Developing and evaluating interventions and innovations

Children and Young People

A new methodology linking interactional and experiential approaches, and involving young people as co-analysts of mental health encounters

City St George’s Lead: Professor Rose McCabe

Funder: MRC Medical Research Council, £26,669.55

Duration: November 2022 to October 2024

Imagine that you are a researcher working on youth mental health. You know that adolescence and early adulthood are a critical period for intervention to prevent mental health problems continuing into adulthood. You want to understand why a substantial number of young people don't engage with, or don't benefit from, mental health interventions and services.

You might want to use 'qualitative' methods, because they are often better suited to capturing meaning, context and complexity. If you were curious about how interactions with services can sometimes go wrong for young people, this would be a good approach.

You could record what happens when young people do meet with professionals. You could analyse those conversations using an 'interactional' method. This focuses on how a particular social interaction unfolds - who says what, and where does that lead? But you would be lacking important contextual information about the meetings you recorded. For example, you wouldn't know how these events fitted into the broader story of the young person's attempts to get help, or how the young person felt about the event that you had just observed.

You could interview the young person instead, to find out about this context, and how they were feeling about their attempts to get help - what was it like for them? You could analyse these interviews using a 'phenomenological' method. This focuses on how people make sense of their experiences. But then you wouldn't be able to be very precise about what professionals should do differently, because you hadn't observed it.

There are two important and new features to the methodology which we propose to develop in this project. The first of those features is that we will combine these the approaches above, in order to show how a more powerful and insightful analysis of young people's experiences can be developed when we examine both what happens to young people when they seek help, and what they think and feel about that, in the context of their mental health needs. This may seem obvious, but these two methods are rarely - if ever - combined, and there is no methodological framework available for researchers to help them to think about how to combine them. We will do this, and then show how it can be done by others.

The second feature of our proposed new methodology is equally important. If you were a researcher preparing a new project, we hope that you would also be thinking about how to involve young people in planning, conducting, evaluating and sharing that project. You would find that there is plentiful guidance available about the general principles underlying this kind of collaboration. But there is no guidance (and there are very few published examples) which would help you to involve young people in analysing and interpreting data. This is the stage where researchers decide what they have found, and what it means, so it is very important.

We have found in our previous work, talking with young people about video data, that with appropriate preparation and support, young people will contribute very important analytic insights. We have shown already that the principles of this co-analysis are acceptable to young people, feasible for researchers, and produce valuable research. We want to expand on this and develop it, to meet the needs of the youth mental health research community.

By bringing other data sources (interviews) into the process, and showing how young people can engage with more than one form of analysis (phenomenological and interactional), we will develop a methodology that other researchers can use, in order that they can also co-analyse data with young people, and benefit from young people's expertise. These methodological developments will be transformative for the field of youth mental health research, enabling qualitative researchers to capture a much fuller picture of young people's experiences, and to work much more equitably alongside young people.

Find out more here: GtR

A Psychological Intervention to Reduce Suicidal Behaviour in Adolescence

City St George’s Lead: Professor Rose McCabe

Funder: Kavli Trust, £748,605.87

Duration: May 2022 to February 2026

Self-harm is a significant and growing concern for young people, their carers and clinical staff. Self-harm is the strongest predictor of suicide in adolescents. The prevalence rate of self-harm is 13.2% in 12–18-year-olds. When adolescents are referred to secondary child and adolescent mental health services (CAMHS), this offers a unique opportunity to intervene and change the young person’s future trajectory of suicidal behaviour. A recent systematic review identified that a brief psychological intervention comprising of therapeutic assessment, safety planning and solution-focused follow-up sessions are effective in reducing suicidal behaviour. This approach has been specifically adapted for young people and shown very promising results in reducing suicidal behaviour in a pilot study (English et al. 2019). It now needs to be tested in a definitive randomised controlled trial.

This project aims to reduce suicidal behaviour and improve quality of life in adolescents. It will evaluate the cost-effectiveness of a brief psychological intervention for adolescents presenting with self-harm in reducing suicidal behaviour.

Suicidal behaviour will be reduced in adolescents receiving the psychological intervention compared with those receiving treatment as usual.

Find out more here: Sash Study – Research trial study project to support adolescents with Self-Harm

Adolescent Mental Health and Development in the Digital World

City St George's Lead: Dr Mat Lucassen

Funder: MRC Medical Research Council, £5,579.27

Duration: September 2021 to August 2027

Adolescent Mental Health and Development in the Digital World (for brevity Digital Health) is co-led by Professors Chris Hollis and Ellen Townsend (Nottingham University). There are eight work packages and Mat and colleagues are conducting a randomised controlled trial of SPARX in Work Package 6. This consists of evaluating a digital form of cognitive behavioural therapy (CBT) in serious game format (i.e., SPARX) for adolescents with depression in England, in particular they are exploring SPARX with or without support from an e-coach (in this instance from an assistant psychologist). For more information about the study, see the published protocol: https://link.springer.com/article/10.1186/s40814-024-01475-7 and about SPARX refer to here: https://www.sparx.org.nz/

Find out more here: Digital Youth - nurturing young digital minds

Adults

OSMOSIS (Co-producing Social and coMmunity SuppOrt resources for family carers of people with psychosis)

City St George's Lead: Dr Jacqueline Sin

Funder: NIHR / DHSC Department of Health and Social Care, £521,179.18

Duration: September 2025 to February 2028

The programme – OSMOSIS – aims to co-produce resources and toolkits to improve the support available to family/informal carers for a relative affected by psychosis. The OSMOSIS programme comprises three work packages: (i) a service mapping exercise in three local boroughs across East London and East Sussex; (ii) a qualitative study using individual interviews with carers and focus groups with various staff to explore carers’ experiences of accessing social care support; and (iii) co-production and sharing of outputs with associated toolkits to improve and facilitate support for carers.

Find out more here: NIHR Research Programme for Social Care awards £7.5m across 14 projects | NIHR

Co-development of a primary care nurse-led intervention to enhance support for women with severe, debilitating premenstrual symptoms due to PreMenstrual Dysphoric Disorder (PMDD)

City St George’s Lead: Dr Sally Barlow

Co-Investigators: Sofia Llahana, Marie Hill, Asma Ashraf, Deborah Duncan

Funder: The Burdett Trust for Nursing, £67,843

Duration: September 2025 to August 2026

We aim to enhance the clinical pathway for women who seek help for debilitating premenstrual symptoms, also known as “Premenstrual dysphoric disorder (PMDD). Symptoms can include severe headaches, bloating, tearfulness, emotional lability and social withdrawal. These can significantly affect health and wellbeing, increase suicide risk and reduce productivity. The journey to diagnosis is often long and complex. Support primarily relies on consultations with general practitioners (GPs) whose knowledge of PMDD may be variable and time for assessments limited. Primary care nurses (PCNs) such as general practice nurses and advanced nurse practitioners are well-placed to assist with assessment and support, but their role remains under-recognized.

We will co-develop an innovative framework for nurse-led support for women with PMDD symptoms.

Objectives

1. Investigate women’s experiences, identifying perceived barriers and facilitators to receiving timely/appropriate treatment for PMDD in primary care.
2. Determine the perspectives of GPs, gynaecologists and psychiatrists caring for women with PMDD regarding the key roles of PCNs.
3. Assess PCNs’ knowledge of PMDD and their perceived roles within the clinical pathway.
4. Host two workshops with stakeholders to share findings, identify areas of action for PCNs, training needs and co-design a framework for nurse-led support.
5. Evaluate the framework with a wider group of GPs and PCNs.

MAP Trial (Metformin and psychosis weight prevention trial)

City St George's Lead: Dr Jacqueline Sin

Funder: NIHR / DHSC Department of Health and Social Care, £2,999,707.81

Duration: June 2025 to May 2029

The MAP trial aims to determine the clinical and cost effectiveness of metformin plus usual care compared to placebo plus usual care for preventing antipsychotic-induced weight hain in people with first episode psychosis.

Find out more here: Metformin and Psychosis Weight Prevention Trial (MAP Trial) - NIHR Funding and Awards

An exploration of the acceptability and usability of a health promotion theoretically underpinned checklist to enhance the development, implementation or evaluation of alcohol workplace policies (AWPs) and practices

City St George’s Lead: Lolita Alfred

Funder: City St George’s, University of London, £9,395.43

Duration: January 2023 to October 2024

Remote psychosocial interventions to prevent avoidable psychiatric hospital admissions in people with serious mental health problems (RAPID)

City St George’s Lead: Professor Steve Gillard

Funder: NIHR / DHSC Department of Health and Social Care

Duration: April 2022 to May 2025

People with serious mental health problems (SMHP) are more likely to be admitted to psychiatric hospital following contact with crisis services. Existing pressure on hospital beds is made worse by the extra impact on crisis care, and hospital admissions can be traumatic.

In the context of COVID-19, admitting someone to hospital can be additionally problematic. People with SMHP are vulnerable to COVID-19 due to an increased risk of underlying physical health problems, medication effects and difficulties engaging with mental health services. They may also introduce COVID-19 to the ward, or become infected on the ward, and Mental Health Trusts have to reduce number of beds in use to allow for infection prevention and control. As such, there is an urgent need for treatments to address suicidal thoughts and behaviours and, in turn, reduce avoidable hospital admissions.

Aims

To conduct a large, multi-site trial to find out which brief and remotely delivered treatments (those not delivered in person) are helpful for people with SMHP who have had recent suicidal thoughts or had a recent suicide attempt. The main question is whether the treatments are more effective in reducing hospital admissions over a 6 month period compared to usual treatment, and if these treatments provide value for money. We will also assess the impact on suicidal thoughts and behaviour, hope, recovery, anxiety and depression.

Design

We will carry out a trial that has four treatment conditions. All treatments will be delivered remotely. We will compare the following four treatment groups delivered for 3 months:

1. Structured peer support, which includes suicide prevention strategies based on cognitive behaviour therapy (CBT), delivered by peer support workers via telephone or video-conferencing.
2. A safety planning approach delivered over the telephone by assistant psychologists.
3. A CBT-based suicide prevention app for smartphones.
4. Treatment as usual

The group a service-user takes part in will be decided by chance. Recruitment will be based in Glasgow, Manchester, Oxford and London (East and North East). First, we will invite 200 people to participate in a smaller trial to see if there is interest for a study of this type. Depending on the results, we will then invite 1035 people to take part in the main trial.

To understand whether the trial and treatments are working, we would look at the results when 559 people have been recruited. This means that if one or more of the treatments is not helpful for people, it will be removed from the trial going forward. We will complete questionnaires with people when they start the study, at 3 months (end of treatment) and at 6 months (main outcome) to see if the treatments have been helpful.

Patient and Public Involvement

The Psychosis Research Unit Service User Reference Group (SURG) have provided feedback on the treatments and outcomes. Peer Support Workers have also provided feedback for the process and content of the treatment groups. Several of the research team have had diagnoses of SMHP and they will be part of the Trial Management Committee. A study-specific SURG will also oversee the running of the trial. Dissemination: We will present results with the support of the SURG at conferences, to user groups and NHS organisations. Results will be published using academic journals, training materials, social media and service-user led organisations. An accessible report will be published online.

Find out more here:  Remote psychosocial interventions to prevent avoidable psychiatric hospital admissions in people with serious mental health problems: a multi-arm multi-stage trial - NIHR Funding and Awards

The Clinical and Cost Effectiveness of Structured Psychological Support for People Diagnosed with a Personality Disorder: A Randomised Controlled Trial

City St George’s Lead: Dr Kirsten Barnicot

Team: Mike Crawford (Imperial College London), Verity C Leeson (Imperial College London), Rachel Evans (Bangor University),Nia Goulden (Bangor University), Tim Weaver (University of Middlesex), Aile Trumm ( (University of Middlesex) Barbara M Barrett (King College London), Fiona Khun-Thompson (Central & North West London NHS Foundation Trust),  Snehal P Pandya (Imperial College London),  Kate E Saunders (University of Oxford),  Gary Lamph (Keele University), David Woods (Derbyshire Healthcare NHS Foundation Trust), Harriet Smith (Avon and Wiltshire Mental Health Partnership NHS Trust), Toby Greenall (Lincolnshire Community Health Services NHS Trust), Victoria Nicklin (Coventry and Warwickshire Partnership NHS Trust).

Funder: NIHR / DHSC Department of Health and Social Care, £181,598.81

Duration: April 2022 to November 2024

Background. Evidence-based psychological treatments for people with personality disorder usually involve attending group-based sessions over many months. Low-intensity psychological interventions of less than 6 months duration have been developed, but their clinical effectiveness and cost-effectiveness are unclear.

Methods and analysis This was a multicentre, randomised, parallel-group, researcher-masked, superiority trial. Study participants were aged 18 and over, had probable personality disorder and were treated by mental health staff in seven centres in England. We excluded people who were: unwilling or unable to provide written informed consent, have a coexisting organic or psychotic mental disorder, or are already receiving psychological treatment for personality disorder or on a waiting list for such treatment. In the intervention group, participants were offered up to 10 individual sessions of Structured Psychological Support. In the control group, participants were offered treatment as usual plus a single session of personalised crisis planning. The primary outcome was social functioning measured over 12 months using total score on the Work and Social Adjustment Scale (WSAS). Secondary outcomes included mental health, suicidal behaviour, health-related quality of life, patient-rated global improvement and satisfaction, and resource use and costs. The primary analysis compared WSAS scores across the 12-month period using a general linear mixed model adjusting for baseline scores, allocation group and study centre on an intention-to treat basis. In a parallel process evaluation, we analysed qualitative data from interviews with study participants, clinical staff and researchers to examine mechanisms of impact and contextual factors.

Find out more here: Clinical effectiveness and cost-effectiveness of Structured Psychological Support for people with probable personality disorder in mental health services in England: study protocol for a randomised controlled trial - PubMed

Experience based investigation and co-design of approaches to prevent and reduce Mental Health Act use (CO-PACT)

City St George's Lead: Professor Rose McCabe (Co-I)

Team: Roisin Mooney (Queen Mary University of London, CI) and Kam Bhui (University of Oxford, CI)

Funder: National institute for Health Research £703,887

Duration: February 2021 to January 2023

Summary: The Mental Health Act allows professionals to admit people to hospital against their will. People from black and minority ethnic communities are more likely to get care this way. This can be distressing, reduces trust, and is costly.

We will work with mental health services in London, Manchester, Leeds, Birmingham, Bradford, Oxford and Derby. In each city, we will recruit 20 service users who have experienced at least one compulsory admission to hospital in the previous year. We will use a creative process involving photography to capture their experiences. The first meeting will explain the approach. We will ask people to take photos about their experiences of compulsory admission.

In two more meetings, we will ask people to add titles, captions, or descriptions to tell their stories. We want to know what may prevent compulsory care. The captions can be written, or audio or video recordings. Twenty mental health staff from across the seven cities will do the same. In each city, we will share this information with five service users, five carers and five staff members. Staff can be psychiatrists, psychologists, social workers, nurses, police, lawyers, commissioners, and policy experts. This group will meet three times and design a new approach, to reduce the number of people receiving compulsory care.

A fourth meeting will bring everyone together to consider their experience when they tried to apply the approach, specifically what works, for whom and how. We will ask everyone how they found working on the project using a questionnaire. They will be able to write freely. This will help us understand what helped and if anything changed for them. Using information about changes in care or practice, we will estimate costs and benefits.

Find out more here: NIHR project page: Experience based investigation and co-design of approaches to prevent and reduce Mental Health Act use (CO-PACT)

One-to-one peer support for family members and friends of patients treated under the Mental Health Act (OPAL)

City St George's Lead: Professor Rose McCabe (Co-I)

Team: Domenico Giacco (University of Warwick, CI).

Funder: National Institute for Health Research, £734,346.00

Duration: January 2021 to December 2023

The research aims to establish a new approach to support family and friends of patients treated under the Mental Health Act (MHA). Previous research has showed that most carers feel isolated and unsupported. They need help to overcome feelings of frustration and guilt and to restore relationships with their loved ones and services. Peer support among patients has proved to be popular and effective in mental health services with limited costs.

In this project we will explore how one-to-one carer peer support can be best provided to carers of people treated under the MHA in England. We will organise workshops and one-to-one interviews with carers, service users and clinicians to generate ideas on how one-to-one carer peer support can be delivered in England. We will then develop the training programme using a train the trainer model and test it in two stages. Experiences, costs, engagement of carers and carer peer supporters, quality of life of carers and any adverse events will be assessed. We will host workshops with key stakeholders: carers, users, professionals, academics, policy makers, and charities, to explore: a) how carer peer support can be organised and funded in England; b) how to test benefits and/or undesirable effects on a larger scale.

Find out more here: NIHR project page: One-to-one peer support for family members and friends of patients treated under the Mental Health Act (OPAL)

Older Adults

The 'Forget Me Not' approach: Co-producing accessible guidance videos for communicating and receiving a dementia diagnosis

City St George’s Lead: Professor Rose McCabe

Funder: NIHR / DHSC Department of Health and Social Care, £7,527.17

Duration: January 2023 to May 2024

This research project was co-designed by academics and the Forget Me Nots, three researchers living with dementia. The Forget Me Nots’ priority is improving the experience of people receiving a dementia diagnosis.

Unclear information about dementia at diagnosis causes uncertainty and anxiety. In a previous project, the study team video recorded 101 diagnosis feedback meetings and looked in detail at the communication. They found a challenge for clinicians in being clear about the impact of dementia while also providing hope for the future. There is little detailed guidance or advice available on how to communicate about a dementia diagnosis.

Find out more here: The 'Forget Me Not' approach: Co-producing accessible guidance videos for communicating and receiving a dementia diagnosis. - NIHR Funding and Awards

Dementia - Person Aligned Care Team

City St George’s Lead: Professor Rose McCabe

Funder: NIHR / DHSC Department of Health and Social Care, £140,221

Duration: October 2018 to February 2024

There are a variety of dementia support roles (Dementia Support Workers (DSWs); Dementia Navigators; Dementia Advisors) in different settings around the country. These roles can be clinical or non-clinical and designed to help people diagnosed with dementia and their carers, deal with the problems they might face. While they are valued highly there is lack of evidence as to what the best bits of support are, where it would be best delivered and whether or not it is cost effective. Commissioners and providers are therefore reluctant to invest fully in these services.

The Dementia-PACT programme aims to identify the most effective parts of good dementia support and test its delivery in GP practices. We will develop a DSW intervention, which provides ongoing support to tackle a range of needs of people with dementia and their carers: mental well-being; physical health; support to achieve social goals and improved quality of life. Supervised by experienced mental health care workers the DSWs will work alongside GPs and practice nurses and link to community resources.

We will train the DSWs to use a coaching approach to agree goals linked to personal priorities including future care decisions. We think this approach has the best chance to ensure physical health care is prioritised alongside other social and emotional needs. In years one and two, we will develop the theory of how such an intervention will work by reviewing the literature and talking to experts. We will then test this in a small trial in GP practices and get feedback so we can make improvements.

Previous trials have only recruited small proportions of people from GP settings. We will develop procedures for recruitment to ensure those who need the intervention most are not excluded. We will also test whether it is possible to recruit people with dementia who do not have a carer (who are often excluded from trials). Stakeholders will decide together the outcome measures used to evaluate the intervention. In years three to five we will run a larger trial with around 36 GP practices in 2-3 UK settings. We will split the practices equally between those that get the intervention and those that do not. We will measure differences in outcomes such as functioning, quality of life, carer well-being and cost.

Throughout the programme, we will look at how the intervention will work within the health and social care environment – in the trial and afterwards. This will help us understand how policy, organisations, training and commissioning can ensure the results of the research are used. We have brought together a team of people with the right skills and experience, including people with dementia and their carers to deliver the programme.

Find out more here:  Dementia - Person Aligned Care Team (D-PACT) - NIHR Funding and Awards