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?

Primary Question/Objective:

To establish the effectiveness and cost-effectiveness of an antidepressant medication (sertraline) for the prevention of a depressive episode following first episode psychosis (FEP).

What will I have to do?

  • The research team will assess whether you are eligible to take part (screening).
  • You are only included in screening and the main study if you formally agree to take part (give “informed consent”). 
  • After consent, you will be asked some questions about you, your health and your medical history.
  • If eligible, you are then randomly allocated to one of two groups. There is a 50:50 chance that you may or may not get sertraline.
  • We will visit you monthly for 6 months and then once at 12 months to ask you how you have been, plus a blood sample taken at 1 month only. If necessary these visits may be done by phone or video call.

What next?

Please contact us on 07917 926824 or email DHCFT.Research@nhs.net.

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.

Closed to Recruitment

What is the purpose of the study?

The primary objective of this study is to assess the safety and tolerability of intranasal esketamine in subjects with Treatment Resistant Depression, with special attention to the following:

  • Potential long-term effects on cognitive function

  • Treatment-emergent adverse events (TEAEs), including TEAEs of special interest

  • Post-dose effects on heart rate, blood pressure, respiratory rate and blood oxygen saturation

  • Potential effects on suicidal ideation/behaviour

Eligibility

To be considered for this study, you must be:

  • 65 years of age or older

  • Diagnosed with depression

  • Experiencing depression symptoms despite having taken two antidepressant medications in the past

  • Comfortable with using a nasal spray

  • Able to provide written consent to participate in the study

Recruitment to this study is now closed

What is the purpose of the study?

This research will ask people about their experiences of compulsory admission to hosital. We are looking to find ways of reducing care like this.  

Inclusion criteria

  • Male or female, aged 18 plus

  • Experience of being detained under the Mental Healt Act within the last 12 months

What will I have to do?

For more information on the Co-PACT research study please take a look at the Information Sheet

Alternatively, if you are interested in participating in the study and would like 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 the purpose of the study?

Primary Question/Objective:

Service users:

  • This study is looking at ways of improving therapies, so they are better at supporting people who self-harm

What will I have to do?

  • Meet a researcher who will ask about your health and your self-harm.  Complete 10 short questionnaires online about your well-being and 1 about money you may have spent related to self-harm. 
  • If you are allocated to the intervention group, attend 4 sessions of therapy over a maximum of 3 months. 
  • If you allocated to the standard group, you will receive the care that your Trust normally provides to people who self-harm. 
  • Respond to monthly text messages and complete further questionnaires at 3, 6, 9 and 12 months and an optional interview after 12 months.

What next?

Please contact our office on 01332 623579 or email DHCFT.Research@nhs.net.

Primary Question/Objective:

Service users:

  • What are the ownership rates and usage of digital health tools in service users with psychosis?

Staff:

  • What are the barriers and facilitators for implementation of digital health tools for staff working in a mental health setting?

What will I have to do?

You will access a survey through a QR code/web address which may take 20-30 minutes. You will also have the option to be entered into a prize draw.

What next?

If you are interested in participating in the study, further information and to check for eligibility please contact our office on 01332 623579 or email DHCFT.Research@nhs.net.

*Recently Closed for recruitment*

 

A Cluster Randomised Controlled Trial of a Ward-Based Intervention to Improve Access to Psychologically-Informed Care and Psychological Therapy for Mental Health In-Patients

What is the purpose of the study?

Primary Question/Objective:

To assess the effectiveness of a psychological service model designed specifically for acute mental health wards and determine whether it reduces the occurrence of ward-level serious incidents and improves patient wellbeing.

What will I have to do?

  • Ward staff and inpatients are invited to participate.
  • You will be asked to complete up to 8 questionnaires which should take no longer than 60 minutes to complete.
  • You will be asked to complete 5 of the same questionnaires 3 times across 9 months.
  • If you are discharged, we will come and do the questionnaires at a convenient time and location for you at 6-months and 9-months after you do the first questionnaires.
  • You will also be asked if you would like to have an optional interview (no longer than one hour long) which could take place at any point from entering the study to 12-months afterwards. 

What next?

Please email us at DHCFT.Research@nhs.net for further information.

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

Caregiving HOPE study: How being obliged, prepared and willing influences family carer wellbeing.

HOPE - Study Summary

HOPE - Carers Booklet

 

Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.

Click here to read the full report

Click here to view in NIHR Journals Library

 

LABILE - The Clinical Effectiveness and Cost-Effectiveness of Lamotrigine in Borderline Personality Disorder: A Randomized Placebo-Controlled Trial

Click here to read the full report

Click to view in The American Journal of Psychiatry

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.

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: