Clinical Research

Many people, when they think about clinical research, think about drug trials, but that is a small proportion of what we do. Clinical research is the way in which we gather evidence to improve treatments for our patients and can involve a variety of different methods including questionnaires, focus groups, testing new therapies or physical interventions such as an exercise programme. 

Promoting, conducting and using clinical research to improve healthcare is one of the key principles of the NHS. In fact, the Constitution for NHS England (2013) contains a pledge to inform patients of research studies in which they may be eligible to participate. The National Institute of Health Research wants patients and carers to feel empowered to ask about research, and to keep research at the top of the NHS England agenda. As a result, research is now core NHS business.

Our Clinical Research service works alongside our clinical teams to promote, facilitate and deliver national research studies within the Trust. The aim of the team is to make it easier for NHS staff and service users to get involved in research. We are always happy to hear from individuals that have an interest in research and want to find out more about taking part in research projects.

The studies currently running within the Trust are listed below. All have had stringent checks and ethical approval from research committees across the country.

What is the purpose of the study?

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, an NHS NIHR funded project which is part of the NIHR BioResource for Translational Research. The NIHR BioResource is a national initiative with the aim to collect genetic and clinical data from volunteers to build up a central library of information about people’s health. It offers you the chance to take part in ground-breaking research aimed at improving the lives of those not only with depression and anxiety, but other health conditions. 

What is involved?

Register on the GLAD website www.gladstudy.org.uk

Step 1: Giving consent to take part
The consent form includes a description of each of the types of activity you might be invited to take part in. It is up to you which ones you consent to.
We will request access to your medical records. Your data would only be provided to the GLAD and NIHR BioResource teams and, having been anonymised, to researchers approved by the GLAD Study, and/ or NIHR BioResource Steering Committee. We will also ask for your consent to be contacted in the future about other ongoing research studies that may be unrelated to anxiety and depression.


Step 2: Questionnaire data
We will ask you to complete some questions which will ask about your demographics (e.g. age, gender, and employment situation), emotional wellbeing, health and lifestyle, personality and experiences of depression and anxiety. This will take around 30-60 minutes to complete.


Step 3: Saliva sample
We will ask you to provide a saliva sample by spitting into a specially designed collection tube. This will be sent to you at home and you can send it back to us using a freepost envelope which we will provide.
We will extract DNA (i.e. genetic material) from this sample.
Samples will be stored without any of your personal details (e.g. name, date of birth, NHS number). 

Can I take part?

You can take part if you:

  • Are aged 16+
  • Are living in the UK
  • Have received treatment or experienced depression and/or anxiety now or in the past

Potential benefits of the study...

Once you are a member of the resource, you will be able to see information about further optional questionnaires, as well as a number of research studies that you are eligible to take part in. You may also be contacted about studies you may be eligible for that are not only related to anxiety and depression. We may assess your eligibility for these studies based on information you have provided (i.e. questionnaires), or information we have accessed from your medical records (i.e. diagnosis, treatment outcome) or samples (i.e genetic information). If you choose to do so, you can sign up to be a participant in up to four studies per year.
There may be no immediate benefit to you in terms of treatment, but you will contribute to knowledge about some of the causes of depression and/or anxiety. This knowledge may lead to better treatment guidelines and improve future care for patients.
The GLAD Study is an information resource for members as well as researchers. With this in mind, you will have access to pages dedicated to providing useful information to members.

Possible disadvantages...
Some of the questionnaires ask about topics which some people might find sensitive, and about experiences of anxiety and/or depression. You do not have to complete any questions that you do not wish to.
Providing a saliva sample is a very low risk procedure but some people find it unpleasant.
Your participation is strictly confidential and the risk of identifiable information being accidentally disclosed is extremely low.

What next?

If you are interested in participating in this study you can join up online at www.gladstudy.org.uk or for further information please contact our office on 07825 935177 or email DHCFT.Research@nhs.net.

What is the purpose of the study?

The study aims to understand if some cases of psychosis are caused by immune system problems in some people. The immune system normally controls our ability to fight infection. If the immune system goes wrong it may cause diseases called ‘autoimmune’ diseases. We can diagnose some of these immune diseases using blood tests.  

Inclusion Criteria

  • Male or Female, aged 18-70

  • Diagnosis of first episode psychotic illness, or relapse after a period of wellness

  • Symptoms for less than two years

Exclusion Criteria

The participant may not enter the study if ANY of the following apply: 
Any other neurological disorders including multiple sclerosis, epilepsy, cerebrovascular disease, hydrocephalus, traumatic brain injury, meningo-encephalitis, systemic lupus erythematosus, CNS vasculitis or primary drug-induced psychosis

What will I have to do?

You will spend 15 minutes of your time with a member of the research team discussing your illness. You will have a sample of blood taken. We will pay you £10 to compensate for the time and inconvenience.

If you are interested in participating in the study, further information and to check for eligibility please contact our office on 07825 935177 or email DHCFT.Research@nhs.net.

What is it?

Visual hallucinations, or visions, is the term used to describe seeing things that others do not. At least one in three people who have psychosis have reported seeing visions. Despite this, little is known about the nature of these experiences. Through speaking with people with lived experience, we have learned that the way in which people make sense of their visions effects the nature of their feelings.  Therefore, we are trying to understand more about the thoughts people have about their visions and the impact they can have on their lives. We want to develop a new questionnaire which will help us to identify what types of thoughts people have. We also want to explore how these thoughts relate to other psychological difficulties, such as sleep and worry. Understanding more about the way in which people make sense of their visual hallucinations, and the impact it has on their lives, will be very helpful in enabling us to develop better treatments for people with visions. 

 

What will I have to do?

 

If you decide to take part, you will then be invited to complete a pack of questionnaires which should take around an hour.  These can be completed in your local NHS clinic or at home. A researcher can support you to go through the questionnaires (this might be in person, on the phone, or via video call depending on your preference). It is your choice how to complete the questionnaires. 

 

The questionnaires cover: information about you (e.g. your age, gender); your experience of visions; your thoughts about your visions; and other feelings and experiences you may have had such as sleep or worry. This will enable us to identify if your thoughts about visions also impact on, or are impacted by, other experiences you may have.

 

You will receive a £10 shopping voucher as a thank you for taking part.

 

What next?

If you are aged between 16 – 65 and:

  • Are in contact with mental health services
  • Have a diagnosis of non-affective psychosis (e.g. schizophrenia, schizoaffective disorder, delusional disorder or psychosis not otherwise specified)
  • Currently experiencing visions (in the last 4 weeks)

then we would like to hear from you.

 

Please email bethany.williams35@nhs.net or call 07500122673 if you are interested in taking part.

 

 

What is the purpose of the study?

Primary Question/Objective:

The ANTLER 75+ Trial (Antidepressants to prevent relapse in depression in older people) is a double blind randomised controlled trial, looking at the effectiveness and cost-effectiveness of continuing antidepressant medication compared to tapering and discontinuing, in order to prevent a relapse, in adults aged 75 years and over who are taking one of three antidepressants but who are well enough to consider stopping.

Our Trust is working with local GP practices to deliver this study. Participants will be offered this opportunity from their general practice and invited to participate by way of an invitation letter and information sheet being sent to them.

 

What will I have to do?

  • You are included in screening and the main study if you formally agree to take part (give “informed consent”). You can return the consent form sent by your GP, via the post, online, or over the phone or in person with one of our research nurses.
  • The research team will assess whether you are eligible to take part (known as screening). During screening, you will be asked some questions about you, your health, and your quality of life.
  • Participants who respond to the letter, meet the eligibility criteria and sign the informed consent will be randomised to either Arm A: to continue their medication (Citalopram 20mg, Mirtazapine 30mg or Sertraline 50mg) or to Arm B: tapered off their medication before discontinuing and replaced with a placebo.
  • Participants will be assessed during the 12 months of the trial by regular assessments. These will take place by telephone, face to face, or by completing a paper questionnaire at home and posting it to the research office.
  • The primary outcome is the first relapse of depression in time-to-event analysis during 12 months of follow-up.

 

What next?

Please contact us on 07920 411 522 or email sophie.occleshaw@nhs.net to explore if your GP is working with us on this study.

 

What is the purpose of the study?

The Early Intervention Mission is a UK-wide research study aiming to better understand and improve outcomes for people experiencing early signs of psychosis, particularly those who have had a First Episode Psychosis (FEP)

The study seeks to:

  • Advance precision medicine through early intervention research.
  • Improve understanding of early psychosis.
  • Create a research register to offer future research opportunities. 

What will I have to do?

If you choose to take part, here’s what to expect:

  • Consent: You’ll be asked to give informed consent, either electronically or in person. A member of the research team will guide you through the process and answer any questions you may have. 
  • Initial Visit: This takes approximately 1 to 1.5 hours and can be completed at your home or outpatient appointment
  • Assessments:
    • Provide a blood sample (or saliva if preferred).
    • Complete a series of clinical and psychological questionnaires
  • Follow-up:
    • Use a smartphone app called CareLoop (or email link) to answer follow-up questions every six months for up to three years.
    • Allow researchers to link your data with NHS records and other national datasets (e.g. education, social care).
    • Optionally, agree to be re-contacted for future research studies. 

What are the benefits of taking part?

While there may not be direct clinical benefits, your participation will help:

  • Improve early diagnosis and treatment of psychosis.
  • Develop personalised tools to predict outcomes and tailor interventions.
  • Advance understanding of the biological, psychological, and social factors influencing psychosis.
  • Support the development of new treatments and preventive strategies.
  • Enable better resource allocation in mental health services. 

You will also receive:

  • £50 for the baseline visit.
  • £25 for completing initial questionnaires via CareLoop (baseline).
  • Additional £25 payment for the 12 month questionnaire completed via CareLoop. 

What next?

To explore whether you are eligible or to ask questions about the study, please contact:

07795 450344 f.tansley1@nhs.net

ENRICH (Enabling Research in Care Homes) is an initiative set up by the National Institute of Health Research (NIHR) to encourage more research in care homes. The Research Ready Care Home Network provides opportunities for care home staff, residents, families and researchers to come together in order to facilitate the design and delivery of research with the hope of improving quality of life, treatments and care for older people living in care homes.

We currently have over 50 care homes in Derby and Derbyshire signed up to our ENRICH tool kit, predominantly care homes for older adults but also including those for younger people with mental health difficulties and learning disabilities.

If you are interested in finding out more information about the benefits of joining your local network in Derbyshire please contact our office on 07825 935177 or email DHCFT.enrich@nhs.net

The AQUEDUCT Study

This study tested ways to improve crisis care for people with dementia, who often need hospital treatment during mental health emergencies. In the UK, special teams (TMCDs) help people with dementia stay at home during crises, but there’s no standard approach.

Researchers created an online Resource Kit to help these teams follow best practices. The study checked if using this kit would lower psychiatric hospital admissions for people with dementia and improve wellbeing for staff and service users.

Twenty-three crisis teams in England were randomly chosen to use the Resource Kit or continue with usual care. The main measure was the number of psychiatric hospital admissions over six months. The study also looked at staff wellbeing, work engagement, and satisfaction among people with dementia and their carers.

The AQUEDUCT Study Findings

The MindArise Study
This study explored how healthcare workers might socially identify with mindfulness in-groups. It explored how identifying with mindfulness in-groups might relate to thoughts about mindfulness practice. It also explored how mindfulness identities/ in-groups may or may not work well with healthcare identities/ in-groups.

The MindArise Study Findings

The MindArise Study Findings - Plain Language Summary

 

The SPS Study
The ‘SPS study’ examined the role of low intensity psychological support in helping people with complex emotional needs. 336 patients have been recruited from primary and secondary care mental health services in Avon, Buckinghamshire, Coventry, Derbyshire, East Lincolnshire, Merseyside, Oxfordshire, Warwickshire, Wiltshire, and North West London. The Study randomly allocated participants to either ‘Structured Psychological Support’ (SPS) or to ‘treatment as usual’ which includes the development of a crisis plan.

 

SPS Study Findings

The I-DIGIT Study
This study aims to investigate the impact of offering Lumi Nova as part of NHS-funded mental health services, and to explore children’s, families’ and healthcare professional's views of Lumi Nova and similar digital therapies. Our aspect of supporting of this study was too ask healthcare professionals for their opinions of offering Lumi Nova and similar digital therapies as part of young people’s mental health care.

I-DIGIT Paper 1

I-DIGIT Paper 2

The Preach Study
Prioritising Research through Engagement in older Adult Care Homes, is a project that aimed to identify research priorities by talking with key care home stakeholders. The Study then mapped these priorities with VICHTA and other data sources and promote research in these areas.  

Headline Results - PREACH

OARS
In this study, researchers wanted to learn about the effectiveness and safety of seltorexant
compared with quetiapine when either was added to existing antidepressant treatment in
participants experiencing depression with insomnia symptoms. Participants in this study were
those for whom their current antidepressant treatment was only partially effective in easing
their symptoms.
A study to learn about the effectiveness and safety of seltorexant 

UK-REACH
This study represents a unique partnership of leading researchers and clinicians with national organisations including the General Medical Council, Nursing and Midwifery Council, Royal Colleges and ethnic minority healthcare worker associations that will investigate if, how, and why, ethnicity affects COVID-19 clinical outcomes in Healthcare workers.
Discrimination, feeling undervalued, and health-care workforce attrition: an analysis from the UK-REACH study - The Lancet
More information: UK-REACH


SERVICE USERS AS PARENTS
Below is a publication related to results of a study on adult mental health service engagement with patients who are parents: Evidence from 15 English mental health trusts
https://bpspsychub.onlinelibrary.wiley.com/doi/10.1111/bjc.12330
 

ATTITUDES TO VOICES
Below is the final report for the Attitudes to Voices study - a survey exploring the factors influencing clinicians’ intention to assess distressing voices and attitudes towards working with young people who hear voices: https://www.derbyshirehealthcareft.nhs.uk/application/files/7017/1930/8895/Rammou_et_al._2023_A2V.pdf

DNA variation in adults with learning disability
Below are 2 publications that our research delivery here in Derbyshire has impacted:
https://www.nature.com/articles/ejhg2016107
https://www.cambridge.org/core/journals/the-british-journal-of-psychiatry/article/neurodevelopmental-risk-copy-number-variants-in-adults-with-intellectual-disabilities-and-comorbid-psychiatric-disorders/8AECCD39579852888E92030579A4BADC

The Feeling Exceptional study - This study aims to find out more about peoples’ experience of feeling exceptional, special, or extraordinary. This could include special abilities, identity, power, or knowledge. People with these experiences have told us that they can be positive but can also be distressing for some people. They are not currently well understood by researchers or clinicians. We are therefore trying to understand more about what these experiences are like, what keeps them going, and the impact that they have on people.
Below are 2 publications that our research delivery here in Derbyshire has impacted:
The meaning in grandiose delusions
Difficulties of grandiose delusions 


The SIREN Study - The SARS-CoV-2 immunity and reinfection evaluation (SIREN) study is a unique, large-scale partnership with NHS healthcare workers providing an agile response to an evolving pandemic. It is one of the national core studies established in response to COVID-19 and a National Institute for Health Research (NIHR) urgent priority study, and continues to provide vital research into immunity and vaccine effectiveness.
Below are 2 publications that our research delivery here in Derbyshire has impacted:
Atti, A., Insalata, F., Carr, E. J., and others. (2023) ‘Antibody correlates of protection against Delta infection after vaccination: A nested case-control within the UK-based Siren Study’ Journal of Infection DOI: https://doi.org/10.1016/j.jinf.2023.07.007

Hall VJ, Insalata F, Foulkes S, and others. ‘Effectiveness of BNT162b2 mRNA vaccine third doses and previous infection in protecting against SARS-CoV-2 infections during the Delta and Omicron variant waves; the UK SIREN cohort study September 2021 to February 2022’ Journal of Infection 2023 Nov 3:S0163-4453(23)00553-4
https://doi.org/10.1016/j.jinf.2023.10.022


Hearing nasty voices: Developing new ways to measure the experience - We delivered this study here in Derbyshire and here are some initial results to support development of an intervention:
Hearing Nasty Voices Participant Feedback


PrAISED - Promoting Activity, Independence and Stability in Early Dementia and mild cognitive impairment (PrAISED): A randomised controlled trial
Journal articles - The University of Nottingham
Video – what did the study show (2/3 way down page), this is a nice easy watch that explains the results without the jargon.
PrAISED - The University of Nottingham
The Toolkit can be found here: https://livingwithdementiatoolkit.org.uk/

IDEAL - Improving the experience of dementia and enhancing active life: a longitudinal perspective on living well with dementia
All of IDEAL’s publications and accessible summaries can be found here: https://www.idealproject.org.uk/activities/papers/ 

You can find all the resources relating to 'The World Turned Upside Down' (play and film) here https://www.idealproject.org.uk/projects/twtud/

LABILE - Clinical Effectiveness and Cost-Effectiveness of Lamotrigine in Borderline Personality Disorder: A Randomized Placebo-Controlled Trial
Click here to read the full report
Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.
Click here to read the full report


Caregiving HOPE study: How being obliged, prepared and willing influences family carer wellbeing.
HOPE - Study Summary
HOPE - Carers Booklet

If any of the studies currently running is of interest to you and you think you may be eligible, you can register your interest by completing the Expressions of Interest form. One of our Research Team will make contact; you are under no obligation to take part and can pull out of the study at any stage.

Please find our service user guide to clinical research here

Alternatively you can contact us via:

Email:  DHCFT.Research@nhs.net
Call:  01332 623579

We look forward to hearing from you.

Other ways to get involved... 

What is a Research Ambassador and what are their aims?

A Research Ambassador is a volunteer who promotes research from their perspective. They are enthusiastic about health research and are willing to explain more about research and participation to patients, staff and the public.
A Research Ambassador aims:

  • To help service receivers gain easier access to research
  • To help develop a research culture within our Trust and to embed and take research forward
  • To bridge the gap between patients, staff and the research department
  • To give personal experience and views.

Who can be a Research Ambassador?

We are always looking for Research Ambassadors - they can be patient, carer or staff. They should have experience of taking part in research and be passionate. These roles are flexible and will develop with each individual Research Ambassador's strengths.


What sort of things does a Research Ambassador do?

Take part in the Trust induction for new staff

  • Promote research projects
  • Share personal experience of taking part in research and reassure potential participants who may have concerns
  • Speak to staff about the importance of offering research to patients
  • Talk to friends, family, patients, staff and the public about research
  • Take part in events including International Clinical Trials Day
  • Support local engagement teams to raise awareness of opportunities to participate in research studies.

Marc Riley                             Click HERE to listen to Marc's Statement

Marc Riley, Research Ambassador

To learn more about becoming a Research Ambassador please email: keeleymarriott@nhs.net or call 01332 62377 ext 33407 for an informal chat.
 

What sort of things does a Research Volunteer do?

  • Data entry
  • Feasibility assessments
  • General administration duties
  • Service user perspective on new initiatives
  • Information visits.

These are just a few of the tasks a volunteer may undertake. The role will be adapted and draw on each individual's strengths and areas of interest.

Volunteering in Research - Statement

Volunteering is a good way of occupying spare time as well as gaining valuable work experience and transferable skills. I applied to volunteer in the Research and Development department because I wanted to do something interesting and engaging. Research is very important to the NHS and the wider community as it enables medical professionals to deliver the best treatments based on real-world data which is performed in a scientific and non-biased way. I enjoy working in R&D as it gives me a wide range of opportunities to help support the rest of the team as well as learn new skills.

Karl Ryan, Research Volunteer

 

For more information on our volunteering opportunities please click HERE to visit our volunteering page.

Join Dementia Research logo

 

Performance

Performance information on the initiation and delivery of clinical research

The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research. The aim is to increase the number of patients who have the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research. Providers of NHS services are required to publish information on recruitment to clinical trials and delivery to time and to target for commercial clinical trials. 

Useful links: