Approved NHS Projects

Healthcare Organisation: Nottinghamshire Healthcare NHS Foundation Trust
Chief Investigator’s Organisation: University of Birmingham
Chief Investigator: Professor Steven Marwaha
Start date: 11/05/2026

COMBINER is a pragmatic, observer-blind, multi-centre, 3-arm, parallel group randomised controlled trial (RCT) with an internal pilot and full economic evaluation. The aim of the study is to evaluate the clinical and cost-effectiveness of combination lithium and quetiapine therapy compared with lithium or quetiapine alone for maintenance treatment in adults with bipolar disorder (BD)

Healthcare Organisation: Birmingham and Solihull Mental Health NHS Foundation Trust
Chief Investigator’s Organisation: Birmingham and Solihull Mental Health NHS Foundation Trust / University of Birmingham
Chief Investigator: Benjamin Perry
Start date: 05/05/2026

Young people with mental health conditions such as depression, bipolar disorder, and anxiety are at an increased risk of developing physical health problems, including weight gain, diabetes, and heart disease. These conditions can reduce life expectancy and place a significant burden on individuals and healthcare systems. Identifying those at highest risk early on is important so that preventative steps, such as lifestyle support or careful treatment choices, can be offered in time.
Most existing tools used to predict future physical health risks are designed for the general population and are not deemed accurate for young people with mental health conditions. A newer tool, called the Psychosis Metabolic Risk Calculator (PsyMetRiC), was developed specifically for young people with psychosis and has been shown to predict metabolic risk more accurately in this group. However, is is not yet known whether this tool works well for young people with other common mental health conditions, such as depression, bipolar disorder, or anxiety.

This study aims to test whether PsyMetRic can be reliably used in young people aged 14-35 with mood and anxiety disorders. To do this, we will use anonymised electronic health records from mental health services in Birmingham and Solihull. These records include routinely collected information such as diagnoses, physical health measurements, blood test results, and prescribed medications. We will assess how well the tool predicts three important outcomes: metabolic syndrome, type 2 diabetes, and significant weight gain. We will also examine whether the tool performs equally well across different patient groups defined by sex, ethnicity, or diagnosis. If the tool does not perform well, we will explore ways to adjust it to improve its accuracy. The findings of this study will help determine whether an existing risk prediction tool can be extended to a broader group of young people with mental health conditions. In the long term, this could support more personalised care by helping clinicians identify individuals at higher risk earlier and take steps to prevent serious physical health complications.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator: Anna-Marie Marshall
Start date: 01/05/2026

Evidence indicates that many individuals entering secondary care are experiencing social distress. We are conducting a pilot study to identify and characterise key social determinants driving suicide and suicide behaviour among people in the North East of England. The data is required to examine how these determinants may lead to and interact to contribute to distress, despair, self-harm, and suicidality.

Many people referred to specialist mental health services are facing serious social challenges that may be affecting their wellbeing. This pilot study aims to explore the main social factors linked to suicide and suicidal behaviour among people in the North East of England. By gathering this information, the study hopes to better understand how issues such as financial hardship, housing problems, loneliness, or unemployment may combine to increase distress, hopelessness, self-harm, and suicidal thoughts or actions. The findings will help identify where support may be needed to prevent people from reaching crisis point.

Healthcare Organisation: South West London & St. George’s Mental Health NHS Trust
Chief Investigator’s Organisation: University of Cambridge
Chief Investigator: Dr Graham Murray
Start date: 24/04/2026

We aim to develop a longitudinal representative study that will allow researchers to identify ways to help earlier identification, treatment and prevention of emerging psychosis patients. Patients who have had a least one episode of psychosis or identified as being at risk of psychosis will be invited to participate in the study. Controls will also be recruited. Participants will be invited to give a blood sample, and a researcher will ask them questions from a set of questionnaires. Patients (but not controls) will also be asked to complete questionnaires via electronic means (online or via a phone app once launched). They will answer these questions shortly after their initial appointment at least every six months for a duration of up to 3 years. If participants are unable to give blood (e.g. for clinical reasons) then saliva may be used instead. If patients do not have access to smartphone or wish not to use the phone app on their personal phone (once launched), then with agreement with the researcher, the researcher may take on the responsibility of inputting the data on the patient’s behalf. If patients do not enter information at the six-month interval, a searcher may get in touch with them to remind them,. Participants are welcome to withdraw at any point in the study. A full explanation of how their data is managed is provided in the Participant Information Sheet. They may be asked the reason(s) for their withdrawal to improve future studies. By participating, participants will allow researchers to learn more about the genetic sequence, chemical makeup, protein makeup, and the body’s natural defence system, to facilitate new research to drive improvements in the early diagnosis and treatment of psychosis. This will allow future studies to drive forward preventive approaches and new treatments.

Healthcare Organisation: South West London & St. George’s Mental Health NHS Trust
Chief Investigator’s Organisation: South West London & St. George’s Mental Health NHS Trust
Chief Investigator: Dr Robert Lawrence
Start date: 19/03/2026

Persecutory delusions (inaccurate beliefs that others intend to harm you) (e.g. “MI5 and the police are trying to torture me” “My neighbours are out to get me and are spreading nasty gossip”) are very common in severe mental health disorders such as schizophrenia. People withdraw from everyday life. This seriously affects their mental and physical health.

Existing treatments often don’t work well enough. In the UK 150,000 NHS patients experience these distressing thoughts despite treatment. This is why we developed the Feeling Safe programme. It is the outcome of fifteen years of research and clinical practice. We recently tested Feeling Safe in a clinical trial with 130 patients with persistent persecutory delusions. The treatment was delivered by clinical psychologists over 20 sessions. Half of people achieved large benefits. Another quarter made moderate gains. These results provide great cause for optimism in the treatment of delusions.

The challenge now is to make Feeling Safe widely available. So, we have created a six-month guided online version that users can access whenever they choose via smartphone/computer/or tablet. A range of mental health workers can support the delivery of the treatment over six months (both remotely and face-to-face). Six face-to-face sessions will be reserved for a key task: going out with patients into everyday situations to relearn safety. The new programme is called Feeling Safer.

Healthcare Organisation: South West London & St. George’s Mental Health NHS Trust
Chief Investigator’s Organisation: South West London & St. George’s Mental Health NHS Trust
Chief Investigator: Dr Robert Lawrence
Start date: 19/03/2026

There are many types of dementia. This research studies the family of illnesses known as Frontotemporal type of dementia. This devastating group of illnesses change behaviour, language, and movement. Frontotemporal dementia often affects younger adults and runs in families. There is long running inflammation in the brain with Frontotemporal dementia- suggesting that anti-inflammatory treatments may slow or prevent decline. However, no two people are the same in their symptoms, or in what drives inflammation. For example, genetics, lifestyle, ethnicity and the immune system will affect the disease. Understanding these differences is crucial for new therapies.

Current ways to measure brain inflammation are invasive (spinal fluid) or very expensive (brain scans). We have discovered that special blood tests can also detect inflammation in Frontotemporal dementia. But these need to be tested in “real-world” settings, with people of all backgrounds.

We have set up a national study that aims to involve people with Frontotemporal dementia, collecting blood samples from specialist and non-specialist NHS clinics, including communities and remote areas that are too often under-represented in research. We will measure blood inflammation and look at genetic and environmental factors that influence it. Data will be securely shared with other research teams via the Dementias Platform UK. We will arrange sessions to engage people with dementia, carers, professionals, and people across diverse communities.

This project will find the best way to measure inflammation in people with Frontotemporal dementia, and its causes. The open network will also build collaborations and trusted relationships to facilitate clinical trials of new drugs.

Healthcare Organisation: Hampshire and Isle of Wight Healthcare NHS Foundation Trust
Chief Investigator’s Organisation: Hampshire and Isle of Wight Healthcare NHS Foundation Trust
Chief Investigator: Joe Salmon
Start date: 13/02/2026

Visual Hallucinations are the perception of visual stimuli without an external source, experienced by individuals with a variety of conditions. They impact daily functioning and emotional well-being. Studies have found staff attitudes towards VHs vary based on professional, educational and cultural factor which influence diagnosis and care. We aim to investigate the prevalence of VHs within the UK within the ICD-10 F20-F29 and first episode psychosis population. Via the use of the CRIS platform, we will extrapolate the prevalence of visual hallucinations within the UK.

Healthcare Organisation: South West London & St. George’s Mental Health NHS Trust
Chief Investigator’s Organisation: South West London & St. George’s Mental Health NHS Trust
Chief Investigator: Dasha Isaeva
Start date: 09/02/2026

National legislation has mandated regular training for healthcare professionals to improve their understanding of autism. Healthcare professionals should be alert for possible signs of autism and use screening questionnaires when autism is suspected. Referral to autism diagnosis services must be offered if the person wants an autism assessment and/or it may improve their care. Reasonable adjustments must be made when working with autistic adults. North and South Kingston Integrated Recovery Hubs are two community mental health teams that provide access to specialist treatments to support adults with severe mental health difficulties. Clinicians in these teams have anecdotally reported high levels of suspected or diagnosed autism amongst the people they see. However, the exact prevalence is unknown. It is also unknown how many people with suspected autism are being screened and/ or referred for assessment. It is also unknown how many people with diagnosed autism are receiving reasonable adjustments. This audit aims to answer these questions and determine whether adults with suspected and diagnosed autism as receiving equitable care and healthcare professionals in the teams are adhering to national guidelines

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator: Susanna Mills
Start date: 01/02/2026

To complete the study we will explore weight change (i.e., loss/ gain) using pseudo-anonymised retrospective 5-year linked data from two cohorts of individuals with a mental health disorder or learning disability.

Weight changes, especially weight gain, during an admission to a mental health hospital is almost seen as inevitable, due to obesogenic effect of medication, low levels of physical activity, body dysmorphia and disordered eating habits. As a result, individuals may gain excessive amounts of weight impacting self-esteem, mood and increasing the risk of co-morbidities such as cardiovascular disease and diabetes. There is a paucity of information relating to body habitus change over time or the scale of the problem. Although weight and height are measured on admission, and nutrition screening tools available, they usually need a healthcare professional to manually complete the nutrition screen and refer to a nutrition professional for dietary support, which may not always be done. Individuals with a mental health disorder or learning disability have an increased risk of excess weight. Obesity has a big impact on health and social care systems and is a leading reason for lower healthy life expectancy. This study aims to explore weight changes over time across two mental health hospitals using pseudoanonymised data; to describe the scale of the problem, factors associated with weight changes and potential time points for future dietary, physical activity and psychosocial intervention for patients and staff to improve health outcomes.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator: Sarah Garner
Start date: 22/01/2026

The aim of the trial is to evaluate the clinical and cost-effectiveness of combination lithium and quetiapine therapy compared with lithium or quetiapine alone for maintenance treatment in adults with bipolar disorder (BD).

Healthcare Organisation:Oxford Health NHS Foundation Trust
Chief Investigator’s Organisation: University of Oxford
Chief Investigator: Dominic Oliver
Start date: 20/01/2026

Primary indicated prevention is a key target for reducing the incidence and burden of schizophrenia and related psychotic disorders. An individualised, clinically-based transdiagnostic model for the detection of individuals at risk of psychosis was developed in South London and previously validated in Oxford Health, showing good performance. It has since been improved with the addition of 14 natural language processing (NLP) symptom and substance use predictors but the generalizability of this refined model is unknown. This study aims to perform an external validation of the NLP-refined transdiagnostic risk calculator for psychosis.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator: Dr Zeid Mohammed
Start date: 20/01/2026

The purpose of this research study is to compare the effects of ALTO-100, the study’s investigational drug, versus a placebo in treating the symptoms of depression in participants who have bipolar with depression and who are also taking mood stabilizers and/or a typical anti psychotic.

Healthcare Organisation: Oxford Health NHS Foundation Trust
Chief Investigator’s Organisation: Oxford Health NHS Foundation Trust
Chief Investigator: Dr Alvaro Barrera
Start date: 06/01/2026

People sometimes experience sudden episodes of psychosis, where they may hear voices, hold strong unusual beliefs or feel very confused, but then recover fully within a short period of time. These brief psychotic episodes can be very distressing, and at the moment we do not fully understand why they happen in some individuals.

Some reports suggest that viral infections such as flu or COVID-19 might trigger psychotic symptoms in a small number of people, possibly because of the way the body’s immune and inflammatory systems respond to infection. However, it is still unclear how common this is and whether there may be a specific group of patients whose brief psychotic episode follows a recent viral illness.

This study will use the Clinical Record Interactive Search (CRIS) system, which allows researchers to look at anonymised information from Oxford Health NHS Foundation Trust’s electronic records. We will identify patients aged 14 and above who were admitted to mental health wards over the last ten years with a brief psychotic episode. We will then look at their anonymised records to see how often there is mention of a recent viral infection, viral-like symptoms such as fever or cough, and blood tests that suggest infection or inflammation around the time they became unwell.

No patients will be contacted and no changes will be made to anyone’s care. All information is de-identified before researchers see it, and the work is carried out under strict data protection and confidentiality rules. By understanding whether viral illnesses commonly occur around the time of brief psychosis, we hope to inform future research and, in the long term, help clinicians to better recognise and manage this potential subgroup of patients.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator: Rob Dudley
Start date: 30/11/2025

Visions are the experience of seeing things that other people cannot. Up to two thirds of people with Psychosis report visions. Psychosis is a term for a number of conditions where people are distressed by seeing, hearing, or believing things that other people do not. People with visions tell us that they:

• don’t understand why they see them,
• feel different from others,
• find these experiences to be frightening,
• find it hard to manage everyday activities.

Currently there are no proven treatments to help people deal with their visions.

We want to develop and test a new treatment in which an experienced therapist helps people understand what can cause visions, that other people have similar experiences and that they do not need to be afraid. The person then learns to manage their visions differently using virtual reality. This helps the person build the confidence to try different ways of managing their visions.

To test it we will ask 16 people with visions attending psychosis services to:

• come to 4-6 sessions that help to explain why people have visions and introduces new coping strategies to manage visions,
• have 4-6 sessions of virtual reality therapy,
• complete assessments before the therapy sessions start, halfway through therapy (6 weeks), and after therapy has finished (12 weeks, and 16 weeks).

The main goal is to reduce the distress and impact of the visions. We will also undertake in depth interviews to help understand how to improve the treatment.

This study has been developed with people with lived experience. A lived experience advisory panel will be involved in all aspects of the project. Two co-applicants with lived experience of visions, psychosis and using mental health services will support the study and the public and patient involvement element of the research.

Healthcare Organisation: Nottinghamshire Healthcare NHS Foundation Trust
Chief Investigator’s Organisation: Coventry and Warwickshire Partnership NHS Trust
Chief Investigator: Dr Steven Marwaha
Start date: 13/11/2025

To evaluate the clinical and cost-effectiveness of stimulant (Lisdexamfetamine) compared with non-stimulant (Atomoxetine) medication for adults with Attention-Deficit/Hyperactivity Disorder (ADHD) and a history of either psychosis or bipolar disorder.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Newcastle University
Chief Investigator: Paul Donaghy
Start date: 10/11/2025

Depression has been shown to be associated with dementia in population-based studies. A history of depression is associated with double the risk of developing dementia compared with people who have not had depression.

The onset of a first episode of depression in later life may represent prodromal symptoms of dementia. A CRIS study based in the South London and Maudsley NHS Foundation Trust found that 22% of people with late life depression (onset>65 years) developed dementia with a mean follow-up of 2.7 years. The risk was higher for those with no previous history of depression.

In preparation for future cohort studies in late onset depression, we will replicate these findings in the CNTW CRIS system, with the following aims:
1. Identify the proportion of people in secondary care with very late onset depression who develop dementia
2. Identify clinical predictors of dementia
3. Identify whether those who develop dementia have evidence of lower responsiveness to antidepressant medications (e.g. more trials of different antidepressants, longer episodes under secondary care, more admissions to hospital, less resolution of symptoms)

This will provide important information that will be published in a peer reviewed journal, and will also form pilot data for future grant applications for observational clinical studies in this area.

Healthcare Organisation: Oxford Health NHS Foundation Trust
Chief Investigator’s Organisation: Oxford Health NHS Foundation Trust
Chief Investigator: Jane Boydell
Start date: 24/09/2025

Compulsory nasogastric feeding usually involves the physical restraint of patients by several staff members to insert a narrow bored tube into the nose, through a hole in the back of the nose and into the stomach. After checking that the tube is in the stomach, a nutritionally dense liquid feed can be administered. This can be life saving when a patient with an eating disorder is a very low weight and unable to improve their nutritional status by eating or drinking.

The procedure can be highly distressing and sedation is rarely offered. PTSD symptoms (nightmares, flashbacks, feeling on edge). have been reported. Concerns have also been raised about retraumatising people who have suffered assault (who unfortunately make up a significant proportion of patients with eating disorders). Sadly the fear of nasogastric feeding has led to avoidance of care that could have treated the eating disorder.

No studies, to our knowledge, have systematically investigated how many people develop PTSD symptoms, following compulsory nasogastric feeding. A large scale study is needed to answer this question and to establish what factors predict the development of these symptoms and whether the use of sedation prevents it.

The proposed study is to use the CRIS facility to anonymously and electronically scan case notes, for reports of PTSD symptoms, the severity and impact of these symptoms. A further analysis will test a range of factors that might make a person more likely to develop PTSD and if possible whether sedation reduces the risk.

Healthcare Organisation: South West London and St George’s Mental Health NHS Trust
Chief Investigator’s Organisation: South West London and St George’s Mental Health NHS Trust
Chief Investigator: Dr Andrew White
Start date: 05/08/2025

Neither the DSM-5 diagnosis of borderline personality disorder (APA, 2013), nor its rough equivalent in Europe, the ICD-10’s diagnosis of emotionally unstable personality disorder (impulsive or borderline type; WHO, 2004), feature voice-hearing as one of their criteria. The ICD-11 (WHO, 2018) will not defer from this picture when it comes into common usage in the future.

However, voice-hearing is frequently experienced by people with these diagnoses (e.g. Beatson, 2019). When meeting such presentations, clinicians seemingly must navigate a choice: whether to construe voice-hearing as an additional symptom of these diagnoses (though it is not featured in the diagnostic criteria), or to view such voice-hearing as consistent with a co-occurring psychotic disorder (even in the absence of additional psychotic symptoms). This initial choice impacts upon subsequent treatment, and particularly medication, choices.

This study will explore how clinicians in SWLSTG navigate these choices in relation to voice-hearing in service users with a diagnosis of emotionally unstable personality disorder, through a Thematic Analysis of notes in this area.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator: Aditya Sharma
Start date: 30/07/2025

Sleep Buddy was developed by parents and carers of children with ADHD working with sleep experts. It has personalised information and advice on how primary caregivers can manage their child’s sleep problems with videos and top tips from other parents. We are wanting to use CRIS to increase recruitment in a cohort with infrequent appointments to allow for successful recruitment in the timescale.

Healthcare Organisation: South West London and St George’s Mental Health NHS Trust
Chief Investigator’s Organisation: South West London and St George’s Mental Health NHS Trust
Chief Investigator: Megan Cartier
Start date: 15/07/2025

The study will look at instances of marriage and divorce within individuals with psychosis-spectrum disorders. There is evidence in the literature that individuals with these diagnoses have increased difficulties engaging in romantic relationships, thus impacting rates of marriage within this population. There is a gap in literature surrounding any demographic differences in individuals who do get married and have these diagnoses. Therefore, the current study aims to examine the ethnicity and gender differences in relation to marital status within this population.

Healthcare Organisation: Nottinghamshire Healthcare NHS Foundation Trust
Chief Investigator’s Organisation: University of Cambridge and Cambridgeshire and Peterborough NHS Foundation Trust
Chief Investigator: Prof Tamsin Ford
Start date: 11/07/2025

Suffering from depression or anxiety as a teenager is hard and can have a big impact on social and family relationships, and on education and employment. Teenagers who still have symptoms after usual or currently available treatment for depression or anxiety, or who relapse, need more treatment options. We have developed a new treatment, Mindfulness for Adolescents and Carers (MAC). MAC is a Mindfulness-based Cognitive-Therapy teaching young people skills to help them recognise and respond to early warning signs of depression or anxiety. We want to see if MAC can support 15–18-year-olds who have recurrent depression or anxiety to recover and stay well for longer. Depression or anxiety often runs in families, so we are asking parents/carers to take part as well, to see if taking part in MAC can be helpful for parents’/carer’s own mental health as well as supporting their child’s. MAC treatment sessions are group-based (either in-person or online), weekly for 8 weeks. We don’t know if MAC is better than the current treatments available. Therefore, to compare them, the young person will either be assigned to: Group 1: will take part in a MAC group, while continuing with their current treatment, OR Group 2: will continue with their current treatment and not take part in a MAC group. Parents/carers of those assigned to Group 1 are invited to attend sessions with other parents/carers, to work through similar materials. All young people and parents/carers will be asked to fill out some questionnaires online for 12 months, to measure any changes in how they think and feel. This will help us compare MAC’s effects to the current treatments available. We are recruiting from East of England, London, Devon, Sussex, Nottingham, Oxford. It is funded by the NIHR. To find out more please visit https://dev.psychiatry.cam.ac.uk/attend

Healthcare Organisation: South West London and St George’s Mental Health NHS Trust
Chief Investigator’s Organisation: South West London and St George’s Mental Health NHS Trust
Chief Investigator: Anita Jibero
Start date: 02/07/2025

The relationship between childhood trauma (CT) and clinical outcomes in psychotic disorders is understudied, and the findings are unclear. Existing research suggests a relationship between CT and poor treatment outcomes in psychosis; however, findings remain inconsistent due to methodological limitations such as small sample sizes, lack of longitudinal follow-up, and reliance on self-reported trauma histories.

The Clinical Record Interactive Search (CRIS) platform provides a valuable opportunity to conduct a large-scale retrospective study using anonymised electronic health records (EHRs) from NHS mental health services. This present study aims to examine the relationship between CT and clinical outcomes in psychosis.

Healthcare Organisation: Oxford Health NHS Foundation Trust
Chief Investigator’s Organisation: Newcastle University
Chief Investigator: Professor John-Paul Taylor
Start date: 21/05/2025

Dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD) are related and complex illnesses with a wide range of distressing symptoms. People with DLB/PDD have worse quality of life, more complex symptoms, higher care costs, and are more sensitive to medications than people with Alzheimer’s disease (AD). Acetylcholinesterase Inhibitor (AChEI) are commonly used medicines that can help people with DLB/PDD by improving day to day functioning and thinking abilities. Another drug which might help is Memantine. Memantine is a prescription drug used to treat moderate to severe confusion in Alzheimer’s disease and may help to improve memory, awareness, and the ability to perform daily functions. However, it is not clear if adding Memantine to AChEI is beneficial for people with DLB/PDD.

The aim of this trial is to find out if adding Memantine to AChEI improves overall health and functioning for people with DLB or PDD.

Healthcare Organisation: South West London and St George’s Mental Health NHS Trust
Chief Investigator’s Organisation: South West London and St George’s Mental Health NHS Trust
Chief Investigator: Dr Aileen O’Brien
Start date: 13/05/2025

To identify and understand the socio-economic and other demographic factors contributing to ethnic disparities in compulsory detention under the Mental Health Act.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Newcastle University
Chief Investigator: Paul Donaghy
Start date: 30/04/2025

We are recruiting people with very late-onset psychosis(VLOP) for a clinical biomarker study, the CAP study. We want to use CRIS to identify potential past and current VLOP cases, who can then be approached and offered the opportunity to participate in this study. (NB. We will only be recruiting individuals who have capacity to give informed consent for study participation.)

The CAP study will pilot the use of blood and brain imaging (MRI and DaTscan) assessment of neuroinflammatory and neurodegenerative features in VLOP, examining the tolerability of these tests, and the frequency of neurodegenerative disease/dementia-associated findings. People with VLOP frequently experience barriers to both clinical care and research, therefore CRIS records searching will be very useful in improving identification of people who may be eligible to take part.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator: Rob Dudley
Start date: 03/04/2025

One in three people with psychosis experience distressing visual hallucinations (VH) – seeing things that others cannot. When VH occur, they can have a detrimental impact on people’s lives, such as more frequent and prolonged hospital admissions, and greater likelihood of suicide.

A previous study by this team (The experience of VH in psychosis from the first-person perspective: IRAS ID: 291872) spoke to 12 people with VH. We found that the way in which people make sense of their VH are one of the keys factors driving distress. For example, when people thought VH were negative or threatening, they found them to be more distressing and this had a bigger impact on their lives. The next step is therefore to explore this on a larger scale to understand more about people’s appraisals of VH. Then this can be used to validate a scale of VH appraisals and develop targeted treatments for these.

To do so, this study will develop a questionnaire focused on people’s beliefs about VH. It will also explore the relationship of visions to other potential casual mechanisms such as poor sleep, and excessive worry.

900 people with psychosis will complete self-report questionnaires (approximately 60-80 minutes). After this, a subgroup of 100 participants will be asked to repeat some of the measures a week later to test if the appraisals measure is consistent.

We will recruit participants via the Research Delivery Networks (RDN) which has research staff based in NHS Trusts nationwide. The study is funded by the National Institute of Health Research. Recruiting via the RDN is a method which has been successfully used by other research group, with minimal risks identified.

By developing a new measure and our knowledge of causal mechanisms of visions, it will be the next important steps to developing better treatments for these.

t involves completing a questionnaire pack, which explores a range of experiences such as visions, sleep, worry, and mental imagery. It takes about an hour to complete. You can do this with support from research staff or independently online.

Healthcare Organisation: Oxford Health NHS Foundation Trust
Chief Investigator’s Organisation: Southern Health NHS Foundation Trust
Chief Investigator: Dr Peter Phiri
Start date: 31/03/2025

This project focuses on the prevalence and incidence of disordered eating behaviours within the UK population. Utilizing the Clinical Record Interactive Search (CRIS) platform, it will analyse de-identified data from the Oxford Health NHS Foundation Trust. Targeting individuals over the age of 11 who have exhibited disordered eating behaviours, this initiative seeks to provide a comprehensive view of the issue within the regional context. By identifying trends and patterns, the project aims to fill existing research gaps and enhance understanding of disordered eating’s impact. The project underscores a collaborative approach to tackling one of today’s most pressing health challenges.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Newcastle University
Chief Investigator: Oladayo Owoeye
Start date: 18/03/2025

Exploratory analysis
This access request aims to provide access to CNTW data for exploratory purposes. The project will allow analysts from NortHFutures to familiarise themselves with data on Maternal Mental Health Services (MMHS), Perinatal CMHT services and the Mother and Baby inpatient unit.
The proposed analysis described below will be carried out on linked data held in the NENC Secure Data Environment (SDE). Whilst the SDE is not operational yet, this project will allow exploratory analysis to inform this future study.

Permission to access CNTW data on the SDE will be sought through SDE specific governance arrangements and falls outside the scope of this request.

Background
Maternal mental health is a critical and often underserved area of mental health research. Postpartum depression, anxiety, child mental health, homelessness after childbirth and other perinatal/postnatal mental health challenges significantly impacts both mothers and their children, making it a vital focus within mental health recovery pathways.

The maternal mental health recovery pathway can help capture both short-term variations and long-term recovery trajectories, providing more accurate and personalised predictions. These could include daily mood ratings, sleep patterns, medication adherence, therapy session attendance, demographic information, social support service utilisation, life events, and other relevant factors. It will align clinical data by timestamp and define event-based windows such as pre-crisis, post-crisis periods.
Analysis proposal
The quantitative analysis/modelling will be vital in addressing of the maternal mental health recovery pathway in the context of predictive models i.e. interventions it can provide for early identification of at-risk individuals, tailor interventions to maternal-specific needs, inform policies and service delivery models that integrate clinical and community support systems.

The study will:
(i) Develop predictive models to identify maternal mental health risks and examine recovery pathways.
(ii) Evaluate the effectiveness of data-driven interventions in improving maternal mental health outcomes.
(iii) Address social, economic, psychological determinants of maternal mental health.
(iv) Leverage analysis to understand the progression of maternal mental health conditions over time.
Impact
By utilizing clinical datasets, the study will uncover insights into risk factors pre/post crisis, temporal trends, and effective interventions. The metrics, such as predictive accuracy, data integration quality, and intervention success rates which will drive early risk identification, personalised care, efficient resource allocation, and holistic recovery pathways.

Healthcare Organisation: Cornwall Partnership NHS Foundation Trust
Chief Investigator’s Organisation: Cornwall Partnership NHS Foundation Trust
Chief Investigator: Dr Murton
Start date: 17/03/2025

COMP006 (A Phase III, multicentre, randomised, double-blind, controlled study to investigate the efficacy, safety, and tolerability of two initial administrations of COMP360 in participants with treatment-resistant depression) Protocol: Version 4.0 – 15 November 2023.

Database search to identify potentially eligible patient cohort for pre-screening

Healthcare Organisation: Cornwall Partnership NHS Foundation Trust
Chief Investigator’s Organisation: Cornwall Partnership NHS Foundation Trust
Chief Investigator: Dr Kiran
Start date: 17/03/2025

Optimising cultural expeRIences for mental health in underrepresented younG people onlINe (ORIGIN) – Youth Voice

Healthcare Organisation: Oxford Health NHS Foundation Trust
Chief Investigator’s Organisation: Department of Psychiatry, University of Oxford
Chief Investigator: Dr Ivan Koychev
Start date: 07/01/2025

On rare occasions people with dementia need to be admitted to psychiatric inpatient units. These patients often have complex mental and physical health problems and might be near the end of their life. It is unclear how this complexity affects the outcomes of mental health admissions, as for example survival. Previous studies showed that dementia patients have an increased likelihood of death after admittance to psychiatric inpatient units, while we have little understanding of other factors that influence this relationship. In this study, we plan to run parallel analysis of data across several NHS Trusts in the UK to estimate the variability in mortality of dementia patients after their admittance to the psychiatric inpatient units.

Healthcare Organisation: Cornwall Partnership NHS Foundation Trust
Chief Investigator’s Organisation: Cornwall Partnership NHS Foundation Trust
Chief Investigator: Dr Shankar
Start date: 01/01/2025

This Epilepsy Research Database is focussed on building an ongoing evidence base evaluating the outcomes of Anti-Epileptic Drugs and epilepsy treatments for people with Intellectual Disability (ID) and/or Pervasive Developmental Disorders (PDD such as Autism). This involves collecting data for all people with epilepsy (Those with and without an ID and/or PDD). All patients currently or previously prescribed an Anti-Epileptic Drug (or epilepsy treatment) which is part of a live arm of the Research Database Register are therefore eligible to participate.

Efficacy (impact on seizures) tolerability (withdrawal) and other factors are compared for all patients who have an ID or PDD and those who do not have an ID and/or PDD. Where a medication or treatment is prescribed for a specific population/s of patients with ID and Epilepsy, data for this single cohort is analysed.

Five medication arms have been studied between 2015 and 2023 and we plan to continue to 2029 with additional medication arms.

Data Collection Arrangements
All data collected is retrospective and currently held in NHS electronic health Record systems. Data collected is focussed on demographics, clinical features, medication dose and side-effects, concurrent medications, seizure frequency, withdrawal within 12 months and quality of life. Data is inputted through Electronic Data Capture. Patients consent to the collection of these data.

Healthcare Organisation: Hampshire and Isle of Wight Healthcare NHS Foundation Trust
Chief Investigator’s Organisation: Hampshire and Isle of Wight Healthcare NHS Foundation Trust
Chief Investigator: Dr Christopher Lawrence
Start date: 02/12/2024

The use of Antipsychotic Polypharmacy (APP) and High Dose Antipsychotic Therapy (HDAT) in the treatment of schizophrenia, which is not recommended by either national or local guidance, continues to be a prevalent issue within psychiatric practice. This study aims to explore the factors which may be contributing to the prescribing of APP or HDAT and therefore identify potential strategies for improving antipsychotic prescribing practice within psychiatry.

Healthcare Organisation: Hampshire and Isle of Wight Healthcare NHS Foundation Trust
Chief Investigator’s Organisation: University of Southampton
Chief Investigator: Dr Thomas Richardson
Start date: 01/11/2024

This study aims to investigate the impact of deprivation on clinical variables in individuals with psychosis (including hospitalisation, not attending appointments, engagement with service, being offered and completing CBT, symptom severity, being discharged due to non-engagement, and substance use). The study will contribute to a better understanding of the socioeconomic determinants of mental health outcomes, which will consequently inform more targeted interventions for individuals living in poverty with psychosis.

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Gateshead Health NHS Foundation Trust
Chief Investigator: Allison Cowling
Start date: 24/10/2024

As a Masters’ Dissertation project linked with my Gateshead Public Health work, I’m hoping to gather more data and contribute to the evidence base around self-harm. While we have quite a lot of data around suicide locally, there is not a huge amount of data around self-harm. As self-harm prevention is a key part of suicide prevention, and those who have self-harmed are a priority group in the national strategy, it is important to understand who makes up this priority ground. The aim of this research is to explore data around self-harm presentations to hospital (via progress notes related to contact with psychiatric liaison teams). The data will be analysed to better understand the determinants and risk factors for self-harm. Potential factors I hope to analyse as age, gender, ethnicity, LSOA, IMD, methodology, comorbidities, multiple presentations, and trends over time.

Healthcare Organisation: Oxford Health NHS Foundation Trust
Chief Investigator’s Organisation: Department of Psychiatry, University of Oxford
Chief Investigator: Rachel Tsz Suet Chow
Start date: 07/10/2024

This project aims to predict patients’ likelihood of developing schizophrenia after experiencing substance-induced psychosis. I will extract electronic health record data to study the demographic, social, and clinical factors associated with a new diagnosis of schizophrenia or other permanent psychoses following substance-induced psychosis.

I will use these findings to develop and validate a web-based calculator that calculates the likelihood a person with substance-induced psychosis develops permanent psychoses at a specific time in the future. Two separate datasets will be used for development (South London and Maudsley NHS Foundation Trust) and validation (Oxford Health NHS Foundation Trust) respectively.

Healthcare Organisation: Oxford Health NHS Foundation Trust
Chief Investigator’s Organisation: Department of Psychiatry, University of Oxford
Chief Investigator: Dominic Oliver
Start date: 07/10/2024

Psychosis is a difficult mental health disorder to experience and it is preventable. Prevention of psychosis requires us to detect people at risk before they develop the disorder but currently the majority of people go undetected. To improve this, we developed a simple transdiagnostic risk calculator for psychosis using electronic health record data in South London. This model performs well in London and in Oxford and has shown to be feasible to be used in real-world clinical practice to improve care.

This risk calculator has since been improved by adding in 14 different symptom and substance use measures that can be automatically extracted from patient notes and letters. However, the performance of this new risk calculator has yet to be tested in Oxford Health, which we want to do in this study.

Healthcare Organisation: Nottinghamshire Healthcare NHS Foundation Trust
Chief Investigator’s Organisation: Compass Pathways Limited
Chief Investigator: Prof Allan Young
Start date: 07/10/2024

The COMP 006 study is trying to find out whether an investigational medicine, given with psychological support, can improve depressive symptoms for those who have treatment-resistant depression (TRD). The study will compare the efficacy, safety and tolerability of three different doses of the active investigational medicine alongside psychological support. All participants will receive one of three doses of COMP360 during the study. Some participants may be offered additional treatment sessions, depending on the results of their previous session. Everyone in the study will have to stop taking any medicines that are prohibited by the study rules, including antidepressants. The COMP 006 study lasts up to 62 weeks, made up of a screening period of 3-10 weeks and a treatment and follow-up period that includes three parts (Parts A, B and C). Part A includes two treatment sessions with COMP360 and a nine-week follow up period. During Part B, eligible participants will be re-treated with COMP360 and be followed for 17 weeks. During Part C, eligible participants will receive treatment with COMP360 and be followed for a further 26 weeks.

Healthcare Organisation: Cornwall Partnership NHS Foundation Trust
Chief Investigator’s Organisation: Cornwall Partnership NHS Foundation Trust
Chief Investigator: Dr Jacobsen
Start date: 11/09/2024

Allogeneic ABCB5-positive dermal mesenchymal stromal cells for treatment of CVU

Healthcare Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator’s Organisation: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Chief Investigator: David Cousins
Start date: 11/09/2024

The principal research question is whether the CR intervention provides significant and durable effects on psychosocial functioning over treatment as usual (TAU) for people with bipolar disorder.
The study is a multi-site, single-blind RCT comparing CR+TAU to TAU alone for euthymic bipolar patients.
Cognitive Remediation intervention (CIRCuiTS computerised program, Reeder & Wykes, 2010): Participants will receive 30-40 hours of CR over the course of 12-weeks. Face-to-face sessions (up to 1 hour long) will be held at least once per week, but participants will be encouraged to attend up to 3 sessions per week if feasible; an alternative arrangement of twice-weekly remote sessions will be offered, and all individuals will be provided unlimited access to use the program in their own time, should they wish to additionally practice independently. This intervention aims to tailor towards individual needs. Guided by previous studies, we will consider a minimum dose of 20 CR hours to be considered to have undertaken the intervention.
Participants in the intervention arm will also receive treatment as usual in addition to CR.

Healthcare Organisation: Hampshire and Isle of Wight Healthcare NHS Foundation Trust
Chief Investigator’s Organisation: Hampshire and Isle of Wight Healthcare NHS Foundation Trust
Chief Investigator: Dr Peter Phiri
Start date: 06/09/2024

This project focuses on the prevalence and incidence of disordered eating behaviours within the Wessex population. Utilizing the Clinical Record Interactive Search (CRIS) platform, it will analyse de-identified data from the Hampshire and Isle of Wight NHS Foundation Trust. Targeting individuals over the age of 11 who have exhibited disordered eating behaviours, this initiative seeks to provide a comprehensive view of the issue within the regional context. By identifying trends and patterns, the project aims to fill existing research gaps and enhance understanding of disordered eating’s impact. This foundational work is crucial for developing targeted, effective interventions tailored to the needs of the Wessex community. Engaging with key stakeholders and highlighting the likely impact projects like the Wessex Secure Data Environment, will have in the future. The project underscores a collaborative approach to tackling one of today’s most pressing health challenges.