Studies Recruiting at ELFT

Summary: A large trial testing a new, digitally-enabled group therapy programme for common mental health conditions such as anxiety and depression. The 12-session intervention combines digital tools with group psychotherapy and is designed to be flexible, addressing a range of mental health needs.

Inclusion / Exclusion Criteria:

Inclusion criteria

• Age ≥17
• Literate and fluent in the English language, which would enable group interactions and learning via online materials
• With access to an internet-connected device (e.g., computer, phone) and confidential space
• Referred to NHS-TT services
• Assessed by a qualified psychological professional and deemed to be eligible for high intensity CBT (this includes low risk of harm to self or others)
• Currently on waiting list for high intensity CBT and not accessing any other psychological interventions. This includes patients accessing pharmacotherapy but who are additionally seeking psychological treatment.
• Presenting symptoms of one or more internalizing disorders (major depressive disorder, generalised anxiety disorder, panic disorder, agoraphobia, specific phobias, somatoform disorder, obsessive-compulsive and related disorders, body dysmorphic disorder, post-traumatic stress and related disorders)

Exclusion criteria

• Age ≤ 16
• Not able to speak or read English fluently, which would require more individualised support with interpreters
• No access to internet-connected device or confidential space to engage with digital intervention
• Not involved with NHS-TT services
• Assessed by a qualified psychological professional and not deemed to be eligible for high intensity CBT on the basis of mental health condition and/or risk assessment (e.g., acute risk of suicide at the time of assessment)
• Already accessing a high intensity psychotherapy or other forms of psychological treatment (e.g., private therapy, counselling)
• Assessed as having a primary presenting problem of one of the following disorders at the time of initial assessment and/or currently receiving treatment from a specialist service for one of the following disorders: eating disorders, substance use disorders, psychotic disorders, and bipolar disorders.

ELFT Principal Investigator: Daniela Antoinette

To learn more, email: Tamar Sollman (Lead for UpLiftX)

Summary: Up to a quarter of women struggle with serious anxiety symptoms during pregnancy. Many women will not improve without treatment, with symptoms continuing postnatally and for some, leading to depression. High anxiety during pregnancy is related to negative outcomes in childbirth, baby development and difficulty in bonding with baby. Babies of mothers who struggle with anxiety during pregnancy can have more problems with their emotions, behaviours and cognitive development. There is a lack of high quality research about the best way to help mothers. In the NHS most mothers with antenatal anxiety (65%) are seen in primary mental health care (IAPT), but IAPT lacks treatments that specifically address antenatal anxiety.

In a feasibility study a 5-session group intervention (CALM) that gives pregnant women tools to manage anxiety, particularly worries about pregnancy are developed and tested. The CALM treatment includes partners or a close support and the group encourages peer support. This trial evaluates whether offering CALM together with usual treatment is more effective for pregnant women who have problems with anxiety, compared to usual treatment on its own. Over an 18-month-period, the aims to recruit 484 women to the trial from five sites, both urban and rural, that have people from different ethnic and income backgrounds. The research team works with community connectors to help engage pregnant women from diverse backgrounds. 

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• 18 years or older and can provide consent to the study
• Eligible to be seen in primary care NHS Talking Therapies for Anxiety and Depression (NHS TTad) services (formerly Improving Access to Psychological Therapies: IAPT
• Score above a clinical threshold on a widely used anxiety measure (GAD-7; 8 or more)    

Exclusion Criteria: 

• Women and birthing persons who are actively suicidal.
• Substance abuse.
• Diagnosis of psychosis or bipolar disorder
• Childbirth-related PTSD
• Current psychological treatment for anxiety at baseline interview.

ELFT Principal Investigator: Dr Sophie Gullick

To learn more, email: Sarah Boughetane (CSA for Acorn II)

Summary: A clinical trial testing whether clozapine can be used earlier in the treatment of psychosis. This randomised controlled trial focuses on young people with treatment-resistant psychosis and aims to understand how well clozapine works in real-world NHS settings.

Inclusion / Exclusion Criteria:

Inclusion Criteria
•    Age ≥12 and <25 years at baseline. 
•    Meets criteria for schizophrenia or related disorder, in the range ICD-10v2016 F20.x, F22.x-F29.x 
•    Meets NICE criteria for treatment resistance, defined as: 

• a. Previous trials of at least two different antipsychotic drugs with adequate adherence (estimated <20% missed doses) – both treatment trials to exceed 4 weeks at adequate doses (within the dose range given in the British National Formulary and the British National Formulary for children).
• b. At least 1 of these trials must be with a second-generation drug.

•    Positive and Negative Syndrome Scale (PANSS) total ≥70, at least 2 items >4 
•    Clinician Rating Scale [24] (CRS) ≥3. 
•    Capacity to give informed consent OR has a legal representative able to give consent to the study.

Exclusion Criteria: 
•    Psychosis predominantly caused by substance misuse. 
•    Pregnancy. 
•    Breastfeeding. 
•    Women of child-bearing potential (WOCBP*) not using at least acceptable methods of contraception** during the study 
•    Previous adequate trial of clozapine. 
•    CNS disorders (ICD-10 G00-26; G40-41, G45-46; G80-94, G97). 
•    Concurrent medications with documented interactions with antipsychotics. 
•    Participation in a clinical trial involving any unlicensed investigational medical product within the last 3 months. 
•    Positive test for COVID-19 within the past 10 days. 
•    Current Electroconvulsive Therapy (ECT) 
•    For participation in the substudy MRI scan only, standard contraindications to MRI at 3 Tesla such as ferromagnetic or electronic implants.

* WOCBP defined as: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. 

** acceptable methods of contraception include: 
•    progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action 
•    male or female condom with or without spermicide *** 
•    cap, diaphragm or sponge with spermicide ***

*** A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable, but not highly effective, birth control methods 23

Acceptable methods are the minimum requirement. It should be noted that the requirement for ‘at least acceptable methods of contraception’ would include the above methods but also include all ‘highly effective’ methods listed below: 

•    combined (estrogen and progestogen containing) hormonal 
•    contraception associated with inhibition of ovulation 1: oral 
•    intravaginal 
•    transdermal 
•    progestogen-only hormonal contraception associated with inhibition of ovulation 1: oral 
•    injectable 
•    implantable 
•    intrauterine device (IUD) 
•    intrauterine hormone-releasing system ( IUS) 
•    bilateral tubal occlusion 
•    vasectomised partner 
•    sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments). 

ELFT Principal Investigator: Dr Alex Sales

To learn more, email: Ben Wong (Research Assistant for CLEAR)

Summary: The NIDUS (New Interventions for Independence in Dementia Studies) programme, now renamed GRACE (Goal diRected, Accessible & Evidence-based Care) supported people living with dementia and family carers to set goals around their individual priorities and needs for living as well as possible at home. They met with a therapist 6-8 times over 6 months, for an hour each time, to receive support sessions (from a manual which we developed) tailored to their personal goals. Then, in the next six months they received 2-4 further support phone calls. We found that this support helped families achieve their goals.

This research aims to find how well this new way of providing support linked to personal goals works in health and social care community services in England, and how it can be used to make a positive difference to many people living with dementia and their families. People with dementia and the person who provides them care are being invited to receive the GRACE support via your local service.  

Inclusion / Exclusion Criteria:

Inclusion criteria

• To be added

Exclusion criteria

• To be added

ELFT Principal Investigator: Claudia Cooper

To learn more, email: Zainab Dedat (Lead for Instilled)

Summary: About 18% of people with learning disability (also known as intellectual disability or ID) have behavioural problems such as being aggressive towards other people. Reasons include mental health problems and having a poor quality of life such as not having meaningful activities or friends. Behavioural problems can lead to the person being excluded from day services and having to leave their home if family and paid carers cannot cope with the behaviour. They may also be admitted to psychiatric hospital. There are psychological approaches that try to understand the cause of behaviour but only improve behaviour for short periods and do not appear to improve quality of life. One existing approach called DIALOG+, delivered by health professionals and supported by an app, does improve quality of life in people with mental health problems, but it has not been used in people with ID. The research team want to make DIALOG+ accessible and suitable for people with ID and to test if it improves quality of life and reduces behavioural problems.

The research team will develop an adapted co-produced version of DIALOG+ (aDIALOG+) and will do some initial testing with 5 clinicians from community ID teams and 5 care workers who will deliver aDIALOG+ to service users. The team will then carry out a feasibility study of aDIALOG+ to see if it can be used by clinicians in community ID services and care workers in care homes. The team will see if they can recruit enough clinicians (12), care workers (about 30-50 from 10 care homes) and service users (30 from community teams and about 40 from care homes) to take part, and look at how often aDIALOG+ is delivered. The team will interview service users, clinicians and care workers to find out what they liked and did not like about aDIALOG+ and what could be improved.

Inclusion/Exclusion Criteria

Inclusion criteria:

Service Users Inclusion Criteria

• Aged 18 or over
• Mild or moderate ID based on service records / clinical notes
• Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical aggression or damage to property in the last 3 months)
• Living in any setting including the family home and supported living/ residential home
• Can provide informed verbal or written consent

Clinicians Inclusion Criteria

• Aged 18 or over
• Currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID
• From any profession (e.g. psychology, nursing, speech and language therapy, psychiatry, social work), grade 4 and above with a minimum of six months experience working with people with ID
• Consent to participation

Care Workers Inclusion Criteria

• Aged 18 or over
• Have worked in the care home for at least three months
• Provide at least one day of support per week to service users
• Consent to participation

Exclusion criteria:

Service Users Exclusion Criteria

• Under 18 years of age
• Severe ID based on service records / clinical notes
• Likely to move out of borough within the next three months or at imminent risk of hospital admission
• Unable to provide informed verbal or written consent

Clinicians Exclusion Criteria

• Under 18 years of age
• Not currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID
• Below grade 4 and less than six months experience working with people with ID
• Do not consent to participation

Care Workers Exclusion Criteria

• Under 18 years of age
• Have worked in the care home for less than three months
• Do not provide at least one day of support per week to service users
• Do not consent to participation

ELFT Principal Investigator: Dr Afia Ali

To learn more, email: Anna Myerscough (Lead CSO for ICONIC)

Summary: Do you support carers of people with psychosis? The Osmosis project wants to hear form you. This project aims to learn about carers' experiences of support in order to inform the development of resources and actions to support carers. The project will involve a 90 minute focus group with other people who provide support to psychosis carers held online via Microsoft Teams You will receive a £20 voucher if you are participating in your own time Your information will be kept private and you will not be identified in any outputs.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• You are employed or volunteer in a role where you provice support to carers of people with psychosis
• Are aged 18 or older
• Work or volunteer in Hackney, Tower Hamlets, or East Sussex

ELFT Principal Investigator: Mary Brazier   

To learn more, contact: Email elft.researchoffice@nhs.net (Lead CSA TBC for OSMOSIS) 

Summary: Blood tests are a promising way to improve the diagnosis of dementia. But the research so far had participants who do not reflect real-world patient populations (for example in terms of their ethnicity or having other common illnesses). 

This study aims to assess the usefulness of blood-based tests for dementia. The READ-OUT Observational Study investigates blood tests in people seen in memory clinics across the United Kingdom, for a wide variety of dementias and other memory problems, including people who do not have a disease such as Alzheimer’s as the cause of symptoms. It will focus a lot of its recruitment from people from backgrounds that are not often involved in research: for example, those who are very elderly, from UK ethnic minorities, those in deprived areas or with multiple illnesses, etc. 

Inclusion/Exclusion Criteria: 

The participant may enter the study if ALL of the following apply:

• Willing and able to give informed consent for participation in the study (translation needs for study information and forms for non-English speakers will be defined locally) OR Adults who otherwise lack the capacity to consent but for whom advice regarding participation has been obtained via a consultee using the personal or nominated consultee process
• Male or Female, aged 45 years and above
• Referred or referable with cognitive or behavioural symptoms and/or diagnosed with a cognition related disorder; including those with subjective cognitive impairment and functional disorders. 

The participant may not enter the study if ANY of the following apply:

• Lack of venous access
• Unwilling to consent to NHS data linkage or in Northern Ireland, unwilling to allow long term follow up by access to electronic NHS records. 

ELFT Principal Investigator: Dr Nick Bass

To learn more, email: Zainab Dedat (Lead CSO for READ-OUT)

Summary: Care (Education) and Treatment Reviews (C(E)TRs) were introduced in 2015 and are intended to help reduce reliance on in-patient care and ensure that people get the right support in the community.

We are doing research to understand if C(E)TRs improve the care and support that people with a learning disability and/or autistic people receive in the community.    

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

Participants:

• Children/adolescents (aged between 14 and 17 years, inclusive) or adults (≥18 years) with a clinical diagnosis of learning disability (of any degree) or autism (diagnosis based on service records, expected to conform to ICD-10 chapter F7- criteria for learning disability or ICD-10 F84 criteria for autism)
• Under the care of a community mental health service (e.g. CAMHS, CLDT, CMHT)
• Rated as red or amber on the Dynamic Support Register
• Provide informed consent to taking part or, where an adult lacks capacity to consent to participate, a personal or nominated consultee has signed a declaration form or, in the case of children/adolescents (<18 years), a parent/guardian has signed a consent form

Carers:

• Family or paid carer of a participant enrolled into the study
• Age ≥16 years
• Provide informed consent to take part in study

Exclusion Criteria: 

Participants:

• Children <14 years of age
• No clinically-confirmed diagnosis of learning disability or autism
• Not on the Dynamic Support Register
• Currently admitted to a psychiatric hospital
• Does not provide informed consent or, where an adult lacks capacity, there is no consultee declaration or, in the case of children/adolescents (<18 years) a parent/guardian has not signed a consent form

Carers:

• Age <16 years
• Does not provide informed consent to take part in study

ELFT Principal Investigator: Dr Afia Ali

To learn more, email: Anna Myerscough (Lead CSO for OPTICAT)

Summary: People living with severe mental illness can sometimes feel very lonely and may not have friends, family, or community around them for support. These friends, families and communities are what we call social networks. This study aims to understand more about how factors like being around these social networks might lead to meaningful improvements for people with severe mental illness. This study will also examine how social factors can affect key biological responses such as stress and inflammation, measured through blood and saliva samples, that may worsen outcomes of mental illness. Findings from this study will be used to develop and test approaches that focus on social factors, such as connecting people to community activities, groups and clubs to improve health and wellbeing.  

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Aged 18-95
• Diagnosis of MDD, bipolar disorder (F30-F39), or psychosis-related disorders (F20-F29) (ICD-10 criteria), confirmed through electronic medical records or clinician opinion
• Capacity to provide informed consent and undertake study procedures
• English language proficiency to the level of conducting health consultations
• Living in England 

For the EMA component of the study

• Capacity to use devices (smart phones) required for data collection 

Exclusion Criteria: 

• Prisoners or in custody of HM Prison services
• Inability to complete study measures as assessed by the study team
• Deemed by clinical team and/or clinical members of the research team to be too unwell to complete study procedures

ELFT Principal Investigator: Dr Rahul Bhattacharya

To learn more, email: Nargis Rahmanfard (Lead CSO for Social Cohort)

Summary: This project looks at how mental capacity is assessed when urgent clinical decisions are needed. By observing current practice, the study aims to improve the way professionals assess decision-making capacity in fast-paced healthcare situations.

Inclusion / Exclusion Criteria: 

HELPS will focus on three service users’ groups: people with mental health problems, physical health problems or learning disabilities, and interview family members/friends (carers) of service users.

Any service users (and supporting carers) who are observed receiving a mental capacity assessment during fieldwork or have received a capacity assessment in the last three months will be invited for interview.

Inclusion: Three sampling criteria:

1) being representative of organisational barriers and best practices as identified previously in work package 1;

2) geographic location, i.e. North of England, Midlands, South of England, Wales;

3) areas with different ethnic diversity, to identify variation in experience of working with people from different ethnic groups as well as a proxy variable for urbanicity and social deprivation.

Exclusion: Being a professional, a service user or a service user’s carer without any experience in MC assessment under the Mental Capacity Act.

ELFT Principal Investigator: Rikke Albert

To learn more, email: Nargis Rahmanfard (Lead CSO for HELPPS)

Summary:  The aim of the PPiP2 study is to assess large number of people suffering from psychosis and identify those with anti-neuronal membrane antibodies in their serum which might be causing their illness. Participants with anti-neuronal membrane antibodies will be invited to take part in the SINAPPS2 trial. The immune system normally controls our ability to fight infection. If the immune system goes wrong it may attack our own body, causing diseases called ‘autoimmune’ diseases. It has been discovered that some of these autoimmune diseases can affect the brain, and in the early stages of the disease they can manifest through symptoms of psychosis.

We can diagnose some of these autoimmune diseases using blood tests to detect specific antibodies.  We are specifically interested in antibodies that may be the cause of symptoms of psychosis and possibly in some cases of schizophrenia. 

Inclusion/Exclusion Criteria:

Inclusion criteria:

• Age 16-60  
• Acute psychotic symptom(s) lasting more than 2 weeks but no longer than 2 years in current episode (first episode of psychosis or relapse after at least 6 month of remission)

Exclusion criteria:  

• Any neurological disorder
• Pregnancy 

ELFT Principal Investigator: Flavia Napoletano

To learn more, contact: Email Nargis Rahmanfard (Lead CSO for PPIP2)

Summary: East London Genes and Health is supporting studies looking at how genes influence disease. By involving large numbers of local Bangladeshi and Pakistani people the study hopes to find new ways of improving the health of Bangladeshi and Pakistani communities in East London and worldwide. The participants will be asked to donate a small saliva sample and share their GP and hospital medical records in strict with confidence with the study team.  

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• People living within reach of East London, or (second site) Bradford.
• Self described ethnicity: Bangladeshi, British-Bangladeshi, Pakistani, British-Pakistani
• Age 16 or over (no upper limit)
• Willingness to give a saliva DNA sample for analysis
• Willingness to grant investigators access to medical records (GP, Hospital, and national NHS) for the full duration (stage 1 and stage 2) of the study.
• Willingness to receive invitations for recall (stage 2 research activity) for the duration of the study (actual participation in all stage 2 research activity would be after a second informed consent process).

 Exclusion Criteria: 

• There will be no exclusion on the basis of gender, or disease status.
• Patients with mental and learning disabilities are included provided they are deemed competent to consent. However, patients with significant cognitive impairment will be excluded from the study as they may have reduced capacity to both comprehend the research and to agree to participate in it.  

ELFT Principal Investigator: Dr Nick Bass

To learn more, email: Anna Myerscough (Lead CSO for Genes & Health)

Summary: The aim of EDGI is to investigate genetic and environmental risk factors in individuals who may suffer, have suffered from, or have been diagnosed with an Eating Disorder, alongside facilitating recruitment of volunteers with Eating Disorders into the NIHR BioResource – Research Tissue Bank (NBR-RTB).   

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Participants who are aged 16 or over.
• Participants who have a lifetime occurrence of anorexia nervosa, bulimia nervosa, binge-eating disorder, or any other eating disorder defined in DSM-5.
• Participants who have been diagnosed and/or treated for anorexia nervosa, bulimia nervosa or binge-eating disorder or any other eating disorder defined in DSM-5.
• Participants with a probable and undiagnosed eating disorder identified through a screening questionnaire.
• Participants who have not stated their refusal to take part in future research.
• Participants who are willing to donate a biological sample for genetic analysis.
• Participants who are currently living or have permanent residence in England  

ELFT Principal Investigator: Dr Erica Cini

To learn more, contact: Email Nargis Rahmanfard (Lead CSO for EDGI)

Summary: The GLAD Study is exploring genetic risk factors in individuals who have suffered with or been diagnosed with depression and/or anxiety. The GLAD Study is currently the largest study focussing on Anxiety/depression and is a way for those who have experienced the conditions to join the NIHR Mental Health BioResource. The NIHR BioResource is a national initiative where the aim is to collect genetic and clinical data from volunteers to build up a central library of information about people’s health. The project will explore genetic and environmental risk factors associated with depression and anxiety disorders in the UK, to better understand these common disorders and help develop better treatments.   

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Participants who meet screening criteria for depression and anxiety and/or treated for depression or anxiety. 
• Participants who are aged 16 or over. 
• Participants who consent to be contacted about future recall studies based on their genotype and phenotype. 
• Participants who are currently living or have permanent residence in England, Scotland, Northern Ireland, or Wales

ELFT Principal Investigator: Professor Frank Rohricht  

To learn more, contact: Email Anna Myerscough (Lead CSO for GLAD)