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All Outputs (45)

Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK (2024)
Journal Article

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.

Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK (2024)
Journal Article

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

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

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

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

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).

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

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.

Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study (2023)
Journal Article

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

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

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

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.

Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing? (2022)
Journal Article

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

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

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

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

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

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

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.