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  

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

Elizabeth Veeren: elizabeth.veeren@shsc.nhs.uk

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)

EDGI: Eating Disorders Genetics Initiative

Who this study is aimed at?

Individuals aged 16 or over who:

  • Are currently experiencing or has experienced an eating disorder in the past. Participants with anorexia nervosa, bulimia nervosa, binge eating disorder, or any other eating disorder are welcome to join. A clinical diagnosis is not needed to take part.
  • Have a lifetime of anorexia nervosa, bulimia nervosa, binge-eating disorder, or any other eating disorder defined in DSM-5.
  • Have been diagnosed and/or treated for anorexia nervosa, bulimia nervosa or binge-eating disorder or any other eating disorder defined in DSM-5.
  • Have a probable and undiagnosed eating disorder.
  • Are willing to donate a biological sample (salvia) for genetic analysis.

Who can't take part?

People who don't meet the inclusion criteria. 

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  

If you are interested in the study, you can either contact our team or you can access the study via the link below: Eating Disorders Genetics Initiative | EDGI UK

Jennifer Bingham (jennifer.bingham@shsc.nhs.uk

ORIGIN: Optimising cultural expeRIences for mental health in underrepresented younG people onlINe

Who this study is aimed at?

  • Aged 16-24 years
  • Living in England
  • Currently experiencing or have experienced (over the past year) a mental health problem (for example, feeling very sad or anxious a lot of the time).

Study summary 

Three quarters of mental health problems start before the age of 25. However, people in this age range are the least likely to access and receive mental health care. People from underrepresented backgrounds are even less likely to receive help. For example, people who feel they are not listened to, understood, valued, or miss out on opportunities that others have access to. 

There are lots of long-term consequences if poor mental health goes untreated. Online tools may be a more accessible way of helping people to cope with mental health challenges. In this work, we are looking to develop an online arts and culture experience, to support mental health in diverse people aged 16-24. This would be like an online museum where you could engage with diverse people’s art and artifacts and the stories and lifestyles behind them. At this stage, we would like to learn more about the people whose voices are not well represented in healthcare research to help with this work.

Study visits 

You will then be given the opportunity to fill in a form (online, by phone or in person) where you can answer questions about your age, ethnicity, current mental health, other background information and contact details (email address or telephone number). You may also wish to consider this information and whether you wish to take part, with a supportive adult who you trust. You may also have this person with you when taking part in the study. It should take approximately 10 minutes to complete the questions.

We will select a range of people from different backgrounds, identities and locations for an interview. We will contact you in due course if you are selected for an interview. selected to take part in the interview a researcher will contact you on the telephone number or email address you provided and will invite you to an interview so you can tell us your experiences of mental health and ideas about what might help best. The interviews will take place at a time convenient to you and can be done online through Microsoft Teams, by phone, or in person. We will discuss the time, duration, and format of the conversation with you to ensure that you are comfortable and have the time and space to share your story as you choose. You will be able to take breaks, and we can meet you more than once if you prefer, over several occasions, or within the same day. We are also able to consider other ways of communication if you prefer, as you may have other ways in which you would like to share your experiences.

Services taking part

  • Trust-wide

Who to contact  

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

Routine screening for gambling disorder and gambling-related harm within mental health and drug and alcohol services: A feasibility and pilot study

Who this study is aimed at?

  • Individuals Aged 18 and above. 
  • Presentation at any of the trusts/ sites above for assessment. 
  • Staff members at any of the trusts/ sites above. 
  • Competent and willing to provide informed consent.

Who can't take part?

  • Where the individual has not given explicit consent to take part in the study.
  • Where the individual is deemed not to be competent (e.g., under the influence of substances).
  • Outside of stated age range.

Study summary 

Over half of adults in the UK gamble; but nearly two million of these suffer problems such as debt, relationship troubles, and mental health problems. Most people who experience gambling harms do not ask for help or get sent for treatment. However, people do ask for help from places such as Community and NHS Mental Health Services or Charities such as Humankind. The aim of this research is to find out how many people may be suffering from gambling related harm in mental health and drug and alcohol services in England.

Study visits 

After giving your consent, you will fill in a quick questionnaire (5-10 mins) on a tablet or computer. All your answers will be fully anonymised, so there is no way in recognising who you are. With your permission, we would then like to link the gambling questionnaire to information already collected by this service (which will be made anonymous by the service so you cannot be identified in any way). Your anonymous data will then be shared with us.

Services taking part

  • Trust-wide

Who to contact  

Jade Cupac (jade.cupac@shsc.nhs.uk)

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

Service Configurations for Psychosis

Who this study is aimed at?

  • A person who has had mental health service treatment for psychosis or psychosis-like experiences and do not have a brain disease such as dementia. They may have received a diagnosis of schizophrenia, schizoaffective disorder, nonaffective psychosis, or depression with psychotic features.
  • A family member, close friend or supporter (such as an employer, tutor, counsellor religious advisor or mentor) of someone with these experiences.

Who can't take part?

  • Current distress at a level that would make participation very stressful, or incapacity to consent.

Study summary 

The project has three aims:

  • To understand and produce clear explanations of how people recover when they experience psychosis. We recognise that recovery is different for different people.
  • To produce clear explanations of how services can improve recovery rates and ensure everyone has an equal chance of recovery across different ethnicities.
  • To plan how to change services and apply for further funding to make these changes and see if this helps more people recover.

Study visits 

Taking part in this research involves choosing whether you want to do any of the following things:

  • Attend an in-person creative workshop about recovery (subject to places).
  • Attend further workshops later in the project (information about these is shown below).
  • Be on a list of people willing to have an hour-long interview.
  • Comment on the project using our email list for people interested in the project.
  • Comment on the project by joining our project Facebook page or Instagram page – these are just for people interested in the project.

Services taking part

  • Trust-wide

Who to contact  

Jade Cupac (jade.cupac@shsc.nhs.uk)

VISION-QUEST - Visual hallucinations: A 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 – 65 years of age.
  • Diagnosed with non-affective psychosis (i.e. schizophrenia, schizoaffective disorder, delusional disorder, psychosis not otherwise specified).
  • Currently experiencing visual hallucinations (within the last month).
  • Currently attending NHS adult secondary or tertiary mental health services.

Who can't take part?

  • Insufficient English language to understand and complete questionnaires.
  • Visions as a result of organic disorder or brain injury, or when only under the influence of substances.

Study summary 

One in three people with psychosis experience distressing visual hallucinations (VH) – seeing things that others cannot. When VH occur, they can have a detrimental impact on people’s lives, such as more frequent and prolonged hospital admissions, and greater likelihood of suicide.

This study will conduct the next important steps to improve peoples lives with VH and psychosis. It will develop the first questionnaire of appraisals of VH in psychosis. This will enable people to better assess these and develop the first effective targeted treatments for VH.

Study visits 

Once participants have given informed consent, they will be directed either to paper copies of the questionnaires, an online version of the questionnaire, or questionnaires may be administered over the phone or video call. 

This assessment pack may be completed at outpatient clinics (e.g. community bases), inpatient settings (e.g. in a clinical room on the ward or rehabilitation units), or at home. Participants will complete the questionnaires online, via paper copies, or they may be administered over the phone. Participants will have the option of support from CRN staff either face-to-face or via video or phone consultation. Only video conferencing software that has been approved by the sponsor (CNTW) and the local Trust will be used for clinical contacts (e.g. OneConsultation or Microsoft Teams). Participants will mostly complete the questionnaires in one go, with the option of support of the CRN staff if preferred. If a participant prefers however, they may split the session up so that they complete some measures on one occasion and the remainder on separate occasion(s). The CRN staff will aim to arrange the subsequent sessions at the first appointment but may also contact the participant, if required, via phone, text, email or in writing (according to the participant’s preference) to arrange this. and they will be recompensed £10, or equivalent value in shopping vouchers for their time.

Services taking part

  • Trust-wide

Who to contact  

Jade Cupac (jade.cupac@shsc.nhs.uk)

SPACES full scale RCT: Supporting Physical Activity through Co-production for People with Severe Mental Illness

Who this study is aimed at? 

  • Age: 18 years or over. 
  • Diagnosis of SMI as documented in GP or psychiatric notes.
  • Are able to walk unaided.
  • Are willing to wear an accelerometer.

Who can't take part? 

  • People who lack capacity to participate in the trial as guided by the Mental Capacity Act (2005)
  • Primary diagnosis of drug or alcohol abuse
  • Medical contraindication of physical activity as ascertained by GP or mental health team. 
  • Already physically active (e.g., >300 minutes/week of self-reported MVPA)
  • Non-English speakers 
  • People who took part in the feasibility study

Study summary 

The purpose of this study is to test a programme to increase physical activity. The study has been created with people with bipolar, schizophrenia and schizoaffective disorder, people who support them (carers), and professionals involved in physical activity and severe mental ill health. People with conditions like those mentioned above are generally less physically active than those who don’t have these health conditions, and the World Health Organisation has said that being more physically active can have as big a positive impact on health as stopping smoking.

Study visits 

Once you have given your consent, you will be put into one of two groups (this will be selected at random by a computer and not by a member of the SPACES team). The groups are Physical Activity and Usual Care. If you are in the Physical Activity group, you will receive a physical activity intervention (something designed to help increase physical activity) as well as all of the care you usually receive from the NHS. If you are in the Usual Care group, you will receive all of the care you usually receive from the NHS but will not be asked to complete any of the physical activity intervention.

If you are in the Physical Activity group, you will be asked to answer some questionnaires with a researcher, this meeting may take up to 60 minutes and will be at NHS premises like a hospital or GP surgery, your home or another community location that is convenient for you and the researchers. 

You will be asked to wear a monitor on your wrist to measure your current level of physical activity. We will ask you to do this for 10 days. There will be two similar follow up appointments after 3, 6, and 12 months, lasting up to 45 minutes and you will be offered £20 cash or vouchers at each of these three appointments to thank you for your participation. 

You will also be invited to take part in the SPACES physical activity programme, which is an 18-week activity programme which offers a two-hour group session once a week with up to an hour of activity as well as discussion and reflection or socialising time. The group will be made up of people who live with severe mental ill health and will be guided by two trained Physical Activity Coordinators. The activity within the group sessions will include three activity types that will rotate throughout the 18-week programme.

Services taking part 

Trust-wide 

Who to contact 

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

Alex Carey - alex.carey@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. Research outlined the barriers faced by people with both of these long-term conditions. It suggested that social prescribing could help overcome some of the problems.

This study included people who had both a severe mental health condition (such as psychosis), and a lung condition that causes breathing difficulties (asthma or chronic obstructive pulmonary disease, for example). It found that people with both conditions could be disabled and isolated.

The study concluded that this group of people need support to navigate the healthcare system. Regular contact with the same clinician was helpful. It recommended that social prescribing could help them build support networks.

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.

HOMESIDE: Home-based family caregiver-delivered music and reading interventions for people living with dementia

Dementia is an umbrella term for diseases that lead to a decline in cognitive abilities such as memory and other thinking skills, however dementia also affects behaviour, feelings, and relationships. People living with dementia sometimes experience psychological symptoms like anxiety, apathy, depression, or distress.

In the HOMESIDE study, the study team wanted to find out whether family caregivers could use music and reading activities with the person with dementia they care for to help alleviate these psychological symptoms. They were inspired by the success of professional therapists using music therapy in nursing homes and wanted to know if similar benefits could be achieved at home by family caregivers

The HOMESIDE study primary findings have been published in eClinicalMedicine, which is part of The Lancet Discovery Science. The key findings can be accessed here.

The Prevalence of Social Communication PRoblems in Adult Psychiatric INpaTients

Research Summary

Problems with Social Communication (PSC), including Autism Spectrum Disorders (ASD’s), are lifelong and associated with difficulties in social interaction, communication and restricted, repetitive behaviours. Most research has focused on these issues in childhood. Little is known about how common ASD’s and other PSC are among adults, including those admitted to psychiatric hospitals.

Identifying people with ASD’s and other PSC will enable them to access services appropriate for their needs that can improve their quality of life. There is a risk that these people are otherwise incorrectly diagnosed with other mental disorders, and offered treatments unlikely to be helpful for them. Nevertheless, some people have both PSC or ASD and other mental and physical health conditions (comorbidities), though the extent of this problem is poorly understood.

This study aims to:
(1) Estimate how common ASD’s are amongst adults who have been admitted to psychiatric hospitals
(2) Examine the association between other mental and physical health conditions in this population.

We will collect data on patient’s ASD test scores (on questionnaires designed to identify possible ASD’s and PSC) and physical and mental health (Phase 1). A subgroup of patients, selected via stratified random sampling according to test scores, will be invited into Phase 2, involving comprehensive ASD diagnostic criteria testing and being interviewed about their other mental and physical health conditions. Patients with intellectual disabilities will bypass Phase 1 ASD tests, progressing directly to Phase 2, where they will be also tested with a questionnaire on stigma experiences.

The study’s findings aim to improve understanding of how common ASD’s are among adults admitted to psychiatric hospitals, and the healthcare needs of this group. This will directly benefit patients with ASD, via enabling us to design inpatient services better suited to identifying them in a psychiatric hospital setting and meeting their healthcare needs.

Summary of Results

Adults who had been admitted to acute psychiatric hospitals took part in the study Of the 27 participants without a learning disability who went onto receive an autism diagnostic assessment, 9 (33%) were found to be autistic (4 of these 9 participants had a previous diagnosis of autism prior to taking part in the study). After adjusting for weighting, non-response and outliers, we estimated that 13.7% (95% CI 6.6-20.7) of this patient group are autistic. The autism quotient (a questionnaire used in this study to select for people to undergo diagnostic assessment) demonstrated acceptable-excellent diagnostic accuracy.
Of the 13 participants with a co-occurring learning disability, 7 (53.8%; 95%CI 22.5-85.2) met autism diagnostic criteria on assessment (6 had a prior diagnosis).
After adjusting for the different age and sex distributions of the different groups, cataracts and eyesight problems were significantly more common among autistic participants.* In conclusion, autism is highly prevalent among adults admitted to acute psychiatric hospitals, where autism identification can be improved through routine screening.

*Please note that with respect to the assessment of co-occurring physical and mental health conditions, further analysis has to be conducted as additional Phase 1 data has been since received from other (non-Leicester) sites [i.e. between January to June 2021] (this will not affect the autism prevalence estimate).

More information here

Psychological impact of COVID - 19 - pandemic and experience: An international survey.

Summary of Research
This study aims to explore the psychological impact of COVID-19 outbreak and the resultant restrictions in terms of behavioural, emotional and social factors. Questions will be asked of the data collected to see what factors may be supportive or more detrimental to wellbeing. The general public including health professionals and those with pre-existing mental health conditions will be invited to complete the survey. This will enable identification of vulnerable groups who may experience more extreme or differing impacts to the rest of the population. Additionally the international aspect of the survey will identify any cultural differences, differences caused by the scale of the outbreaks effect across countries and any differences to government responses and restrictions. The questionnaire will be repeated after six months to allow for the development of the epidemic and measure the impact of restrictions being in place for a longer time period. This survey will greatly enhance our currently limited understanding of how such epidemics impact on the populations’ wellbeing. The COVID-19 outbreak is an unprecedented event in modern times and as such its impact cannot be guessed and therefore needs to be measured to inform future service provision and also any future similar circumstances.

Summary of Results
The Psychological Impact of Covid-19 study was an online questionnaire study where people from across the globe were able to volunteer to answer questions about the Covid-19 pandemic, government guidance and their emotional health. The aim was to understand how such natural difficulties affect people’s mental health and wellbeing and help plan for future. So far, the group have published several papers about the results of the study.

The first publication was an early analysis of the first three weeks of data with a focus on healthcare professionals as they were frontline in the fight against Covid. The results showed that Healthcare professionals reported mild depression and anxiety more than non-healthcare professionals. Also, 32% of participants reported suicidal thoughts and those that reported suicidal thoughts before Covid-19 were less likely to communicate with friends or family. It was found that the categories of people most likely to follow Covid government guidelines were being female and increasing age. Those less likely to follow included higher education, homeowners, key worker status, high alcohol, drug use and participants with pre-existing suicidal thoughts.

Rathod, S., Pallikadavath, S., Young, A. H., Graves, L., Rahman, M. M., Brooks, A., ... & Phiri, P. (2020). Psychological impact of COVID-19 pandemic: Protocol and results of first three weeks from an international cross-section survey-focus on health professionals. Journal of Affective Disorders Reports, 1, 100005.

This publication looked at the face covering policy that was in place during Covid-19, when Covid-19 restrictions were relaxed and how this may have affected mental health. The results showed that during the lockdown period and when the lockdown measures were relaxed, reported levels of anxiety and depression were the same, but were more when wearing a face covering was compulsory. The levels of distress caused by Covid-19 decreased when rules were relaxed and even further decreased when the face covering policy was introduced.

Rathod, S., Pallikadavath, S., Graves, E., Rahman, M. M., Brooks, A., Soomro, M. G., ... & Phiri, P. (2021). Impact of lockdown relaxation and implementation of the face-covering policy on mental health: A United Kingdom COVID-19 study. World Journal of Psychiatry, 11(12), 1346.

This paper looked at suicidal thoughts during the Covid-19 pandemic and the times where restrictions were put in place by the government. Results showed that participants who were younger and participants who were male reported having more suicidal thoughts. During the three different time periods that volunteers completed the survey, 31% participants reported experiencing suicidal thoughts in phase 1, 30% in phase 2 and 19% in phase 3.

Rathod, S., Phiri, P., Pallikadavath, S., Graves, E., Brooks, A., Rathod, P., & Lin, S. (2022). The Psychological Impact of COVID-19 Pandemic on Suicidal Thoughts in the United Kingdom. BJPsych Open, 8(S1), S69-S69.

The following papers have been published by colleagues who collaborated from Canada and India Turner, B., Switzer, A., Welch, B., Legg, N., Gregory, M., Phiri, P., Rathod, S., Paterson, T., Psychological mediators of the associations between pandemic-related stressors and suicidal ideation across three periods of the COVID-19 pandemic in Canada, Journal of Affective Disorders, Volume 324, 2023, 566-575, ISSN 0165-0327,

Bhargava, R; Kathiresan, P, Bakhara, Y, Sharma, M. Phiri, P, Rathod, S. Impact of COVID-19 on Mental Health of Aged Population in India: An Online, Cross-sectional Survey. World Social psychiatry, 211-216.2022

Gregory, M.A., Legg, N.K., Senay, Z., Barden, J., Phiri, P., Rathod, S., ... Paterson, T.S.E. (2021). Mental Health and Social Connectedness Across the Adult Lifespan in the Context of the COVID-19 Pandemic. Canadian Journal on Aging / La Revue canadienne du vieillissement 40(4), 554-569. 

More information here

Hearing nasty voices: Developing new ways to measure the experience

Research Summary: Hearing voices is one of the most common symptoms of schizophrenia. We aim to learn why some patients listen to and believe the content of distressing voices. This will enable the later development of psychological therapies which enable patients to disengage from distressing voice content. A crucial step in this process is to develop two questionnaires: i) an assessment of the degree that people listen and believe distressing voices ii) an assessment of the reasons why people listen and believe distressing voices. The items making up each of these questionnaires have come from i) interviews with people who hear distressing voices, ii) a lived experience advisory panel and iii) clinical psychologists with experience of working with people who hear voices. The questionnaires will be tested to check that they measure what we intend them to measure (validity) and are reliable. We will also remove redundant questions which will shorten the questionnaires. To do this we will conduct one study in two part (A&B). Part A will assess the reliability and validity of the two new measures (30-40 minutes). Shortened versions of the questionnaires will be developed and reliability and validity reassessed in a new sample (part B, 30-40 minutes). A sub-sample of participants in part B will complete the new measures (10 minutes) one week later to assess whether the results are stable over time (test-retest reliability). A large number of participants are required to assess validity and reliability. We will therefore recruit participants via the Clinical Research Network (CRN), which has research assistants based in NHS Trusts across the country. The study is funded by the National Institute of Health Research. Participant will be reimbursed £5 for participation. Recruiting via the CRN is a method which has been successfully used by our research group, with no risks identified. Summary of Results: Hearing voices is one of the most common symptoms of a schizophrenia diagnosis, experienced by around 70% of people with this diagnosis. Two thirds of voice hearers experience voices which make derogatory and threatening comments. Our theoretical perspective is that when the patient listens to this negative voice content, and believes the comments to be true, this will exacerbate distress. Our previous work interviewing patients who hear derogatory and threatening voices (DTVs) indicates that there are understandable reasons to listen and believe. This study aimed to develop questionnaires to assess key constructs within this new psychological framework and carry out the first quantitative test of the theory. 38 participating NHS Trusts recruited 591 patients who hear derogatory and threatening voices. They completed item pools to assess the degree of listening to and believing DTVs, and the reasons for doing so. 52% believed the derogatory and threatening comments most or all of the time. Listening was formed of actively listening out for the DTVs and/or passively listening (without any intention). Higher endorsement of listening and believing DTVs predicted higher distress. There were seven groups of reasons for listening and believing: to better understand the threat; being too worn down to resist; to learn something insightful; being alone with time to listen; voices trying to capture attention; voices sounding like real people; and voices sounding like known people. Each type of reason was associated with listening and believing DTVs. Feeling worn down was particularly strongly associated with listening and believing. A framework of listening and believing negative voices has the potential to inform the understanding and psychological treatment of voice distress.

More information here

The end of study report about this can be found here.

Optimising Health and Wellbeing in Social Isolation

Summary of Research 

People with severe mental ill health such as schizophrenia and bipolar disorder experience some of the most profound health inequalities of any sector of society and are at greater risk of being affected by COVID-19 and the pandemic restrictions. There are multiple reasons for this; they are more likely to live in deprived circumstances and are less likely to be digitally connected and therefore may experience difficulties in maintaining social networks and accessing services which have gone online. Furthermore many people with severe mental ill health have long term physical health problems, putting them in a vulnerable group that must isolate for long periods of time. \nThis project is called the Optimizing Wellbeing during Social Isolation (OWLS) study. We will explore how people with severe mental ill health experience the current pandemic restrictions and their social consequences. In particular we will explore the ability of people with SMI to access both primary care and mental health services, whether they are digitally connected and how they utilise digital media and the internet, whether they experience feelings of social isolation and loneliness and finally if they have modified their health-related behavior to reduce the risk of COVID-19. The project is a mixed methods project involving a quantitative survey and qualitative interviews. At the center of the project is a cohort of people with severe mental ill health who have taken part in a previous survey about health related behaviours and who have consented to re-contact. We will use a sampling framework to contact a range of participants from the cohort and invite them to take part in the survey, a sub-section of whom will be invited to take part in a qualitative interview. Data from the OWLS study will be analysed and recommendations made on targeted strategies to mitigate the risk of COVID-19 and the impact of the pandemic restrictions for this vulnerable population. 

Summary of Results 

OWLS summary - review People with severe mental ill health (SMI) experience significant health inequalities compared to people without this diagnosis. There is potential for these inequalities to become more significant as a result of the health risks and restrictions linked to the COVID-19 outbreak. The OWLS study was set up to explore how the pandemic and its associated restrictions have affected people with SMI and suggest ways to mitigate against any widening health inequalities. 367 participants were recruited from a range of demographics within England. Data relating to behaviours known to be harmful to health, showed that whilst some people reported smoking less during the pandemic (12%), over half of the respondents who smoke, were smoking more than before the pandemic (55%). Results from the study show that just under half the people who took part was doing less physical activity than they did prior to the COVID-19 restrictions. Of those who drink alcohol, 29% said that they were drinking more and 27% said that they were drinking less than usual. From the data, the increase in the behaviors mentioned above was associated with being younger and self-reporting of a deterioration in physical health. The increase was not associated with gender, level of deprivation, ethnicity and self-reported deterioration in mental health. During the pandemic, living alone and being younger were associated with being lonely among people with SMI but the same factors were also associated with increased loneliness among the general population. Feelings of social connectivity were associated with living with others. The majority of respondents have Internet access and a device to connect with. Around half of the respondents felt that they had a good to outstanding knowledge of the Internet. There is an important minority (more than 10%) that does not own any digital device or do not have access to the Internet from home. Around a third of all participants expressed interest in learning more about how to use the Internet. Those who were more able to use the Internet were likely to be younger and have bipolar disorder rather than a psychosis-spectrum disorder. Most of the people who said they were using the Internet a lot during the pandemic, also said they felt like their mental health has declined since the beginning of the pandemic. However, it is possible that this is due to the personal characteristics of these people, like for example their diagnosis. The three biggest barriers to Internet use were people not being interested in using the Internet, finding the Internet too difficult to use and security concerns. The most common reasons for using the Internet were, accessing information/ entertainment, staying in touch with friends and buying things other than food. The majority of people reported that they had been able to access both physical and mental health services when they needed to and a face-to-face meeting increased the likelihood that people felt that their needs had been met. Almost a third of people who weren’t currently receiving support from mental health services thought that they would need support in the next year and of those currently receiving support about a quarter thought they would need additional support in the next year. A further quarter of those currently receiving support felt that they might need additional support in the next year. In summary people with SMI will need additional support to prevent worsening of existing health inequalities, support will particularly be needed to help people stop smoking and take more exercise in addition to further support from mental health services. Furthermore support will need to be delivered in a way that works for the individual and not assume that everyone had access to, and can use the internet, or that appointments delivered remotely provide people with the care they need. Recommendations for the future Support people with SMI to enhance their digital skills and increase motivation to use the Internet. Greater support might be needed for older people with psychosis spectrum disorders. The connection between being online and worse mental health warrants greater exploration to understand why this is the case, and to make recommendations about positive use of the Internet. Services should take into consideration individual’s needs, recognizing that needs may fluctuate and allowing patient choice in the mode of delivery and taking into account the digital divide in this population. Plans need to be put in place for increasing funding for services and creating additional low intensity face to face services in addition to what is already available to allow people’s needs to be met as quickly and easily as possible to mitigate against greater longer term consequences, both in terms of physical and mental health. SMI should be recognized along side other sectors of society found to be most adversely affected by the COVID- 19 restriction sand provided with targeted extra support to prevent additional ongoing adversity for one of the most vulnerable sectors of our society.

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A pragmatic, multi-centre, double-blind, placebo controlled randomised trial to assess the safety, clinical and cost effectiveness of mirtazapine or carbamazepine in patients with Alzheimer's Disease (AD) and agitated behaviours.

Research Summary

This study is designed to establish the best treatment for the management of agitation and/or aggression in people with dementia. Agitation and aggression are common in people who suffer from dementia and can cause problems for the patients, families and the people caring for them. There are medicines available to treat agitation, but it is not clear which treatments work best for people with dementia. This study will compare 2 medicines with a placebo (a tablet designed to look like a medicine but that has no active component) to see if either are suitable for treating agitation in dementia. The study is divided into 3 parts: the consent and assessment part is likely take a few weeks; the treatment part will take 12 weeks; and the follow up part will continue to 12 months after treatment starts. Patients will be consented alongside a family or paid carer who is willing and able to consent to provide information for the study and to help the patient take the medication they will be given. Patients will continue to receive care from their doctors and other health and social services in the usual way whilst they are in the trial. The patient will be asked to take 1 tablet for the first 2 weeks of treatment in the trial, 2 tablets in the next 2 weeks and 3 tablets for the remaining 12 week treatment period (unless there are concerns about side effects resulting from them taking the medication). The patient, their carer, their doctors and the research workers will not know whether the patient is taking either of the active medications or the placebo until the end of the trial, although it is possible to find out which medicine they are taking in the event of a medical emergency.

Summary of Results

This is a trial with negative findings but important clinical implications. The data suggests that mirtazapine is not clinically effective (compared to placebo) for clinically significant agitation in dementia. Our findings suggest that there is little reason to recommend the use of mirtazapine for people with dementia who experience agitation. Effective and cost-effective management strategies for agitation in dementia are needed, particularly where non-pharmacological approaches have been unsuccessful, and for people with dementia and their carers living in community settings.

241 participants were recruited and randomised (102 mirtazapine, 102 placebo and 40 carbamazepine) The carbamazepine arm was discontinued in August 2018 due to slow recruitment and the carbamazepine versus placebo analyses were therefore statistically underpowered.
The primary outcome was change in Cohen Mansfield Agitation Inventory (CMAI) at 12 weeks. Mean scores at 12 weeks were not significantly different between participants receiving mirtazapine and placebo (-1.74, 95% CI -7.17 to 3.69, p=0.53). The number of placebo participants with adverse events (65/102 [64%]) was similar to that in the mirtazapine group (67/102, 66%). However, there were more deaths in the mirtazapine group (n=7) by week 16 than in the placebo group (n=1), with post-hoc analysis suggesting this was of marginal statistical significance (p=0.065) and this mortality difference did not persist at 6- and 12-month assessment.
Severity of agitation decreased in both groups at 6 weeks by around 10 CMAI points and continued to be lower than baseline scores at 12 weeks. This change between baseline and 6-week and 12-week outcomes is shown by the separation in 95% confidence limits. At no point was the CMAI difference between the groups statistically significant.

In this study, there were clear decreases in agitation scores overall, with a clinically and statistically significant 10-point drop in the first 6 weeks of treatment, which was then maintained from 6 to 12 weeks; however, this drop was not attributable to mirtazapine because it was also seen in the placebo group. This suggests many cases of agitation will resolve with usual care and without the need for medication.

More information here

Lifestyle Health and Wellbeing Survey: Physical Activity Questionnaire

Summary of Research

Our study will conduct a survey of physical activity behaviours of people with severe mental ill health (SMI) who choose to complete our questionnaire.
The study aim is to provide a benchmark of physical activity behaviours of people with SMI and to try and understand what makes people more likely to take part in physical activity and what prevents people from taking part in physical activity. This survey is being undertaken within the NIHR CLAHRC Yorkshire and Humber Mental Health and Comorbidities Theme.

Summary for Results

This study aimed to understand the attitudes of people with severe mental ill health towards physical activity. Five-hundred and twenty-nine participants completed questionnaires on physical activity patterns, preferences, barriers and motivations. Responses were analysed to explore relationships between individual characteristics and physical activity status. The results suggested that a large proportion of people responding to the questionnaires were insufficiently active and excessively sedentary. Non-compliance with physical activity guidelines was associated with professional inactivity, consumption of fewer than five portions of fruit and vegetables per day, older age, and poor mental health. Participants indicated a preference for low-intensity activities and physical activity that can be done on their own, at their own time and pace, and close to home. The most commonly preferred source of support was social support from family and friends. When asked to identify common motivators to taking part in physical activity, responses favoured improving mental health, physical fitness and energy levels. On the other hand, poor mental and physical health and being too tired were common barriers to taking part in physical activity. The findings of this questionnaire can help to inform physical activity intervention programming for people living with severe mental ill health.
 

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DIAMONDS - Improving diabetes self-management for people with severe mental illness Feasibility Study v1.0

Summary of Research 

People with severe mental illness (SMI) have poorer physical health and a shorter life expectancy by around 20 years compared with the general population. This so-called mortality gap is partly explained by higher rates and poorer management of physical long-term conditions (LTCs) such as diabetes. There may be several reasons for this, including the individual’s mental illness and treatment, challenges to engaging in healthy behaviours, and wider barriers to accessing healthcare and support.

Self-management (eg, taking medications, monitoring symptoms, preventing complications, leading a healthier lifestyle) is an important part of staying well with an LTC. Self-management programmes in the NHS help people with LTCs look after themselves but they often do not address the challenges faced when also managing SMI.

The DIAMONDS research programme aims to overcome this problem by developing a self-management intervention to specifically help people with diabetes and SMI to be healthier. The intervention has been developed in partnership with people with mental illness and diabetes, their family members/friends, and healthcare staff. 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 ability to engage in self-management; limited knowledge and skills for LTC management; and beliefs that LTCs require less managing than mental illness. The DIAMONDS intervention is a 16-week programme that consists of daily self-management tasks, weekly 1-to-1 meetings with a trained facilitator (‘DIAMONDS Coach’) and monthly peer-support group sessions.

In this study (phase 3 of the DIAMONDS programme) we will test whether we can deliver our intervention and explore whether it is acceptable to those people delivering and receiving it. We will also test out our research methods so that we can design a larger study in the future to test whether our intervention works.

Summary of Results:

The aim of this feasibility study was to test the acceptability and feasibility of research processes and intervention delivery in preparation for a randomised controlled trial (RCT).
We successfully recruited 30 participants (adults with serious mental illness and type 2 diabetes) from six NHS mental health trusts in the North of England. Recruitment, consent, and data collection processes were confirmed to be feasible and acceptable to both participants and researchers. Data collection included physical measures (height, weight, waist circumference), blood taking (for measurement of glycated haemoglobin, HbA1c at a central laboratory), questionnaires, as well as measurement of physical activity using a wrist-worn accelerometer (activity tracker) and monitoring of sugar levels using continuous glucose monitors.
 

The DIAMONDS intervention was well received by participants and intervention facilitators (DIAMONDS Coaches). In qualitative interviews we found out that flexibility and participant-centred intervention content were particularly important. We developed methods to assess intervention fidelity (i.e. the extent to which the intervention is delivered as intended) which we will be able to use in the RCT. We also put in place processes to measure health resource use which will be used in the RCT to inform evaluation of cost-effectiveness.
All prespecified objectives and progression criteria were met and the DIAMONDS project will progress to the next stage (RCT). Findings from this feasibility study will directly inform refinements to the intervention and study processes for the RCT.

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Supporting Physical Activity through Co-production in people with Severe Mental Illness: Qualitative Approaches for intervention Development (SPACES:QUAD) (Work Stream 1)

Summary of Research

Life expectancy is reduced by around 15-20 years for people with severe mental illness (SMI) compared to people without SMI, and this gap is increasing. The majority of these early deaths are due to physical health problems, which are partly preventable and which are related to factors including health behaviours such as diet, smoking and physical activity. Increasing physical activity can improve physical health in everyone and The World Health Organization has said that encouraging people to be more active can be as beneficial as quitting smoking. People with SMI are less physically active than the general population. Supporting people with SMI to increase their levels of physical activity could help to reduce the life expectancy gap.

This study will work with people with SMI, their carers’, health professionals and physical activity experts to develop an intervention aimed at helping people with SMI to increase their physical activity and reduce the amount of time they spend sedentary (sitting or lying down).

Participants will be recruited through the NHS and voluntary sector organisations and research with service users, carers and professionals will be carried out in accessible community venues. This study is work-package 1 and will last approximately 18 months. There will be two focus groups, a workshop and interviews (all qualitative research – about thoughts, feelings and experiences rather than numbers/statistics) which will aim to find out about barriers and facilitators to physical activity, create an intervention to increase and do an initial test of acceptability.

This application is for qualitative approaches to physical activity intervention development (funded by the National Institute for Health Research- Programme Grants for Applied Research). Work packages 2-4 involve further testing of the intervention and are not covered here.

Summary of Results

The SPACES:Quad project aimed to design an intervention to support people with severe mental ill health (SMI) to be more physically active.
Over a 12 month period, the research team gathered information from focus groups to a) identify the barriers and facilitators to physical activity for people with SMI and b) identify effective components of already existing physical activity interventions designed for people with SMI.
The focus groups took place in Sheffield and Leeds and were attended by people living with SMI, their carers’ and health professionals who work with people with SMI and/or in physical activity.
The results of this work was presented to our Consensus Group who met face-to-face over a number of months in central Sheffield. This group was made up of people with SMI, carers and health professionals who support people with SMI. Using the evidence collected as well as their own experiences, the Consensus Group were able to input into the production of the SPACES intervention in collaboration with the research team.

The result of this work is the SPACES Physical Activity Intervention, which includes:

  • Weekly group sessions, led by two trained Physical Activity Coordinators (PACs), with up to 60 minutes of physical activity, 30 minutes for a themed discussion on topics surrounding physical activity, and 30 minutes for socialising and addressing any queries.
  • 1-to-1 support between PAC and participant at regular intervals throughout the intervention, including long form consultations (45 to 60 minutes) and brief check-ins (15 to 30 minutes).
  • Weekly session attendance prompts.
  • Peer support from those taking part in the intervention (e.g., participants may choose to create a WhatsApp group to keep in touch outside of weekly sessions).
  • Additional resources such as a participant handbook and a wearable activity monitor.

More information here

The role of Digital Technologies for Health Promotion in Youth Mental Health Settings: A Survey of Service User Perspectives

Summary of Research
There is an increasing amount of investment, research and innovation around using digital technologies in novel ways to improve people’s physical health. However, the extent to which these new digital or “mHealth” solutions are accessible, usable and beneficial for people with mental illness is under-researched. Despite people with mental illness already experience drastic disparities in physical health, having a 2-3 fold risk of cardiovascular diseases and ~15 year reduced life expectancy compared to the general population. Continued efforts towards developing digital health solutions for the general population, while neglecting the needs of those with mental illness, may only serve to increase the extent of these health disparities.
The heightened prevalence of cardiovascular diseases (and resultant premature mortality) associated with mental illness become most evident in older adult, populations. However, physical health risks begin from the onset of mental illness – which, for most people, begins before the age of 25. Preventing cardiovascular and metabolic diseases from arising is more feasible and effective than reversing their long-term consequences. Alongside this, younger people are the prime uses of digital technologies, particularly with regards to smartphones. Therefore, discovering how mHealth interventions can be applied to improve physical health and lifestyles in young people with mental illness could present a novel approach for reducing the health risks faced by this group.
However, there is currently a dearth of research in this area. Thus, this survey study is designed to gain some initial insights into the potential of mHealth approaches towards physical health promotion in youth mental health. In particular, the research will examine if/how young people with mental illness currently use mHealth or ‘apps’ for physical health, what their preferred uses of such technologies would be, and their perspectives on ideal components / features of mHealth interventions for improving their lifestyle and physical well-being.

Summary of Results
The study investigated the views of young adults with mental illness on the use of digital technologies, particularly mobile health (mHealth) tools, for promoting physical health. An online survey was conducted withyoung adults aged 16-30, who were diagnosed with mental illnesses and were receiving mental healthcare. In the online survey study, 746 participants completed the initial screening phase in order to gain access to the full survey. Of those, 424 completed it full, and 200 completed it partially. Of the participants, 40% were female and 90.0% were white British. The participants age ranged from 16 to 30 years old, with the average age 24. The majority of patients had a diagnosis of Depression and/or anxiety.
Full analyses of the survey data are still underway, although preliminary examination has indicated that the majority of participants were in favor of digital health technologies for promoting physical health and related behaviors. Features such as health tracking, health coaching, and peer-support were deemed particularly useful.
Almost all participants owned a smartphone or tablet, with iPhones being the most common. Over half of the respondents used apps related to mindfulness or physical activity/exercise, while others used apps for sleep, weight loss and diet. Most found these apps useful, and around a third used them daily.
The study underscores the potential of mHealth in addressing physical health disparities among young people with mental illnesses. By understanding their preferences, more tailored interventions can be designed to promote physical health and prevent cardiometabolic comorbidities. Further research is needed to develop and implement effective digital interventions in mental healthcare settings.

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A mixed methods study using co-production to explore food insecurity in adults with Severe Mental Illness living in Northern England.

Background to the research

In the UK, it is estimated that 38% of people using food banks have a mental illness. Not having adequate access to healthy food, sometimes referred to as food insecurity, can lead to a range of additional health problems. Levels of food insecurity are higher in Northern England. There is a lack of research, however, on the experiences of people with Severe Mental Illness (SMI) around food insecurity.

Aim(s) of the research

We would like to understand the experiences of food insecurity for adults living with SMI in Northern England. We would also like to find out how we can support people living with SMI to access healthy, affordable food.

Design and methods used

We will work with people living with SMI, a charity, the NHS, and universities. We will employ and train two Peer Researchers (people living with SMI) to help us design an online survey and undertake interviews with people who have SMI. The interviews will ask about how services can be adapted or initiated to help people access healthy, affordable food.

Patient and public involvement

This research came from speaking to service users and they have been involved in writing this application. They told us that they would rather talk about food insecurity to someone with SMI than a researcher. Two people living with SMI will help us with the survey and interviews. Two others will be part of the steering group.

Dissemination

We will use the results to recommend the best way to support people with SMI to access enough healthy food. We will communicate and raise awareness of this research to people working in mental health services and organisations supporting people with SMI. We plan to do more research into new approaches to overcoming food insecurity for those living with SMI.

Summary of results:

What do we know already about the subject?

Food insecurity means that a person doesn’t have enough money to make sure they always have enough food to meet their dietary, nutritional, and social needs.

Food insecurity can lead to a range of additional health problems.

People living with a mental illness are more likely to experience food insecurity than people without mental illness.

What did this study involve?

We carried out a survey of 135 adults with Severe Mental Illness (Schizophrenia, Bipolar Disorder, Schizoaffective Disorder or Psychosis) living in Northern England.

We asked about their experiences of food insecurity.

Peer Researchers (who were people with Severe Mental Illness themselves) then carried out 13 individual interviews asking people about their experiences of food insecurity and how to improve this.

Researchers looked at the results and made recommendations based on these.

What the paper adds to existing knowledge?

Just over half of adults with Severe Mental Illness in this study had food insecurity (50.4%).

There were no differences in food insecurity by age, gender, mental health diagnosis or household income.

There were differences in food insecurity based on location, mental health diagnosis, and number of children in a household.

People with Severe Mental Illness told us that food insecurity is a long-standing issue. They told us about the impact of unemployment, the cost-of-living crisis and fuel poverty on food insecurity. They also described the difficulties they had using food banks such as transport, stigma, and the poor selection of food available.

What does this mean in practice?

Future research should look at actions that can be done to improve food insecurity for people with Severe Mental Illness.

Barriers to healthy food access should be looked into. This might include taking food parcels to people's homes, better quality food in food banks, and tacking the stigma surrounding food banks.
The causes of food insecurity should also be considered.

More information here

Evaluating the impact of minimum unit pricing in Scotland on harmful drinkers

Information on the results of this study can be found here.

Randomised, double-blind, placebo-controlled trial evaluating the effects of naltrexone hydrochloride nasal spray on alcohol consumption in Alcohol Use Disorder

In England, there are an estimated 589,101 dependent drinkers (2016/17), of whom 81.7% are not accessing treatment (Public Health England, 2017). Alcohol misuse is the biggest risk factor for death, ill-health and disability among 15-49 year-olds in the UK, and the fifth biggest risk factor across all ages (Public Health England, 2016). Naltrexone is a drug used to manage alcohol use disorder and has been shown to reduce alcohol consumption in clinical studies. Currently, it can be taken as a daily tablet or given as an injection lasting 4 weeks. If taken as a nasal spray, it is expected to work faster and therefore could be used ‘as needed’ to help reduce cravings for alcohol.

Summary of research can be found here

More information can be found here

A clinical study report synopsis can be found here

Complex mental health difficulties: Learning from the UNSEEN study with recommendations for GPs

Complex mental health difficulties is a transdiagnostic term used to describe patients with mental ill-health who experience repeated episodes of anxiety and depression, with long-term, frequently unpredictable, changes in mood and difficulties in relationships. These patients often fall between services such as IAPT/Talking Therapies and specialist secondary care mental health teams. The care of patients with complex mental health difficulties represents one of the biggest challenges for general practice and the wider healthcare system. The UNSEEN study (Understanding services for people with Complex Mental Health Difficulties) was a two year research study conducted to examine how general practice can better identify people with complex mental health difficulties and provide high quality care. We carried out interviews with patients and GPs and conducted a database study looking for features within electronic healthcare records which might help us identify patients with complex mental health difficulties. In this document we describe what was learnt from UNSEEN and how this might be helpful for GPs in their day to day practice. Complex mental health difficulties include conditions such as personality disorders, dysthymia and complex PTSD. However, rates of coding in electronic health records or formal diagnosis of these conditions are much lower than the actual prevalence rates and therefore many patients go under-recognised. Following the UNSEEN study, we found 7 key areas to think about when considering complex mental health difficulties: (i) early life and antecedents; (ii) emotional regulation difficulties; (iii) social adversity and vulnerabilities; (iv) overlapping mental health-related problems; (iv) comorbid drug and alcohol use/dependence; (v) patterns of prescribing; and (vii) service use patterns. In interviews, GPs recognised this group of patients and highlighted the significant workload and management challenges. GPs expressed frustrations with services and being left holding patients but also described positive experiences of working with newer primary care transformation teams. Continuity of care, allowing time and space for patients, and promoting an empathic culture within the wider practice team were all considered important. Patients with lived experience of complex mental health difficulties described their experiences of trauma and adverse childhood experiences being central to how they made sense of their diagnoses. Their experiences of trying to obtain help from their GP mirrored what we heard in clinician interviews. The challenges experienced on both sides often result in GPs and patients being left frustrated with unsatisfactory consultations and a perception of little progress despite significant efforts. It can be easy to overlook the importance of good general practice in such situations. However, patients in UNSEEN expressed a great deal of positivity towards their relationships with their GPs despite the difficulties experienced. Bringing together what we have learned from UNSEEN, we provide some suggestions to be in consultations. Ultimately, every patient will be different and have their own story and challenges, but we hope that this document will raise awareness and provide a few practical tips in managing complex mental health difficulties.

A clinical study report synopsis can be found here

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