Studies Recruiting at ELFT

Summary: ADHD is a common psychiatric disorder with a prevalence among adults of 2.5% and emerging research has shown some evidence of substantial comorbidity and shared genetics between adult ADHD and cardiometabolic diseases, such as obesity, type-2 diabetes and cardiovascular disease. However, not much research has been done on screening, diagnosis and clinical management of adults with ADHD and co-occurring cardiometabolic disease. The main aim of ART-CARMA is to collect real-world data from the patient’s daily life on the extent to which ADHD medication treatment and physical activity may influence cardiometabolic risks in adults with ADHD.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Diagnosis of DSM-5 ADHD 
• Aged 18-60 
• Able to give informed consent for participation 
• Fluent in English 
• Willing and able to complete self-reported assessments via smartphone 
• Willing to use either their own Android phone or a study Android phone as their only smartphone during the data collection period 
• Willing to wear the wearable device (EmbracePlus) during the data collection period Not on ADHD medication at the time of recruitment 

Exclusion Criteria: 

• Psychosis, currently experiencing a major depressive episode, mania, drug dependence over the last six months or a major neurological disorder 
• Recent contact with psychiatric acute care (admission, crisis team or liaison team (A&E)) in the last six months 
• Any other major medical disease which might impact upon the patient’s ability to participate in normal daily activities (e.g., due to hospitalisations) 
• Pregnancy 
• IQ < 70 
• Does not start ADHD medication following ADHD diagnosis (either due to personal choice or psychiatrist deciding not to prescribe ADHD medication)  

ELFT Local Lead: Dr Rahul Bhattacharya 

To learn more, contact: Email Anna Myerscough (Lead CSO for ART-CARMA)

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 Local Lead: Dr Erica Cini

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

Summary: The GLAD Study is a project set up to explore genetic risk factors in individuals who have suffered with or been diagnosed with depression and/or anxiety. The GLAD Study is a way for those who have experienced depression and/or anxiety 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 factors associated with risk for depression and anxiety disorders in the UK, to 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 Local Lead: Professor Frank Rohricht  

To learn more, contact: Email Zainab Dedat (Lead CSO for GLAD) 

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 people 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 Local Lead: Dr Nick Bass

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

Summary: The aim of this randomised control trial is to evaluate the clinical- and cost-effectiveness of a brief and low cost psychological intervention in reducing self-harm attendances to the emergency departments and improving secondary outcomes, i.e., self-reported self-harm, suicidality, psychological wellbeing, social outcomes, quality of life, experiences of attending the emergency department and suicide. 

Inclusion/Exclusion Criteria: 

Inclusion Criteria:

•  ≥16 years of age 
• Presenting to the ED 
• Presenting with self-harm, i.e., an intentional act of self-poisoning or self-injury, irrespective of the motivation or apparent purpose of the act and/or presenting with suicidal ideation, i.e., thoughts of not wanting to live 
• On presenting to the ED with self-harm and/or suicidal ideation, can be admitted for a brief admission to the acute hospital or a brief crisis admission 
• Provide informed consent to take part 

Exclusion Criteria: 

• A current or previous participant of the Assured study 
• Patients admitted to a psychiatric hospital 
• Patients with cognitive (e.g. dementia) or other psychiatric difficulties interfering with ability to participate 
• Experiencing a psychotic episode 
• No capacity to provide written informed consent 
• Needing an interpreter 
• Ministry of Justice patients subject to a restriction order 
• Patients receiving intensive psychological input that explicitly precludes them from engaging in other psychological interventions/psychological treatment e.g. DBT 
• Concerns about safety to practitioner or researcher 
• Not being registered with a GP Living out of Trust*  

ELFT Local Lead: Rikke Albert/Chloe Beale

To learn more, contact: Email Isabel Graham (Lead CSO for ASSURED)

Summary: People with Schizophrenia and other similar mental health conditions, such as recurrent psychotic disorders are often given Antipsychotic medication. Although Antipsychotics have been shown to reduce symptoms of Schizophrenia in the short-term, there is not much research on the long-term use and effectiveness of Antipsychotics. The original RADAR study examined the effects of reducing and discontinuing Antipsychotics in a flexible and supported manner compared to maintaining them in people with Schizophrenia or recurrent psychotic disorders. The RADAR follow-up study aims to follow-up people enrolled in the original RADAR study and explore the long-term effects of reducing and stopping Antipsychotics.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Aged over 18 years 
• A clinical and/or ICD10 diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or other non-affective psychosis 
• More than one previous episode of relapse or psychotic exacerbation, or a single episode lasting more than one year 
• Taking antipsychotic medication 

Exclusion Criteria: 

• Participant lacks capacity to consent to the trial. 
• Participant has insufficient command of spoken English to understand trial procedures 
• Participant subject to section 37/41 of the Mental Health Act (MHA) or a Community Treatment Order (CTO) that includes a requirement to take antipsychotic medication 
• Clinician considers there will be a serious risk of harm to self or others 
• Participant has been admitted to hospital or had treatment from the Home Treatment or Crisis Team within the last month 
• Females who have a confirmed pregnancy 
• Females who are breast-feeding Involvement in another IMP trial 
• No contraindications to continuing on antipsychotic medication  

ELFT Local Lead: Dr Dave Baillie

To learn more, contact: Email Refah Ahmed (Lead CSO for RADAR Follow-up Study) 

Summary: RECOLLECT 2 is a work package of three research studies investigating the effectiveness and key characteristics of Recovery Colleges which are a new innovative approach to supporting people living with mental health problems. The overall study aims to address how Recovery Colleges work and can be beneficial to people who use mental health services alongside developing the evidence base for Recovery Colleges in England.

Inclusion/Exclusion Criteria:

Varies depending on the 3 different research studies, but Inclusion Criteria for Recovery Colleges participating in all 3 studies are: 

• A focus on supporting personal recovery 
• An aspiration to use co-production, defined as individuals with lived experience working with staff or subject experts to design and deliver all aspects of the Recovery College 
• An aspiration to use adult learning approaches, in which students and trainers collaborate and learn from each other by sharing experiences, knowledge, and skills 
• Location in England 
• Agree to participate  

ELFT Local Lead: Tony Isles 

To learn more, contact: Email Zainab Dedat (Lead CSO for RECOLLECT 2)

Summary: This randomised controlled trial aims to identify which brief, remote psychosocial intervention for people with SMHPs who report recent suicidal ideation or suicide attempt is most clinically effective and cost-effective in preventing avoidable admissions in comparison to treatment as usual. Furthermore, it aims to determine the safety of the interventions. The brief remote interventions compared include structured peer support and safety planning. 

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Currently receiving care from a Home-Based Treatment Team/ Crisis team or have done so within the last 14 days, since referrals to HBTT/Crisis team are associated with increased risk of a psychiatric hospital admission in the near future. 
• Aged 16+ 
• Meet criteria for a diagnosis of SMHP (schizophrenia spectrum, bipolar, major depressive disorder, EUPD, PTSD or cPTSD) since these diagnoses account for the majority of PHAs for mental health difficulties 
• Experienced suicidal ideation or attempt within the last month / current crisis episode, as operationalised by answering ‘yes’ to items 1 or 2 of the Columbia-Suicide Severity Rating Scale. 
• Able to provide informed consent. 
• Receiving care from a Community Mental Health Team or Early Intervention Service, to ensure ongoing specialist mental health support following discharge from HBTT. 

Exclusion Criteria: 

• Organic impairment, as this could be the cause of mental health symptoms rather than a SMHP. 
• Non-English speaking, since two of the interventions are remotely delivered talking therapies and one of the interventions is a smartphone app which has only been developed in English. Provision for non-English speakers would be impossible on both financial and logistical grounds. 
• Primary diagnosis of a drug or alcohol dependence, as this could be the cause of mental health symptoms rather than a SMHP. 
• Moderate to severe learning disability as confirmed by the participants responsible clinician in their care team 
• Immediate risk to others, for ethical and safety reasons 
• Currently receiving psychiatric inpatient care (since people in recent contact with crisis teams may have already been admitted to hospital)  

ELFT Local Lead: Dr Justyana Sierpatowska

To learn more, contact: Email Jorge Castro Caicedo or Bibi Berrington (RAs on RAPID)

Summary: In the past people who have a learning disability were often excluded from taking part in research. This means that knowing what works well for them is not always clear. Lots of psychotherapies available to help people with mental health difficulties are based on talking, which might not always be the best approach for people with learning disabilities/difficulties. Doing artwork or creative things within art psychotherapy can be a helpful way for people to communicate about themselves. Interpersonal art psychotherapy has been designed to help people with learning disabilities in secure care. The art psychotherapist encourages people to use creative ways to express the things they would like to feel better about. 

We want to find out if interpersonal art psychotherapy is helpful and value for money for people with learning difficulties who are in secure care. We will be testing if interpersonal art psychotherapy works better than the standard care that is being provided. To do this we will need to recruit 200 people and put them into groups by chance, with half having interpersonal art psychotherapy and half on a waiting list for it. This is called a randomised controlled trial (RCT). Everyone in the study will get a chance to have interpersonal art psychotherapy.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• An inpatient in an NHS secure hospital/unit/service with the presence of learning disability/borderline intellectual functioning indicated by either (a) meeting validated assessment criteria (recognised cognitive testing and adapting functioning assessment), or (b) a score of 57 or below on the Learning Disability Screening Questionnaire (LDSQ). 
• Age 18 to 60 years. 
• Able to give informed consent. 
• A HONOS (Health of the Nation Outcome Scale) score between 1 and 4 for item 1 (Overactive, aggressive, disruptive, or agitated behaviour / Behavioural problems directed at others). 
• The participants' involvement in the study is supported by their responsible clinician and/or multidisciplinary team (MDT). 

Exclusion Criteria: 

• Unable to give informed consent.
• Learning disability/borderline intellectual functioning not indicated based on a validated assessment or screening questionnaire (i.e., not meeting validated assessment criteria or a LDSQ Score >57). 
• A HONOS score of 0 for item 1. 
• Planned discharge within 12 months of the start of the study. 
• Unstable/unmanaged psychotic symptoms requiring active assessment or treatment including medication dose titration (i.e., dose adjustment in the previous 4 weeks or with potential further dose adjustment planned for the following 4 weeks).  

ELFT Local Lead: Dr Lorna Downing

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

Summary: Suicide is the second-leading cause of death in young people globally according to the WHO (2014), and the strongest predictor of suicide is self-harm. Despite many young people presenting to emergency departments with self-harm, many of them have repeat attendances with very low rates of adolescents attending follow-up appointments. The aim of SASH, a randomised controlled trial, is to evaluate the clinical- and cost-effectiveness of a new brief psychological intervention in reducing repeat self-harm compared to treatment as usual in adolescents with self-harm who present to emergency departments.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• 12-19 years old 
• Presenting in crisis to the ED with self-harm or suicidal ideation with recent self-harm (within one month) 

Exclusion Criteria: 

• Possible Learning Disability, judged by clinician 
• Need for intensive treatment (i.e. more intensive treatment than the intervention offers e.g. 
• Tier 3.5 or an inpatient psychiatric admission) 
• Current psychotic episode 
• Registered with a GP outside of the MH trust catchment area  

ELFT Local Lead: Dr Ruth Woolhouse 

To learn more, contact: Email Zainab Dedat (Lead CSO for SASH)

Summary: UAA is part of a larger programme of research, aiming to develop a new psychological treatment to reduce aggression by forensic patients with psychosis. As part of the larger programme, UAA aims to understand what psychological factors “drive” aggression in patients and the questionnaire study aims to develop and validate a new measure assessing beliefs that support violence and to test, in a clinical sample, the associations and likely causal relationships between aggression and a number of psychological factors that may be important in the maintenance of aggression.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Participant is willing and able to give informed consent for participation in the study 
• Identifies as male, aged 16 years or above/ Diagnosed with non-affective psychosis (i.e. schizophrenia, schizoaffective disorder, delusional disorder, psychosis not otherwise specified) and/or affective psychosis (i.e. bipolar disorder). Using adult secondary mental health services, including forensic services (inpatient or community) 

Exclusion Criteria: 

• Insufficient English language to understand and complete questionnaires. 
• Identifies as female. 
• Primary diagnosis of alcohol or drug disorder, personality disorder, or organic syndrome. 
• Primarily sexual offending.  

ELFT Local Lead: Dr Marc Lyall

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

Summary: Around 50,000 people are discharged from acute mental health settings annually, and the transition period following discharge is high risk in terms of relapse, readmission and suicide. This study aims to understand the requirements of service users being discharged from adult mental health wards. It also aims to understand how service users, carers and staff understand personalised discharge planning and what they identify as key outcomes to determine this. MINDS aims to co-produce and evaluate an intervention to improve discharge from acute mental health wards.

Inclusion/Exclusion Criteria: 

For interviews/focus groups: All service users (18 years and over), under the care of the Mental Health Trusts involved, with capacity to give informed consent, admitted within the previous 12 months to study wards will be eligible for inclusion in the study. Participants for interviews and focus groups will be in the community, under a community mental health team, at time of participation. 

For Ward based observations: All service users (18 years and over) currently admitted on one of the selected wards, with capacity to give verbal informed consent.

Staff: 

All staff who have roles that impact on inpatient discharge (both directly and indirectly including management), working in one of the three Mental Health Trust sites, at service user, administrative and management levels will be eligible. 

Carers/supporters: 

All carers/supporters of people who have experienced inpatient discharge in one of the participating Mental Health Trusts will be eligible  

ELFT Local Lead: Dr Frank Rohricht

To learn more, contact: Email Emma Grindrod (RA for MINDS)

Summary: The SCEPTRE research programme was designed to develop and test the effectiveness and cost-effectiveness of a complex intervention aimed at promoting or maintaining smoking-related behaviour change. The overall aim of the study is to determine the feasibility and acceptability of delivering the multi-component SCEPTRE intervention in mental health services. The SCEPTRE intervention is 12-weeks and consists of components aimed at promoting or maintaining smoking-related behaviour change among patients following discharge from a smoke-free mental health inpatient setting.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Adults (18 years+) who smoked prior to/during admission on acute NHS mental health wards and express and interest in maintaining abstinence or positively changing their smoking behaviour following discharge 
• Planned discharge within 7-14 days to address/accommodation within Trust’s catchment area 
• Able to understand and communicate in English 
• Access to a telephone or alternative digital advice to receive post-discharge support 
• Willing and able to provide informed consent 

Exclusion Criteria: 

• Admitted under the care of older adult, learning disability, psychiatric intensive-care unit or forensic mental health services 
• Patients deemed not clinically appropriate to participate (at clinician discretion)  

ELFT Local Lead: Ogechi Anokwuru

To learn more, contact: Email Isabel Graham (Lead CSO for SPECTRE)

Summary: CONTACT-GAD aims to evaluate the clinical and cost-effectiveness of a psychological intervention for treatment resistant Generalised Anxiety Disorder (TR-GAD) in older people within a randomised controlled trial. Generalised Anxiety Disorder is the most common anxiety disorder in older people, with an estimated prevalence of up to 11%. Although Acceptance and Commitment Therapy is not part of the current care pathway in the UK for older people in TR-GAD, it may be particularly suited to older people with TR-GAD. The study will determine the effectiveness of tailored Acceptance and Commitment Therapy plus usual care in comparison to usual care alone for reducing anxiety in older people with TR-GAD.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Aged ≥60 years; 
• Diagnosis of GAD using the Mini-International Neuropsychiatric Interview 
• GAD that is ‘treatment resistant’, defined as GAD that has failed to respond adequately to pharmacotherapy and/or psychotherapy treatment, as described in step 3 of the UK's stepped care model for GAD 
• Living in the community (i.e. those living in domestic residences or assisted living facilities, but not care homes). 

Exclusion Criteria: 

• Judged to lack capacity to provide fully informed written consent to participate in the trial 
• A diagnosis of dementia or intellectual disability using standard diagnostic guidelines, or clinically judged to have moderate or severe cognitive impairment (e.g. due to probable dementia, traumatic brain injury, stroke, etc) 
• A diagnosis of an imminently life-limiting illness where they would not be expected to survive for the duration of the study 
• Expressing suicidal ideation with active suicidal behaviours/plans and active intent, as assessed using the Columbia-Suicide Severity Rating Scale Screener (40), for whom an inpatient admission would be more appropriate 
• Currently receiving a course of formal psychological therapy delivered by a formally trained psychologist or psychotherapist (e.g. CBT, psychodynamic psychotherapy, systemic therapy, counselling, etc), or those who are unwilling to refrain from engaging in such formal psychological therapy should they be randomly allocated to the ACT arm 
• Self-report having received ACT in the FACTOID feasibility study 
• Having already been randomised in the CONTACT-GAD trial or living with another person who has already been randomised in the CONTACT-GAD trial 
• Taking part in clinical trials of other interventions for GAD  

ELFT Local Lead: Dr Michelle Hamill

To learn more, contact: Email Refah Ahmed (Lead CSO for CONTACT-GAD)

Summary: Previous research has shown experiences of carers of patients treated under the Mental Health Act has showed that many carers feel isolated and unsupported, which can in turn lead to emotional difficulties and strained relationships with families and friends. The recent Mental Health Act Review recognised the need to support carers, but there are no routinely available services doing this. The OPAL project aims to explore what the expected barriers and facilitators are for one-to-one carer peer support in England and what a training package, which is adapted for provision in English NHS include. The study will use both qualitative interviews with a range of stakeholders such as carers, service users and NHS professionals as well as adapting an intervention for carer peer support originally developed in Germany called German EX-IN, for provision in England.

Inclusion/Exclusion Criteria: 

Inclusion Criteria for carers: 

• Carer for someone treated under the Mental Health Act within the last 10 years 
• Over 18 years old 
• Able to provide informed consent 
• Purposive sampling – similar number of participants; based on gender, ethnic groups and relationship to parents

ELFT Local Lead: Dr Kurt Buhagiar 

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

Summary: There are lots of problems with dementia diagnosis in the NHS and more cost-effective tools that can support timely and accurate diagnosis are needed. Dementia pathologies target the auditory brain and can cause early changes in auditory scene analysis, spatial hearing and degraded speech perception. DIADEM is an observational cohort study which will aims to evaluate the utility of digital auditory biomarkers to support the diagnosis of Alzheimer’s disease and stratification of patients with mild cognitive disorder in NHS memory clinics.

Inclusion/Exclusion Criteria: 

Inclusion Criteria: 

• Participant is attending a memory clinic for evaluation of whether they might be suffering from dementia OR Participant is a healthy control subject from the same age range as the memory clinic sample 
• Willingness to take part in the study 
• Participant is over 18 years of age 

Exclusion criteria: 

• Healthy controls will be excluded if they have significant neurological or psychiatric comorbidities e.g. Multiple Sclerosis, Parkinson’s Disease, Major Depression, Bipolar Disorder or Psychotic Illness  

ELFT Local Lead: Dr Nick Bass 

To learn more, contact: Email Sarah Boughetane (Lead CSO for DIADEM)