AQUEDUCT: Achieving Quality and Effectiveness in Dementia Using Crisis Teams

Who this study is aimed at?

Service users and their carers who have recently used a team that works with people who have dementia and who have experienced a crisis.

Who can't take part?

Service users and their carers without a diagnosis of dementia.

Study summary 

This research study is looking at the use of a resource kit in practice with Teams Managing Crisis in Dementia (TMCD). The resource kit is for use by teams with people with dementia and their carers at times of crisis.  

Study visits 

A one-off interview by a researcher with the person who has dementia and separately with their carer. This will take approximately 30 minutes for each interview and will take place by phone or online via laptop or tablet.  

Services taking part

Older Adults services based at Edmund Road.

Who to contact  

Hannah Gower (hannah.gower@shsc.nhs.uk)

BART II: Bipolar At Risk Trial II

Who this study is aimed at?

Researchers are inviting people to take part in the study if they are experiencing mood swings and aged between 16 to 25. This may mean that at times you feel high in mood, which can include feeling energetic, activated and talkative. However, at other times you may feel low in mood which may mean you feel sad, tired, lacking in energy and get less pleasure from the things that you used to enjoy.

Who can't take part?

  • History of a treated/untreated manic episode or psychosis of 1-week duration or longer
  • Treatment with a mood stabiliser for longer than 6 weeks or antipsychotic for 3 weeks
  • Organic brain disorder
  • Inpatient/acute psychiatric care needed - Primary substance abuse / dependency

Study summary 

Health services are beginning to recognise that it can be helpful to provide treatment and support to people who are starting to experience psychological distress. Such treatment may help to reduce the feelings of distress being experienced and may prevent people’s distress from worsening. Recent research has shown that identifying people who experience mood swings early on can prevent these problems from becoming worse.

Cognitive Behavioural Therapy (CBT) is a talking therapy which focuses on the way people think. This approach states that our thoughts and beliefs may be linked to our moods, behaviour, physical experiences and to the events in our lives. Cognitive therapy sees these things as being interlinked but emphasises our thoughts and beliefs as the area to focus on. An example of a different approach would be a medical doctor’s emphasis on our physical experiences as the main area of focus.

The thoughts we have about an experience, or the way we interpret it, has been shown to have a powerful effect on our emotional, behavioural and physiological responses – that is, what we feel, what we do and what our bodies do. This is a central theme for cognitive therapy and is used widely for a range of problems.

Recently criteria have been developed to identify the experiences of individuals who have mood swings and are therefore considered at risk of developing Bipolar Disorder. These criteria are called Bipolar At Risk (BAR). This study would like to extend previous research by using the criteria to identify people with these experiences and find out if offering them a new kind of CBT (called CBTBAR) is helpful.   

Study visits 

You will be invited to meet with a member of the team to discuss the study and complete a ‘detailed assessment’ to check that your experiences meet the criteria for our study. At this appointment, the research assistant will first go through the information in this sheet once more with you and answer any questions you may have. If you still wish to take part you will be asked to read through and sign a consent form.

The research assistant will then ask you about the problems you are experiencing. They will ask you about the nature of these problems and how they affect your life. You will also be asked to complete questionnaires. This interview may take around 2 hours. The research assistant will offer you as many breaks as you need and the assessment can be spaced over two visits if you prefer.

If you meet the criteria, we will arrange to see you again for three follow-up appointments.  These will be planned for 4, 6 and 12 months after your initial appointment and will be very similar to the initial assessment. The research assistant will also contact you after 9 months for a quick check-in phone call. In addition, you may also be asked to take part in the CBTBAR intervention.

Services taking part

Various Trust-wide, including:

Limbrick Health Centre

Netherthorpe House

Northern General Hospital

Who to contact  

Rosie Duncan: rosie.duncan@shsc.nhs.uk

Alex Carey: alex.carey@shsc.nhs.uk

CCiC: Continuing Compassion in Care

Who this study is aimed at?

Family (or friend) carers of someone living with dementia (no minimum contact level but must self-identify as a carer). 

Health and social care professionals who support family carers including community psychiatric nurses, social workers, Admiral nurses and support workers.

Must be aged 18 or over (no upper age limit).

Who can't take part?

Those unable to read and speak English

Study summary 

In the UK there are 670,000 family and friends caring for someone living with dementia or memory problems. We know that family carers provide long term care with little support from health and social care services. We know that family carers experience self-critical thoughts, depression, anxiety and grief.

These experiences may be related to their levels of compassion for themselves and others. We know self-compassion is related to better psychological well-being but what we don’t know is how we can help family carers to maintain compassion for themselves and for others when faced with difficult situations.

Using this information the research team will be designing and testing a tool to measure family carer’s experiences of compassion. They will also be designing an intervention with family carers for family carers on ways we can support and maintain compassion whilst caring. This three year study comprises of five workstreams.

Study visits 

Participants will be able to take part in interviews, workshops or surveys.

Services taking part

Grenoside Grange

The Longley Centre

Who to contact  

Charlotte Colbeck: charlotte.colbeck@shsc.nhs.uk

CLEAR: Clozapine in early psychosis (CLEAR): a multi-centre, randomised controlled trial of clozapine for young people with treatment resistant psychosis in real world settings

Who this study is aimed at?

  • Age ≥12 and <25 years at randomisation
  • Meets criteria for schizophrenia or related disorder,
  • Experienced treatment resistance
  • English or Welsh language sufficient to participate

Who can't take part?

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

Study summary 

Research on antipsychotics in young people and children shows that antipsychotics do help children and young people with psychosis.  However, there is very limited research focussed on clozapine in young people, so it is not clear whether or not clozapine should be recommended for people under 25. For these reasons, the National Institute of Health Research (NIHR) has commissioned this research to study clozapine as a treatment for psychosis in people under 25.

The results will help the National Institute for Health and Care Excellence (NICE) decide which treatment they should recommend, so it should help other people to receive the best treatment in the future.

Study visits 

The researcher will ask you some questions to confirm that you are eligible to participate in the study, and afterwards a computer will randomly decide whether you are prescribed clozapine or another antipsychotic for 12 weeks.  

Participants who are allocated to take clozapine will follow their local NHS Trust clinical practice and may be required to be admitted. Your clinical team and researcher will explain this in more detail if required.

Participants who are not allocated to clozapine will be allowed to take any other antipsychotic. The decision regarding type and dose of this antipsychotic will be made by the doctors treating you.

This study involves 4 visits with a researcher, who will aim to meet you wherever you usually receive your clinical care (e.g. in hospital, at a clinic or community team base). Each visit will take 1 – 2 hours, you will be able to have a break if you wish to do so.

The research psychiatrist will assess your symptoms and side effects via a video-call that the researcher will help you set up. The videolink will be encrypted (i.e. data is converted into code, to prevent unauthorized access). No online conversations or assessments will be recorded.  

The research psychiatrist will not know which medicine you are taking and it is important that you don’t tell them as this could bias the results.

Services taking part

  • Limbrick Health Centre

Who to contact  

Rosie Duncan (rosie.duncan@shsc.nhs.uk)

COBALT clinical trial: COmBining memantine And cholinesterase inhibitors in Lewy body dementia treatment Trial (COBALT) clinical trial

Who this study is aimed at?

The trial will look at the use of a drug called Memantine for treatment of people with Dementia with Lewy Bodies (DLB) and Parkinson’s Disease Dementia (PDD) symptoms. Potential participants should be currently taking cholinesterase inhibitors

Who can't take part?

Patients taking memantine, amantadine, ketamine, or dextromethorphan.

Any neurological or major psychiatric diagnosis that may be contributing to cognitive impairment above and beyond that caused by the patients DLB or PDD.

Study summary 

The aim of the trial is to find out if Memantine treatment can help improve overall health and functioning for people with DLB or PDD. 

If you agree to take part you will  join one of two trial treatment groups for 12 months: a placebo (‘dummy’ drug) group OR a medication (Memantine) group

Study visits 

You will have planned visits and phone calls with the local trial team, who will ask you about your symptoms, how you feel and your study treatment. A family member or person who knows you well will also be asked to answer questions about your symptoms and about how they are feeling.

Services taking part

The Longley Centre

Who to contact  

Amanda Bennett: amanda.bennett@shsc.nhs.uk

CognoSpeak: An automated cognitive assessment tool based on language (utilising automated speech recognition and Machine Learning)

Who this study is aimed at?

Healthy volunteers

People with memory problems

People with Parkinson’s disease

Stroke survivors

Who can't take part?

People who lack the capacity to give informed consent.

People who are unable to communicate and understand written or spoken English sufficiently enough to follow the consent process.

People with very impaired speech production, such as severe dysphasia.

People with severe motor impairment that means they cannot respond to questions or ask for next question even with help of care-partner.

Study summary 

This study is developing a new computer program to help improve the quality of care for people who may be experiencing changes to their thinking and memory.

The aim of this study is to understand whether patients with either memory complaints or suspected movement disorders (such as Parkinson’s disease), those who have suffered a Stroke and healthy volunteers can talk to a computerised doctor (CognoSpeak) regarding their neurological health.

CognoSpeak is a computerised doctor i.e. a human looking image on a computer screen that will ask you questions regarding your health. CognoSpeak will not be able to respond to your answers. The answers will be analysed by a computer program to look for changes in speech patterns due to memory problems and/or mood. CognoSpeak will ask healthy volunteers the same questions as those with either memory complaints, suspected movement disorders or stroke, so that we can compare answers between different groups of participants with cognitive complaints.

This study looks at how people with cognitive or memory problems describe their difficulties in daily life. We are also interested to see how your speech pattern may change over time. At present it often takes a long time before memory problems are diagnosed accurately. 

Study visits 

The Study will involve having a conversation with a virtual computerised doctor This will either be in person with a researcher or via your computer from your own home.

You will be asked to undertake some routine mood and thinking assessments. The research team would like some participants to repeat the assessment every 6 months for a few years but you can take part just once

Who to contact  

Ask your Doctor, Nurse or Therapist about the study

Email the Cognospeak Study team: sth.cognospeaksth20818@nhs.net

call them on 0114 226 8530

Connecting Community Mental Health Support

Who this study is aimed at?

People aged 18 years old or above and have used mental health services in the last 2 years

Who can't take part?

Service users Potential participants will be unable to take part if they, 1) are aged under 18; 2) have not accessed primary, secondary, or social care, or VCSE services for support with their mental health within the 24 months preceding the interview/workshop; 3) have not accessed a service for mental health support within BNSSG or SYB areas. Advocates Advocates will be unable to take part if they do not work in a BNSSG or SYB advocacy group. Service providers and system leaders Staff will be unable to take part if they do not work in a BNSSG or SYB service that provides mental health support or advocacy or leads on the provision of mental health support.

Study summary 

This research study aims to inform how to make different mental healthcare services work better together to improve mental health and reduce mental health inequalities.

Study visits 

We will invite service users, advocates, service providers and system leaders to take part in interviews and a series of workshops.

In the first workshops, the research team will ask participants to work in groups to suggest how connections between different mental health services can be improved. The second workshops will give participants the opportunity to refine ideas from the first workshops and produce recommendations for change. Stakeholders (i.e., service providers, policy makers and commissioners) will create action plans based on these recommendations in an action planning meeting. Each workshop will last around 2 hours.

The interviews, lasting about 1 hour, will investigate participants’ experiences and views of integrated mental healthcare, barriers and facilitators to integration, and improvements that can be made to create a more integrated system, and reduce health inequalities. 

Who to contact  

Alex Carey: alex.carey@shsc.nhs.uk

CONTACT-GAD: A randomised CONtrolled trial of Tailored Acceptance and Commitment Therapy for older people with treatment resistant Generalised Anxiety Disorder

Who this study is aimed at?

  • 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).

Who can't take part?

  • 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, 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.

Study summary 

In a previous study, the study team adapted a new form of psychological therapy called Acceptance and Commitment Therapy for older people with treatment-resistant generalised anxiety disorder (TR-GAD). The purpose of this trial (CONTACT-GAD) is to see whether adding this therapy to usual care is helpful for reducing anxiety in older people with TR-GAD compared to usual care alone. The study team also want to see if this therapy is good value for money in comparison to usual care alone.

Acceptance and Commitment Therapy is a form of talking therapy that helps 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. It has been found to be helpful in other conditions including depression and chronic pain and may be particularly suited to older people with TR-GAD.

Study visits 

Eligible participants with TR-GAD will be randomised in a 1:1 ratio using a web-based, centralised randomisation system hosted by the Sheffield Clinical Trials Research Unit (CTRU).

Participants randomised to ACT plus usual care will be offered up to 14 individual (i.e. one-to-one) sessions of tailored ACT over 6 months plus a booster session approximately 3-months post-intervention (i.e. approximately 3 months after the final ACT session), with each session lasting up to 1 hour.

Services taking part

  • Northlands Community Health Centre
  • East Glade Centre
  • Older Adults Home Treatment

Who to contact  

Hannah Gower (hannah.gower@shsc.nhs.uk)

Rosie Duncan (rosie.duncan@shsc.nhs.uk)

CPM2 - Support for medics to manage occupational burnout

Who this study is aimed at

  • GMC registered doctors from any areas of specialty and NHS healthcare services, including trainees on rotation in NHS services. They can be working either part-time or full-time in a clinical role.

Who can't take part?

  • Doctors currently accessing or referred to any concurrent psychological intervention delivered by a mental health professional (this specifically refers to talking therapies for mental health problems)
  • Doctors that are currently not in active clinical service at the time of recruitment (e.g. on sick leave, maternity leave or suspended for any reason)
  • Doctors that work in a purely managerial, supervisory or educational role (e.g. not in clinical practice at the time of recruitment)

Study summary 

The purpose of the CPM Trial 2 is to assess the effects on the health and wellbeing of NHS doctors of a psychological intervention called Mind Management Skills for Life Programme. Occupational burnout and associated mental health symptoms are known to affect around 44% of UK doctors. Previous studies show that burnout has a negative impact upon psychological wellbeing and physical health, as well as being associated with poorer job performance. Burnout is also associated with poorer patient treatment outcomes. We know how crucial it is to address and improve wellbeing in the workforce and the aim is to evaluate whether the Mind Management Skills for Life Programme can do this.

Study visits 

This survey will take approximately 10-15 minutes to complete. It contains three sections that you need to complete to register as a study participant.

The first section provides a detailed information sheet explaining what the study is about. The second section covers a formal consent form that you should complete to register.

Finally, you will be asked to complete a brief set of anonymised questionnaires including demographic and occupational information (e.g. age, ethnicity, job role).

Services taking part

  • Trust-wide

Who to contact  

Message jo.wilson@shsc.nhs.uk for further information.

Use this link to complete the survey 

 

DIAMONDS Randomised Control Trial - Improving diabetes self-management for people with severe mental illness

Who this study is aimed at?

Researchers are inviting adults over 18 to take part who have been diagnosed with: Type 2 diabetes and a mental illness such as: Bipolar disorder Schizophrenia Schizoaffective disorder Severe depression Psychosis

Who can't take part?

Those who have cognitive impairments, gestational diabetes, type 1 diabetes, diabetes due to genetic defect or secondary to pancreatitis or endocrine conditions, lack of capacity, or inpatients.

Study summary 

Self-management (which includes taking medications, monitoring symptoms, preventing complications, and leading a healthier lifestyle) is an important part of staying well with a long-term condition. There are many self-management programmes in the NHS to help people with long-term conditions look after themselves, but they often do not address the challenges of people who also have a severe mental illness.

The DIAMONDS research programme aims to overcome this problem by developing and testing a self-management intervention that can specifically help people with diabetes and severe mental illness to be healthier. The intervention has been developed in partnership with people with mental illness and diabetes, their family members/friends, and the healthcare staff who support them. It has been designed to address challenges to self-management, which include poor motivation due to mental illness symptoms and medication; limited support from others for self-management; beliefs about their ability to engage in self-management; and limited knowledge and skills for long-term condition management.

Study visits 

The DIAMONDS intervention is a 6-month programme that consists of daily self-management tasks and 1-to-1 meetings with a trained facilitator, who is called a DIAMONDS Coach.

Services taking part

East Glade Centre

Edmund Road

Limbrick Health Centre

Northlands Community Health Centre

Who to contact  

Elissa Thompson: elissa.thompson@shsc.nhs.uk

Alex Carey: alex.carey@shsc.nhs.uk

Digital health tools in psychosis: A survey study

Who this study is aimed at?

  • You have received either a diagnosis of, or treatment for, psychosis or schizophrenia or unusual distressing experiences (e.g. hearing voices, having unusual beliefs),
  • Are aged 18 or older
  • Able to understand and speak English

Who can't take part?

  • Not sufficiently fluent in English to complete the survey.

Study summary 

In this study, The study team wish to understand what you think about using digital devices like a smartphone (e.g. Android phone or iPhone) or wearable device (e.g. Fitbit or smart watch) to help you manage your mental health. They want to understand your overall views on this topic and how you use digital devices.

Study visits 

You will be asked to complete a survey (either online or in paper format). The survey will ask about your opinions and use of digital devices and how they can be used in mental healthcare. The survey takes between 20 – 30 minutes to complete. All your responses will be anonymous, and there will be no way of identifying you from the questions in this survey.

Services taking part

  • Trust wide

Who to contact  

Rosie Duncan (rosie.duncan@shsc.nhs.uk)

EDGI: Eating Disorders Genetics Initiative

Who this study is aimed at?

People age 16 and over who have eating disorders including anorexia nervosa, bulimia nervosa and binge-eating disorder.

Who can't take part?

People who don't have a current eating disorder.

Study summary 

Eating disorders are severe psychiatric illnesses and are associated with one of the highest mortality rates within mental health.  To improve understanding of the genetic and environmental risk factors behind eating disorders, researchers need to recruit thousands of participants.  This project is led by the National Institute for Health Research (NIHR) BioResource Centre Maudsley (part of the NIHR BioResource), researchers at King's College London and Beat, the UK's eating disorder charity.  

Study visits 

Completion of a consent form, questionnaire taking 30-45 minutes to complete and providing a saliva sample; the kit for which will be sent to your home.

Services taking part

Eating Disorders

Who to contact  

Jo Buckley (jo.buckley@shsc.nhs.uk

FReSH START: Function REplacement in repeated Self-Harm: Standardising Therapeutic Assessment and the Related Therapy (WP4 - Randomised Controlled Trial)

Who this study is aimed at?

People aged 18 or over who have self-harmed a number of times and have recently approached services.

Who can't take part?

People who are receiving, or having been referred to a psychological intervention (and likely to receive this within the next 6 months), that is similar to this study, or where an intervention is for a related condition (eg anorexia nervosa).

People who have already taken part in the FReSH START feasibility study.

Study summary 

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

Study visits 

Meet a researcher who will ask about your health and your self-harm.  This meeting can be in-person, on the phone or via video call.  The meeting will take about 1 hour.  

You will then be asked to complete a set of 4 short questionnaires about your well-being, and one about money you may have spent related to self-harm.  These questionnaires are completed on-line, though the researchers can provide paper versions if required. Filling in the questionnaires will take around 1 hour of your time.

You will be able to nominate a close friend or relative whom the researchers can get in touch with in the event that they cannot contact you in future.  The researchers will send you an information sheet and consent form to pass on to your friend or relative; this is optional and can be done at a later date.  

If you are allocated to the intervention group you will need to attend up to 12 sessions of therapy with a trained therapist for up to 6 months.  These sessions will each take around 45 minutes.  The sessions will either take place at your local NHS Trust premises or via phone or video call.  The method used for these sessions will depend on your preference, the preference of the therapist as well as current guidance within your local NHS Trust.  If necessary there will be one or two optional telephone booster sessions as part of the trial.  Therapy sessions will be audio-recorded by the therapist, so the researchers can monitor therapist training and ensure quality of the therapy.

If you are allocated to the standard care group you will receive the care that your local NHS Trust normally provides to people who self-harm.  The researcher will be able to tell you more about what the standard care in your Trust involves.

You will need to respond to monthly secure text messages to let the researchers know how you are doing, and whether you have self-harmed in the last month. 

You will need to complete the same set of questionnaires you filled out at the start of the study, after 6 and 12 months.  

You will also need to complete a shorter questionnaire at 3 and 9 months about hospital attendances, appointments and contacts with other services.

The researcher may invite you to take part in an optional interview after 12 months so that you can tell them about the therapy you received.  

Services taking part

A&E Liaison

Decisions Unit

Who to contact  

Jo Buckley (jo.buckley@shsc.nhs.uk)

INVITE: INcorporating VoIce acTivated communication aids into Everyday communication

Who this study is aimed at?

  • Over 18 years of age
  • Moderately or severely dysarthric 
  • Minimum of 2 distinct vocalisations over which they have voluntary control
  • Able to give informed consent and take part in interviews with appropriate communication support
  • Communicates predominantly in English

Who can't take part?

  • Significant cognitive impairment and are unable to give informed consent on their own behalf or actively take part in interviews, or are unable to use a communication aid.
  • No controlled vocalisations.
  • Dysarthria as the result of a progressive condition.

Study summary 

Developments in speech recognition technology have led to apps which can learn to recognise a set of words or sounds spoken by the individual with dysarthria, and connect these with a clear spoken output, known as voice input voice output communication apps VIVOCAs). Our previous research provides some evidence that VIVOCAs may be faster than traditional communication aids.

We would like to find out more about who will benefit from this technology, how they will use it, and what support they need to use it. This will help us to make sure that the people who could benefit from this app will get the opportunity to try it, and get the support they need to use it to help them.

Study visits 

A member of the research team will meet with you at your home or another place of your choice, or at Barnsley District General Hospital, or the University of Sheffield to help you to decide which of the available apps is most suitable for you. They will bring with them the equipment you will need, and help you to set the app up to say the things you want it to say. This should take 1-2 visits of around 1 hour each.

In the next visits you will be asked to try out some tasks with the app, and asked lots of questions about how you feel about your communication, and what you would like to achieve with the app. This should also take 1-2 visits of around 1 hour each, with as many breaks as you need.

The team will also come and see when you have had the app for 3 months, and again at 6 months when your time in the study will end. These visits will be similar to the first one you had - the researcher will collect the same information again, to see if the app has helped you. You will also be asked some questions about how easy you found the app to use.

Services taking part

  • Michael Carlisle Centre

Who to contact  

Kate Fryer (k.fryer@sheffield.ac.uk)

 

I-RAP: Improving Recognition and understanding of Autism and Personality disorder

Who this study is aimed at?

Women age 18 and over who have been diagnosed with an autism spectrum condition or self-identifying as autistic. 

Women aged 18 and over who have been diagnosed with a personality disorder.

This includes people who fit into both groups and people currently identifying as fully or partly female, and people assigned female gender at birth and now identifying differently.

Who can't take part?

People who have been diagnosed with a schizophrenia-spectrum disorder or have moderate to severe learning difficulties.

Study summary 

Getting a diagnosis that feels right for you can be an important part of being able to understand yourself and your experiences.  But sometimes one diagnosis can look similar to another, and it can be difficult to tell them apart.  In particular, the similarities and differences in experiences of autistic people, and people who have difficulties associated with the diagnosis of 'personality disorder' can be confusing and are currently not clear.

Study visits 

Questionnaires taking approximately 20 minutes, talking through your answers with a researcher taking approximately 90 minutes and chatting about your experiences taking approximately 60 minutes.  

These can be done at intervals to suit you.  

Services taking part

Trust-wide

Who to contact  

Elissa Thompson (elissa.thompson@shsc.nhs.uk)

Alex Carey (alex.carey@shsc.nhs.uk)

NoDem: Practices, attitudes and outcomes of people with memory problems but no diagnosis of dementia

Who this study is aimed at?

People who have been referred by their GP to memory assessment services but do not receive a dementia diagnosis from their specialist.

Who can't take part?

People who have been given a dementia diagnosis from memory assessment services.

Study summary 

This study wants to understand the attitudes and views of patients with memory problems who are referred to a memory assessment service by their GP but who do not receive a dementia diagnosis from their specialist. Researchers would also like to understand the reason for the GP's referral and possible changes to lifestyle practices.

Lifestyle practices are the way people live their daily lives, such as physical activity levels and dietary habits. This study will look at attitudes, views and any lifestyle changes immediately after visiting the memory assessment service and after a one-year period.

Study visits 

A questionnaire which can be completed online or on paper. After one year, a follow-up questionnaire can be completed.

Services taking part

Memory Service

Who to contact  

Catherine Kerr: catherine.kerr@shsc.nhs.uk

Hannah Gower: hannah.gower@shsc.nhs.uk

Social Environment and Early Psychosis: An Urban Mind Study. Using smartphone-based monitoring to understand and predict risk of psychotic relapse at the individual level

Who this study aimed at?

Anyone aged 16-40 years old who has recently experienced their first ever episode of psychosis and who has access to a smartphone and the internet.

Who can't take part?

People who have experienced an episode of psychosis on more than one occasion, or are unable to make a rational decision whether or not to participate in the study, or do not have access to the internet and a smartphone.

Study summary

Psychosis affects 2-3% of the population and is a severely debilitating disorder. Urban Mind have developed a smartphone app which monitors patients who have recently had their first episode of psychosis and measures their daily social stress.

Study visits

An initial assessment and follow-up assessments at four, eight and 12 months as well as daily app notifications.

Services taking part

Limbrick Centre.

Who to contact

Paul Lynch (paul.lynch@shsc.nhs.uk)

Charlotte Colbeck (charlotte.colbeck@shsc.nhs.uk

Find out more

www.urbanmind.info

STRATA: A multicentre double-blind placebo-controlled randomised trial of SerTRaline for AnxieTy in adults with a diagnosis of Autism (STRATA)

Who this study aimed at?

Adults aged 18 years or over and have a diagnosis of autism (including autism spectrum disorder/condition or other variations, Asperger syndrome or pervasive developmental disorder).  Also have experience anxiety for which you are willing to try treatment with medication. 

Who can't take part?

The study may not be suitable for you to take part in if you are/have:

  • Currently taking medication(s) for depression and/or anxiety, or have taken them in the past 8 weeks. (We will check this information with your doctor if you want to take part) or using St John’s Wort.
  • Have a moderate or severe learning disability which means you may not be able to provide informed consent and/or understand and complete the study questionnaires.
  • Have/had other mental health conditions such as bipolar disorder or psychosis.
  • Epilepsy that is not well controlled.
  • Current problematic use of alcohol or illicit drugs.
  • Allergies to sertraline or placebo.
  • Severe liver problems, bleeding disorders, some heart problems swallowing difficulties or are unable to take medication in capsule form.
  • Taking part in another clinical trial.
  • Pregnant, planning pregnancy during the study period, or breastfeeding.

Study summary

The STRATA study aims to find out whether the medication sertraline is an effective treatment for anxiety in adults with a diagnosis of autism.

A lot of autistic adults experience anxiety and many find it very difficult to deal with. Medications like sertraline are often prescribed for anxiety in autistic adults but whether they work, and what their side effects are in the autistic population is not well known. Although such medications are well studied in the general population, those research findings may not apply to autistic adults. It is important that any medication prescribed to autistic adults is based on research evidence.

The study team are interested to see whether sertraline reduces symptoms of anxiety, enhances quality of life, and is effective in the longer term.

We are also interested in understanding side effects of the treatment, what people think about being invited to the study, and their experiences of taking part in it.

Study visits

People who take part will receive either sertraline, or a placebo (inactive) medication in capsule form. They will be asked to take it for up to one year. Please note that the medication capsules may contain gelatine which may not be suitable for vegans.

Participants will be contacted briefly by trained study staff via video call, telephone, text or email (whichever you prefer) at 1 to 2, 4, 8, 12 and 36 weeks after you join the study, to see how you are getting on with the medication.

Participants will be asked to complete questionnaires at baseline (week 0), 16, 24 and 52 weeks after you join the study.

The questionnaires will ask about your anxiety, other symptoms, and healthcare usage. To thank you for your time, we will offer you a £10 gift voucher upon receipt of each completed questionnaire.

Who to contact

Rosie Duncan rosie.duncan@shsc.nhs.uk

Find out more

www.bristol.ac.uk/strata

tDCS: Home-based transcranial direct current stimulation (tDCS) treatment for bipolar depression

Who this study is aimed at?

People aged 18 or over who have bipolar disorder with a current depressive episode and are on a stable dosage of mood stabilising medication or are not taking any medications.

Who can't take part?

People who have a neurological disorder, history of seizure, scalp or skin condition.

Study summary 

Researchers want to find out what is the best treatment for each individual with bipolar depression.  They are looking at whether the novel brain stimulation therapy, transcranial direct current stimulation (tDCS), could be a potential treatment for bipolar depression.  Most studies to date have provided tDCS in a clinic.  Researchers would like to study whether tDCS could be provided at home because it is a portable and safe treatment which requires regular sessions for several weeks.

tDCS is a form of brain stimulation.  tDCS produces a small electric current (2 mA) which affects how easily brain cells can discharge.  It does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ECT), and it does not cause brain cells to discharge like transcranial magnetic stimulation (TMS).

Study visits 

Discuss your depression symptoms and any treatments you are currently taking with a researcher who will be able to decide whether you can take part in the study.   

If you are eligible to take part, the treatment is home-based and involves 5 sessions per week for 3 weeks and then 2 sessions per week for another 3 weeks.  Each session is 30 minutes, with a total of 21 sessions.

Researchers will help you learn how to use the tDCS device and a member of the study team will be present at each session via a video link to help you during each session.  

There will also be two pen and paper tasks that researchers will ask you to complete before your first stimulation session and after your final stimulation session.  These tasks take roughly 5 minutes and look at memory and processing speed.

There is also an optional EEG which can be done at home and takes around 10 minutes.  It would be measured before you start the tDCS treatment and after you complete the tDCS treatment.  The EEG device would be sent to your home and works via an app.  A member of the study team would be present via video call to provide training and assistance in setting up and taking the EEG measurement.  EEG is the short form for electroencephalography and it measures which areas of the brain are active at particular time points.

Your participation in this study would be expected to last up to 5 months because the researchers would like to contact you after the treatment to see how you are doing.

In the study, the tDCS treatment will be provided at no cost to you.  You will be reimbursed for the time you spend related to your participation in the study.  When you have completed the study, you will be able to keep the tDCS device if you would like to.  

Services taking part

Various Trust-wide, including:

Recovery North (Northlands)

Recovery South (East Glade)

Who to contact  

Dr Will Gann (will.gann@shsc.nhs.uk)

Thoughts about physical activity: questionnaire study

Who this study is aimed at?

  • Participant is willing and able to give informed consent for participation in the study
  • Any gender, 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).
  • Currently attending NHS adult secondary mental health services.

Who can't take part?

  • Insufficient English language to understand and complete questionnaires

Study summary 

Being physically active can be helpful for physical and mental health. But people with psychosis have told us that doing physical activity can be really challenging. Through speaking to people in detail we have heard that what people think makes a big difference to how active they are. We are therefore trying to understand more about these thoughts and the impact that they have on people. We want to develop four new questionnaires, which will help us to find out more about the types of thoughts people have. Understanding more about these thoughts, and how they relate to our behaviour, will be very helpful in the future so that we can develop better support for people wanting to be more physically active.

Study visits 

You will be invited to complete a pack of thirteen questionnaires which should take between 30 and 45 minutes.  You will either complete a pack called Pack 1 or Pack 2. These might be completed in your local NHS clinic, or at home, but either way the researcher will support you to go through the questionnaires (this might be in person, on the phone, or via video call).

The questionnaires cover: information about you (e.g. your age, gender); your current activity levels; your thoughts about being physically active; and other thoughts, feelings and experiences you may have had. You can complete the pack of questionnaires during one research meeting or you could choose to split them up over several meetings if you prefer. If you decide to split them up, the researcher will liaise with you to arrange an appointment to do this and support you on both occasions.

Services taking part

  • East Glade Centre
  • Limbrick Health Centre
  • Michael Carlisle Centre
  • Northlands Community Health Centre
  • The Longley Centre

Who to contact  

Nikki Holdcroft (nikki.holdcroft@shsc.nhs.uk)

Treatment of Hearing Loss in Cognitive impairment: Does early treatment of hearing loss in people with mild dementia or cognitive impairment delay cognitive decline: A pilot Study

Who this study is aimed at?

Adults aged over 65 with mild cognitive impairment or mild dementia

Who can't take part?

  • Unable / unwilling to attend for follow up
  • Severe or Profound hearing loss (>70dBHL)
  • Sign language users
  • Patients unable to follow instructions in English or lacking capacity for informed consent
  • Patients with health conditions affecting neurological function
  • Patients with significant disability
  • Existing hearing aid users

Study summary 

Memory loss and cognitive decline (such as taking longer to perform mental tasks, or reduced ability to learn or solve problems) are some of the early symptoms of dementia.  Hearing loss has been consistently identified as an easily corrected risk factor for dementia. The commonest cause of hearing loss in older adults is Age-Related Hearing Impairment (ARHI) and the commonest treatment for this is Hearing Aid (HA) provision.

Many people that have memory problems also have hearing problems that may be undiagnosed. Hearing loss has been shown to worsen memory problems. It is thought that if hearing aids are provided, this may slow the rate of development of dementia.

Study visits 

If you're found eligible, the research team will offer you a screening hearing test and if that shows some hearing loss, you will be offered a full formal hearing test. If you are found to have hearing loss, they will provide you with a hearing aid.

Your memory will then be tested in 1 years time at your follow up routine care memory clinic appointment to see what the effect of the hearing aids on your memory is.

Services taking part

The Longley Centre

Who to contact  

Dr Aparna Mordekar: aparna.mordekar@shsc.nhs.uk

Understanding anger and aggression: A questionnaire study

Who this study is aimed at?

  • Identify as male
  • Are aged 16 or older
  • Are in contact with mental health services
  • Have been given a diagnosis of psychosis

Who can't take part?

  • 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

Study summary 

There are lots of reason people might get angry or become aggressive. We want to understand these better so we can support people better and improve treatments to reduce violence. You do not need to have had experiences with anger or violence to take part in this study. All experiences are equally helpful to our research. There are no wrong answers we just want to get your views, whatever they are.

Study visits 

Everyone who takes part will meet with a research assistant to complete a series of questionnaires, which should take around an hour.  These might be completed in person, online, on the phone, or via video call depending on what you prefer. Whatever you choose the researcher will support you to go through the questionnaires.

Services taking part

  • East Glade Centre
  • Forest Close
  • Forest Lodge
  • Limbrick Health Centre
  • Michael Carlisle Centre

Who to contact  

Elissa Thompson (elissa.thompson@shsc.nhs.uk)

Jonathan Mitchell (jonathan.mitchell@shsc.nhs.uk)

By taking part in research you will be helping us to test and develop new treatments and methods of care.

All our studies have been reviewed by the Health Research Authority and are carried out by experts from clinical, research and academic backgrounds.

 

Sponsored studies

MH-CREST (Mental-Health Crisis Realist Evidence SynThesis)

This blog from Helen Gilburt, Fellow in Health Policy at The King’s Fund, talks about this study.

MH-CREST is an NIHR funded study which seeks to understand how community crisis care services for people with mental health problems work, who they work for, and in what circumstances. It is led by a team based in The School of Healthcare at the University of Leeds and sponsored by Sheffield Health and Social Care NHS Foundation Trust. Read more here.

Who is the funder?

NIHR Research for Patient Benefit.

What is the grant award?

£345,310.

Who is involved?

Sheffield Health and Social Care NHS Foundation Trust, University of Leeds and University of Sheffield.

Project start

September 2019.

Project end

October 2021. The results of this study are currently being written up.

 

Exploring the feasibility of implementing a home-based exercise training and compression hosiery intervention in patients with venous ulceration (FISCU II)

Who is the funder?

NIHR Research for Patient Benefit.

What is the grant award?

£290,390.

Who is involved?

Sheffield Health and Social Care NHS Foundation Trust, Sheffield Hallam University, Sheffield Teaching Hospitals NHS Foundation Trust and Nottingham CityCare Partnership CIC.

Project start

July 2019.

Project end

August 2022.

Study summary

Venous leg ulcers (VLUs) affect almost 400,000 UK people over the age of 65. These are triggered by inadequate blood flow through the veins causing pain, mobility restrictions, devastation and social isolation. Each VLU costs up to £7.6K per year to the NHS while annual healthcare costs are up to £900 million.

Compression therapy (usually stockings or bandages) are often used to treat VLUs: although healing rates are good, ulcers often return.  Moreover, many remain open for up to 1 year, needing about 50 visits to heal. Consequently, supportive therapies to compression are needed to reduce healing times.

Exercise may provide an answer. We recently completed a small study, examining if it was possible to use a 12-week, community-based exercise programme, along with compression therapy, to treat VLUs. We showed that the programme was safe, participants enjoyed it and were attending their sessions, being also happy to complete their assessments.  The programme also offered reduced healing times and cost savings to the NHS of up to £875 per ulcer. Nevertheless, the programme didn't seem to be accessible for 40-50% of this group; these receive treatment at home and could otherwise do the exercises. Therefore, before embarking to a full-scale study to explore the clinical benefits and calculate the costs of a wider programme implementation, we need to design and explore the practicality of a home-based exercise programme, which would be offered to those who cannot travel. This is worth trying, as our findings indicate that 74% of house-bound people with VLUs would willingly try it.

Our 2-phase, Sheffield-based study will last 36 months. In phase 1, people with VLUs will help us design the home-based exercise programme via round-table discussions, interviews and a workshop. In phase 2, we will recruit 40 people with VLUs, who have treatment at home and although cannot travel, can do some flexibility, stretching and chair-aerobics exercises. Following assessments (measuring ulcer sizes, fitness, quality of life and associated costs among others), participants will be placed into one-of-two groups by a computer: one group will follow the phase 1-defined, home-based exercise programme and have standard at-home compression therapy; the other will receive compression therapy only. All participants will complete 3 home-based assessment sessions: initially at recruitment, then at the intervention end and finally 6 months after group allocation. We will also talk to 18 participants and 10 healthcare professionals, to hear about their intervention experience.

People with VLUs have helped us develop this grant application. They will also help us to: i) design the home-based programme, ii) best-manage the study and iii) interpret and publicise our findings. Upon completion, we will move to a full-scale study, which will provide a solution to this costly and devastating health problem.

Neurodegenerative disease (ND) is an umbrella term for a range of conditions which primarily affect the brain neurons. It includes dementias, Parkinson's disease, Prion and Motor neurone diseases, Huntington's disease, spinocerebellar ataxia and Spinal muscular atrophy.  

Almost 20% of those people who receive "at home" treatment for VLUs, live with NDs as well. Our experience suggests that people who live with early-stage NDs are either reluctant to participate or aren't referred to the study, despite the potential clinical benefits, because of their condition.  As we need to better understand and overcome the specific challenges faced by them in following the programme, we will specifically engage with 6-8 people with NDs and their carers to adapt it, in order to support them in being able to follow the programme to completion. People in this special sub-study, which will run in parallel to the main one, will conform to all study inclusion criteria and will help us adapt the programme and its delivery.  They will also follow a 1-month "crash-course" of the adapted programme and at the end will let us know what went well and what didn't. Once completed, this special sub-study will give us an idea as of how to approach and implement, our exercise programme to wider VLU clinical groups, looking after them in the best possible way.

Promoting Smoking Cessation and Preventing Relapse to tobacco use following a smoke free mental health inpatient stay: the SCEPTRE programme

Who is the funder?

NIHR Programme Grant for Applied Research.

What is the grant award?

£2,719,459.

Who is involved?

Sheffield Health and Social Care NHS Foundation Trust, University of York, Greymattaz, Leeds and York Partnership NHS Foundation Trust, Tees, Esk and Wear Valleys NHS Foundation Trust, Bradford District Care NHS Foundation Trust, University of Nottingham, South London and Maudsley NHS Foundation Trust and University College London.

Project start

January 2020.

Project end

January 2026.

Project summary

The proportion of people with mental illness who smoke tobacco is very high compared to the general population. It can reach figures over 70% among those with schizophrenia and in hospitalised patients with severe mental illness - compared to only around 15% in the general population. As people with mental illness are usually heavily addicted to tobacco, smoking causes large amounts of disease and deaths in this group, often from cardiovascular, respiratory illness and cancer. Smoking has been recognised as the single largest cause of health inequalities for people with mental illness. People with mental illness lose up to 20 years of life mainly to the consequences of their smoking. Although mental health patients often want to quit and can do so successfully, smoking is rarely addressed in mental health care. In many mental health settings in England, a historic 'smoking culture', accepting smoking as the norm, can still be found. However, guidance from the National Institute of Health and Care Excellence (NICE) recommends that all mental health care settings become entirely smokefree, and that mental health patients should have access to evidence-based stop smoking treatment. At present mental health Trusts across England are in the process of implementing this guidance.

For many patients, receiving treatment in a smokefree inpatient environment will be a rare experience of abstaining from tobacco in their adult lives. However, no strategies to help maintain or achieve a smokefree lifestyle and avoid relapse after discharge exist. This means that in the vast majority of cases, patients will return to old smoking behaviours within days of discharge. Huge opportunities to promote health and save lives are being missed.

We propose to develop and test ways to support mental health inpatients after discharge in maintaining or achieving abstinence from tobacco smoking, building on existing evidence and new theory-based components. We will interview patients to explore their experiences and support needs relating to smoking that take into account the home and social environment. We will also explore mental health staff attitudes and training needs related to the subject. Complementing existing evidence with our new findings, we will design a multi-component intervention that is based on behaviour change theory and finalise it in workshops with staff and service user/carer representatives. We will then test the intervention package and refine it where necessary. We will conduct a randomised controlled trial, to see whether our intervention is more effective than current practice, and analyse whether our model represents value for money in the long term. If our findings are positive, we will develop a strategy for implementing the intervention in the NHS. An effective and cost-effective support model could help to save lives in this disadvantaged group.

Project website

www.york.ac.uk/healthsciences/research/mental-health/projects/sceptre

Supporting Physical and Activity through Co-production in people with Severe mental illness (SPACES)

Who is the funder?

NIHR Programme Grant for Applied Research.

What is the grant award?

£2,525,160.

Who is involved?

Sheffield Health and Social Care NHS Foundation Trust, University of York, University of Leeds, Sheffield Hallam University, Northumbria University Newcastle, King's College London and University of Sheffield.

Project start

June 2021.

Project end

May 2027.

Project summary

The problem

People with severe mental health problems such as schizophrenia and bipolar disorder often die 15-20 years earlier than those without, and this difference is getting bigger. Most of these early deaths are caused by preventable health problems such as heart and lung disease. One change that can help people to live longer is being more physically active. This can lower the risk of major illnesses; such as stroke and cancer by up to half. Leading health organisations have said that encouraging people to be more active is as important as encouraging stopping smoking. People with mental illness spend more time sitting still than people without mental health problems.

What we will do

We are a group of people with direct experience of mental ill health, working collaboratively with the Universities of York, Sheffield, Sheffield Hallam, Leeds, Kings College London and Northumbria together with the NHS to lower this difference in life expectancy. This study will help us understand the challenges faced by people with mental illness in becoming more active. In this project we will develop and test ways to support people with mental illness to become more active. We will ask people what types of physical activity suit them best, and the difficulties they encounter in moving more. We will then use this to work with NHS staff, service users and carers to develop a physical activity programme to help people become more active and spend less time sitting still. We will test the programme and change it where necessary. Finally, we will conduct a fair test (called a randomised controlled study) between the new physical activity programme and what we have now. This will tell us whether the programme can benefit people who use the NHS.  We will also look at costs to see if the programme is good value for money. This will help people who decide priorities in the NHS to choose whether to invest in physical activity programmes.

Involving the public

People who use mental health services (and people who support them) have worked to develop this proposal, and they will work together throughout the SPACES programme. They will contribute to the running of the project and in designing an acceptable physical activity programme. Service users and carers will be involved in all stages of the project including communication of results to public, healthcare, research and physical activity staff.

Impact

The SPACES programme has the potential to help people with mental ill health to live longer, happier and more equal lives. This could also mean that the NHS does not have to treat long term physical problems, which increasingly consumes a large portion of the small amount of money that it is allocated.

Project website

www.spacesproject.co.uk

Completed study summaries

Lifestyle Health and Wellbeing Survey

People with severe mental ill health currently experience a bigger mortality gap compared to the general population, partially due to preventable physical health conditions linked to health risk behaviours such as smoking and lack of physical activity. This study aimed to benchmark health risk behaviours in people with severe mental ill health by inviting people with a diagnosis of severe mental ill health to take part in a short questionnaire about demographics, health risk behaviours and motivation to change those behaviours. It found that people with severe mental ill health are more likely to smoke than those in the general population and are at risk of not meeting the government guidelines regarding physical activity and fresh fruit and vegetable consumption. However, people are motivated to change these behaviours and it is therefore recommended that interventions are developed to help them do this.

If you wish to find out more information about the network behind this study, click here.

How to improve care for people with severe mental illness and a lung condition

People with a lung condition and severe mental illness can find it difficult to access primary care.

You can find out more about our involvement in this project here.

Co-Producing a physical activity intervention with and for people with severe mental ill health - the SPACES story

SPACES (Supporting Physical Activity through Co-production in people with Severe Mental Illness) is a study which aims to develop an intervention to increase physical activity created with and for people with severe mental ill health (SMI), their carers and professionals involved in physical activity and/or severe mental ill health.  

The SPACES team recently published their findings, the full report can be accessed here: https://tandfonline.com/doi/full/10.1080/2159676X.2022.2161610 

 

 

 

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