024-07978-1

Background: Harms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); howe... Read More about Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators.

Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence (2024)
Journal Article
Papaioannou, D., Hamer-Kiwacz, S., Mooney, C., Cooper, C., O'Cathain, A., Sprange, K., & Moody, G. (2024). Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence. Journal of Clinical Epidemiology, 169, Article 111275. https://doi.org/10.1016/j.jclinepi.2024.111275

Objectives: Randomized controlled trials evaluate diverse interventions. This can include medical interventions such as drugs or surgical procedures, or behavior change interventions (BCIs) that aim to change a habit, belief, or attitude to improve h... Read More about Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence.

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).

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.

Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services (2023)
Journal Article
Rennick-Egglestone, S., Subhani, M., Knight, H., Jones, K. A., Hutton, C., Jackson, T., …Ryder, S. (2023). Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services. JMIR Formative Research, 7, Article e47109. https://doi.org/10.2196/47109

Background: Mortality from alcohol-related liver disease has risen significantly for three decades. Transient elastography (TE) is a non-invasive test providing a numerical marker of liver disease. Preliminary evidence suggests that receiving TE can... Read More about Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services.

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.

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.

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., …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.

An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT (2022)
Journal Article
Mountain, G., Wright, J., Cooper, C. L., Lee, E., Sprange, K., Beresford-Dent, J., Young, T., Walters, S., Berry, K., Dening, T., Loban, A., Turton, E., Thomas, B. D., Young, E. L., Thompson, B. J., Crawford, B., Craig, C., Bowie, P., Moniz-Cook, E., & Foster, A. (2022). An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT. Health Technology Assessment, 26(24), 1-152. https://doi.org/10.3310/khha0861

Background

There are few effective interventions for dementia.

Aim

To determine the clinical effectiveness and cost-effectiveness of an intervention to promote self-management, independence and self-efficacy in people with early-stage dement... Read More about An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT.

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.

All Outputs (40)