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.
What is it?
The purpose of this trial is to see if a new form of talking therapy called Acceptance and Commitment Therapy plus usual care can reduce anxiety in older people (aged 60+) with chronic worry that has not improved after previous treatment compared to usual care alone.
Acceptance and Commitment Therapy is a new form of talking therapy. It aims to help people learn how to live as best a life as they can with chronic worry, by helping them do things that are important and matter to them, alongside any worries or concerns they may have.
What will I have to do?
You would speak with a researcher who would discuss the trial with you and ask you some questions to find out if you are suitable to take part. If you are, you would then be asked for your consent to take part. A computer would choose at random whether you would be offered Acceptance and Commitment Therapy plus your usual care or your usual care alone.
If offered usual care alone, you would continue with your usual clinical care. If offered Acceptance and Commitment Therapy plus your usual care, you would be offered up to 14, 1-hour sessions of therapy, in addition to your usual clinical care. The sessions can take place in person or by video or phone call.
You will be followed up by a researcher at 6&12 month timepoints and will receive a £25 shopping voucher at each of these timepoints.
What next?
If you are aged 60 and over and:
- You have a diagnosis of generalised anxiety disorder
- OR you are experiencing difficulties with chronic worry
then we would like to hear from you.
Please email Joely.morgan1@nhs.net or call 07557894071 if you are interested in taking part.
*Recently Closed for recruitment*
What is it?
We are inviting people to take part in a questionnaire-based research study investigating the outcomes for patients with some memory problems, who have been referred to memory assessment services but do not receive a dementia diagnosis from their specialist. Very limited information exists on such outcomes and hence we are interested in understanding the attitudes, views, and lifestyle practices of patients immediately following discharge from memory clinics, and after a one-year period.
We would also like to understand the reason for your GP’s referral and possible changes to your lifestyle practices. Lifestyle practices are the way you live your daily life, such as your physical activity levels and dietary habits. We want to understand your attitudes, views, and any lifestyle changes immediately after visiting the memory assessment service and after a one-year period.
What will I have to do?
If you decide to take part we will kindly ask you to sign two copies of the Consent Form, keeping one for your record. We will then ask you to complete a questionnaire either online or in paper form.
In one years’ time, we may ask if you would like to complete a follow-up questionnaire
What next?
Please email Joely.morgan1@nhs.net or call 07557894071 if you are interested in taking part.
What is the purpose of the study?
Primary Question/Objective:
iACT4CARERS is an online programme tailored for family carers of people with dementia. This programme is based on Acceptance and Commitment Therapy. This new therapy is not about accepting the diagnosis or situations you are currently facing. This therapy helps people to learn how to live with difficult or distressing thoughts and feelings, while still trying to do things that really matter to them or being the type of person they want to be.
This therapy may be particularly suited to family carers due to its focus on helping people learn how to best live their lives, whilst coping with the difficulties they may be experiencing that are out of their control such as caring responsibilities.
What will I have to do?
- So long as you are aged over 18, caring for a family member with dementia, wish to accept this type of support, have internet access, and are not currently accepting CBT or counselling [being on a waiting list is acceptable] you are eligible to participate. Interpreters can be provided if required as the therapy is delivered in English.
- If you verbally express an interest in participation, you will be requested to provide your contact details to permit the study team to make contact with you.
- The study team will make contact to confirm eligibility, and receive your verbal consent to participate
- The study team will run through a screening process to proceed with partaking in the study. This involves some questionnaires about yourself, your thoughts and feelings regarding your caregiving role.
- If you are eligible, you will be randomly allocated by computer to receive either iACT4CARERS plus your current treatment OR your current treatment alone (no iACT4CARERS). You will have an equal chance of being allocated to either of the groups. Your current treatment refers to any type of support you are currently receiving from health and social care services. You can continue to access support you are currently receiving during the study.
- Participants allocated to receive iACT4CARERS will be given a link to the iACT4CARERS website and login details to access the programme. You will be asked to complete eight online sessions in 12 weeks from this. You will lose access to iACT4CARERS after 12 weeks if you have not completed all eight sessions.
- Each session will take 40-60 minutes of self-study time. If you need to stop during the session, you can always come back to it at any time and start from where you left off last time. Your dedicated therapist will provide feedback and answer your questions online every week. You will also be invited to book a one-to-one session with your therapist at the start of the programme, and another one-to-one session a few weeks after this.
- In order to examine how helpful iACT4CARERS is for family carers, you will be asked to complete the same questionnaires about yourself and your thoughts and feelings regarding your caregiving role that you completed at the beginning at 12 and 24 weeks after you start the study. Each follow-up assessment should not take more than 50 minutes to complete.
- It is really important that you try to complete all follow-up assessments, regardless of whether you are allocated to receive iACT4CARERS or not, and even if you stop completing the online programme. This ensures we have all the information we need to properly test how well iACT4CARERS works in improving the well-being of family carers. You will be entered into a prize draw to win one of 50 £20 gift vouchers for completing follow-up assessments, regardless of whether you are allocated to receive iACT4CARERS or not.
- Some participants from the group allocated to receive iACT4CARERS will also be invited to take part in an individual interview at the end of the study. This interview part is optional, and you will receive further detail and be asked to consent to take part in the interview session separately if invited.
What next?
Please contact Sophie on 07920 411 522 or email sophie.occleshaw@nhs.net to if this is something you wish to find out more about.
*Recently Closed for recruitment*
What is it?
We are conducting the first ever large-scale randomised trial to examine the effects of a low-intensity psychological intervention for people with probable personality disorder.
We are asking for your help to find out whether SPS improves the mental health and social functioning of people with complex emotional needs. SPS consists of 6 to 10 sessions of person-centred psychological support and will be compared with treatment as usual plus a single session of person-centred crisis planning. Participants will be followed up for a year, and will receive £50 gift vouchers to thank them for their time.
What will I have to do?
Once you have consented to take part in the study, we will ask you to complete some questionnaires that will tell us about your current mental health, and let us know whether you are eligible to take part in the study. This assessment process should take 20-25 minutes to complete. If you are not eligible for the study this does not mean that you cannot be helped, only that we are testing this particular intervention in people with difficulties that are different to yours.
Allocation to a study group
If you are eligible for the study, you will be put in either group A (Structured Psychological Support) or group B (usual care) based on chance. A computer will randomly allocate you to one of the groups. Around half of the people who take part will be in group A and offered SPS and around half will be allocated to group B and receive usual care. We have designed the study to ensure that everyone who takes part has an equal chance of being in group A.
People in both groups will continue to have access to mental health services. We will make sure that everyone in the study has a crisis plan. So, if you don’t already have a crisis plan we will arrange for someone to work with you to complete one. We ask that you do not receive psychological treatments for complex emotional needs during the 12 months of the study, although your clinical team can choose to put you on a waiting list to start this type of treatment after your participation in the study has ended. You can still receive psychosocial interventions and psychological treatments for other mental health problems such as anxiety and depression during the study if the clinical team believe that these are suitable for you.
What next?
Please contact on gemma.harrison3@nhs.net if you are interested in finding out more.
What is it?
The purpose of this study is to explore service user, staff and carer experience with a view to identifying how health and social services can improve the care they offer to people from diverse ethnic groups, living with psychosis and multiple long-term conditions and produce resources that help them do that, and explore if improvements are delivered locally.
What will I have to do?
If you or someone you support is likely to be eligible for this project (having a psychotic illness and 2 physical comorbidities eg. cardiovascular, respiratory, liver, kidney diseases, diabetes) please get in touch with the research team.
The research team will then check if you or the person you support is eligible to take part and offer you information about the study so you can think about whether you want to take part. The research team will also ask if it is okay to contact you and send you more detailed information about the workshops for example dates and times.
If you have the health conditions which make you eligible you will be invited to a series of 3 workshops during which you will be engaged in and supported with a photography project exploring and capturing your experiences of managing your mental and physical health and accessing services. You can attend these online or at a local venue. There is a £20 payment per workshop attended for those with the conditions and an optional exhibit of your images if you consent for this. Travel costs can also be reimbursed.
The study team is also interested in the experience of carers, family and staff who support people with these conditions and will hold similar online workshops for them to capture this. A staff survey will be available at the beginning, middle and end of the project to gauge whether improvements are being implemented.
What next?
If you or someone you support has;
a psychotic illness and
physical health comorbidities
Or if you work in health or social care and have particular interest in supporting us with this project.
Please contact rosemary.brodie@nhs.net or call 07990426305
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?
This study is recruiting those aged 18+, in the community, who do not currently complete <150minutes of moderate-vigorous physical activity per week.
‘Snacktivity’ promotes physical activity throughout the day to accumulate a total of 150mins across the week,
with the use of ‘Activity Snacks’.
‘Activity Snacks’ lasts 2-5 mins, such as:
Calf raises whilst the kettle boils,
Bicep curls with a tin of beans,
Having a disco in the kitchen whilst cooking!
Such activities develop the participant’s confidence to be more physically active, by encouraging small changes to initiate and maintain these habits.
Eligible participants will be randomised to receive either:
The ‘Snacktivity’ intervention, (from a trained Healthcare Professional) and provided with a Fitbit, and access to the ‘SnackApp’!
Or usual care, where their Healthcare Professional will discuss standard NHS Physical health elements.
Participants allocated to the intervention arm get to keep the Fitbit, & regardless of whether they are randomised to ‘usual care’ or the intervention of ‘Snacktivity’; and ALL participants receive a total of £40 throughout the duration of the study!!
What will I have to do?
Interested staff would be ‘trained’ to deliver the intervention, by watching a 15minute video (with a cuppa!).
Once ‘trained’, the study can be mentioned during a client’s routine appointment – to not extend the workload for staff or require any additional appointments to be made.
What next?
If you have clients of your caseload who are aged 18+:
Do not currently complete over 150minutes of moderate-vigorous exercise a week
are not inpatients or bedbound
then we would like to hear from you, to 'train' you to offer this study to your clients.
Please email Sophie sophie.occleshaw@nhs.net or call 07920 411 522, or Dawn dawn.jameson2@nhs.net / 07500 122 673 if you are interested in offering this study to your clients.
*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.
Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.
Click here to read the full report
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
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/
Here is a sample accessible summary: https://www.idealproject.org.uk/media/universityofexeter/schoolofpsychology/ideal/laysummaries/IDEAL_positive_experiences_in_caregiving_accessible_summary.pdf
You can find all the resources relating to 'The World Turned Upside Down' (play and film) here https://www.idealproject.org.uk/projects/twtud/
The Toolkit can be found here: https://livingwithdementiatoolkit.org.uk/
This issue of the Journal of Dementia Care features our co-written article 'The IDEAL Living with Dementia Toolkit: Living your life with hope': https://artsincarehomes.org.uk/wp-content/uploads/2023/02/Journal-of-Dementia-Care-ND-AICH-2022.pdf
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
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
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
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:
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
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:
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
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.
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 Join Dementia Research logo](/application/files/7415/6162/8814/JDR_logo.png)
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.
- Download our performance for 2022-23
- Download our performance for 2021-22
- Download our performance for 2020-21
- Download our performance for 2019-20
- Download our performance for 2018-19
- Download our performance for 2017-18
- Download our performance for 2016-17
- Download our performance for 2015-16
- Download our performance for 2014-15