What is clinical research?

Clinical research means the study of people’s health and behaviour. This provides the foundation of healthcare, through making sure that treatments are safe and effective. 

Clinical research can take many forms; however, these can be divided into two main categories:

  1. Interventional studies (or clinical trials)

These studies involve making a change to a treatment and determining the outcome. For example:

  • A new medication 
  • A psychological therapy
  1. Observational studies 

These studies involve improving understanding of a situation without making changes to treatment. For example: 

  • Completing a survey
  • Providing a blood, urine or saliva sample 

Our staff support the delivery of interventional and observational studies within AWP.

We do this to provide our service users, carers and staff with opportunities to take part in research that is relevant to them. 

In this section, you will find a list of all clinical research studies currently being supported by our department.
 

Current clinical research opportunities

Anxiety and Depression

The GLAD Study is a project set up to explore risk factors in individuals who have experienced depression and/or anxiety, including those with a diagnosis of bipolar disorder, OCD, or related disorders, at any time in their lives.

It aims to better understand depression and anxiety in order to find and develop more effective treatments. The GLAD Study is also part of the NIHR BioResource, which is a library of information about people’s health aiming to support research in both physical and mental health.

To take part in this study you must:

  • Have experienced symptoms of anxiety and/or depression during your life
  • Be aged 16 and above
  • Live in the UK

The GLAD Study enrolment process consists of four steps:

  1. Register on the website www.gladstudy.org.uk and read the Information Sheet
  2. Provide consent (please put AWP as where you heard about the study)
  3. Complete a questionnaire
  4. Provide a saliva sample

AWP Research and Development contacts:

Ali Young (alexandra.young6@nhs.net)

Jo Morris-Bone (jo.morris9@nhs.net)
 

 

Clinical depression can impact an individual’s mood and motivation to pursue goals and affects how rewarding they find them. Current first-line treatments, such as psychological therapies and antidepressants, haven’t always proven effective for a good proportion of people who might have Treatment Resistant Depression (TRD).

PAX-D study aims to use an already existing drug called pramipexole (which is currently being used for Parkinson's disease) that could prove effective treatment for TRD by impacting factors such as mood and motivation. 

During the trial, one group of people will be taking pramipexole and the other group will be taking a placebo; a tablet that looks like pramipexole, but has no effect. At the end of the trial, we will compare the information collected on people taking pramipexole with that from people taking placebo.

To take part in this study you must:

  • Be aged 18 or above (male or female)
  • Have a diagnosis of major depression (DSM-V)
  • Be currently taking an antidepressant medication and willing to continue 
  • Haved lacked response to at least two antidepressants at therapeutic doses

Additional information: 

PAX-D study website: https://paxd.web.ox.ac.uk/

AWP Research and Development contacts:

Alexandra Young (alexandra.young6@nhs.net

Mashal Asif (mashal.asif1@nhs.net
 

Autistic Spectrum

We are inviting adults who have a diagnosis of autism and experience anxiety to take part in a research study. The study is called STRATA (SerTRaline for AnxieTy in adults with a diagnosis of Autism). It has been co-produced with experienced clinicians, researchers, and autistic people to investigate the treatment of anxiety in adults with a diagnosis of autism. AWP is hosting this study but people can take part from anywhere in the UK.

You can learn more about what is involved in taking part by reading the participant information here.

Please read the information carefully and feel free to discuss it with family, friends, carers, or others if you wish.

To take part in this study you must:

  • be aged 18 years or over
  • have a diagnosis of autism (including variations such as Asperger syndrome)
  • experience anxiety for which you are willing to try treatment with medication
  • be able to complete online or paper questionnaires about things such as your anxiety, other symptoms, and healthcare usage
  • be able to provide informed consent to take part

How long does it take?

Participants will be enrolled to the study for up to 52 weeks (1 year), during which time they will be asked to take the study medication as directed, and complete four questionnaires (with their time reimbursed with a £10 voucher for each). In addition, there will be five brief safety check appointments to discuss how participants are getting on with the medication and carefully monitor any side effects. All study appointments can be done via video or phone call, or in person appointments (any travel expenses reimbursed) can be arranged according to participant preference.

What could I do next?

If you are interested in taking part in the study, please complete the online expression of interest form here

Alternatively, if you have any questions or would like further information or assistance, please contact the STRATA team by email: strata-takepart@bristol.ac.uk or phone: 0117 428 3001.

AWP Research and Development contact:

awp.strata-rct-secure@nhs.net
 

ADEPT-2 is a Randomised Control Trial (RCT) for autistic adults, comparing Guided Self-Help with NHS support for depression.

Depression is a common mental health issue, related to lower quality of life. Research indicates that autistic people are more likely to experience depression than non-autistic people. 

Effective treatment for depression includes a talking therapy called low intensity Cognitive Behavioural Therapy (CBT). This form of low intensity therapy is based on supporting the person receiving therapy to work through evidence-based information. This is called Guided Self-Help which has been shown to be useful in non-autistic adults, but it is not known whether it would also be useful for autistic adults.

The main goal of the ADEPT-2 study is to find out whether Guided Self-Help is helpful in reducing depression experienced by autistic adults. 

The ADEPT-2 study also aims to determine whether Guided Self-Help would have a good cost-benefit for the NHS. In addition, the ADEPT-2 study aims to find out whether Guided Self-Help received by an autistic adult has impact on their family carers or supporters. 

To take part in this study you must:

  • Be aged 18 and over
  • Have received a diagnosis of autism spectrum disorder from a healthcare professional(s)
  • Experience low mood or depression
  • Be able to complete forms with questions either online or on paper
  • Be able to give informed consent to take part 

Additional information:

If you decide to take part in the study, you will be randomly selected to receive either Guided Self-Help or NHS support for depression. 

Guided Self-Help involves using a booklet, as well as attending 9 individual meetings with a coach to support use of the booklet. These meetings will be online. If you prefer to meet in person, the study team would be happy to discuss whether that would be possible.   

NHS support for depression might include talking therapy, medication, self-coping strategies, and access to support groups. 

The study will last for 52 weeks. Taking part will involve completing questionnaires at the start of the study, as well as 16 weeks, 32 weeks and 52 weeks later. You will be able to claim a £10 gift voucher for completing every set of questionnaires in the study. There will also be the option to be interviewed about your experience of the study at the end of the study. 

Further information about the ADEPT-2 study can be found here.

ADEPT-2 study team contact:

If you wish to discuss the ADEPT-2 study or reasonable adjustments for taking part in the study, you can contact the ADEPT-2 study team directly by telephone (07855 973171) or email (adept-takepart@bristol.ac.uk)

AWP Research and Development contact:

awp.adept-2@nhs.net

Bipolar and Psychosis 

We are trying to understand why some people experience problems with their mental health. The purpose of this study is to collect information and samples for genetic, biological, psychological and clinical research. This will allow us to look for genes and other factors which make some people more likely than others to become ill.

We hope the study will improve understanding of these conditions and help find better treatments in the future.

We are looking for service users to take part from: 

Early Intervention Services:

  • Over 16-years-old 
  • Lived experience of psychosis

Mother & Baby Unit:

  • Over 18-years-old

With each participant we hope to complete a basic assessment (demographic information, details about the participant’s personal and family history of neurodevelopmental and neuropsychiatric disorders, and questions about medications, physical illness and lifestyle) and take a blood/saliva sample (if possible).

AWP Research and Development contact:

awp.ncmh@nhs.net
 

The University of Manchester are conducting a research study to understand staff and service user views about using digital devices, such as a smartphone or wearable device, to help manage mental health. 

The study team would like to understand service user opinions of this topic, as well as how people use digital devices. 

The study will aim to survey at least 300 people with lived-experience of psychosis. The study team would like those taking part in the survey to have a wide range of experience using technology. This includes people that already use a smartphone or wearable device, and those that do not. 

To take part in this study you must:

  • Be aged 18 or above
  • Have a diagnosis or have treatment for psychosis, schizophrenia, or unusual distressing experiences (e.g. hearing voices or having usual beliefs)
  • Be able to understand and speak English

Additional information: 

You will be asked some questions about your age, mental health and use of mental health services to confirm you can take part in the study. 

If you are able to take part, you will be asked to complete a survey; either online or using a paper copy. This survey will ask about your views of digital devices, as well as how these can be used in mental healthcare. 

The survey should take 20-30 minutes to complete. Survey responses are anonymous and there will be no way to identify the people that take part. 

By taking part in this survey, you service users are eligible to be entered into a prize draw to win £50 (as vouchers, cash, or bank payment). 

To read the participant information sheet and take part in the study, please click here

AWP Research and Development contacts:

Harry Walker (harry.walker@nhs.net

Joanna Morris-Bone (jo.morris9@nhs.net
 

Dementia

Evoke is a three-year study looking at the effect and safety of a daily tablet called Semaglutide, which is already licensed to help control type 2 diabetes. The study is ‘double blind’, which means that both the subjects taking part in the trial and the people studying them do not know who is taking the real drug or a placebo. The study is being trialled around the world.

Taking part would involve visiting Kingshill Research Centre (Swindon) for assessment on 17 occasions, as well as being available for an additional single phone call over approximately a three year and three month study period.

To take part in this study you must:

  • Be 55-85 years old at the point of signing informed consent to take part in the study
  • Have Mild Cognitive Impairment (MCI) or mild dementia of the Alzheimer's type (according to the NIA-AA 2018 criteria)

You will not be able to take part if:

  • You demonstrate evidence of a relevant neurological disorder other than MCI or mild dementia of the Alzheimer's type at the point of screening (an assessment before taking part)

AWP Research and Development contact:

awp.kingshillresearch@nhs.net

Eating Disorders

EDGI is a project set up to explore risk factors in individuals who have experienced eating disorders, including anorexia nervosa, bulimia nervosa, binge-eating disorder or any other eating disorder at any time in their lives.

It aims to better understand the genetic and environmental links to eating disorders in order to improve treatments for current and future patients. EDGI is also part of the NIHR BioResource, which is a library of information about people’s health aiming to support research in both physical and mental health.

To take part in this study you must:

  • Be aged 16 and above
  • Live in England
  • Be currently experiencing or have experienced an eating disorder

The EGDI study enrolment process consists of four steps:

  1. Registering on the website edgiuk.org and reading the information sheet
  2. Providing consent using the online form (please put AWP as where you heard about the study)
  3. Completing a questionnaire
  4. Providing a saliva sample

AWP Research and Development contact:

awp.edgi@nhs.net
 

 

Improving Access to Psychological Therapies (IAPT)

This study aims to determine what predicts the outcomes of psychological treatment offered to adults with common mental health problems that access Improving Access to Psychological Therapies (IAPT) services. This study also aims to understand whether psychological treatment outcomes differ between working age (18-64 years-old) and older (65+ years-old) adults accessing IAPT services. 

Taking part in this study would involve the completion of an online questionnaire at the start of receiving step 2 or step 3 treatment through IAPT services. 

To take part in this study you must:

  • Be over 18 years-old
  • Have an offer to receive step two or step three treatment through an AWP IAPT service for a depression and/or anxiety disorder
  • Read and understand English at the required level to respond to the participant information sheet for the study and answer the online questionnaire 

AWP Research and Development contact:

Mashal Asif (mashal.asif1@nhs.net)

Obsessive Compulsive Disorder (OCD)

This study is a Randomized Controlled Trial (RCT) of Troriluzole, alongside anti-depressant treatment for Obsessive Compulsive Disorder (OCD).  

The main goal is to understand the effects of Troriluzole on OCD symptoms.

Troriluzole has been considered to show benefit for people affected by the symptoms of OCD (an investigational drug for OCD at this point). 

People affected by the symptoms of OCD have been shown to have high levels of Glutamate. Troriluzole might be beneficial in reducing these levels of Glutamate, which cause OCD.

This is a 12-week study.

Those taking part will need to attend Kingshill Research Centre (Swindon) on seven occasions throughout the study period. 

Visits to Kingshill Research Centre will involve the following:

  • Physical health observations and assessments 
  • Questionnaire-based assessment measures

To take part in this study you must:

  • Be 18-65 years-old
  • Diagnosed or had symptoms of OCD for a year
  • Be currently taking Selective Serotonin Reuptake Inhibitors (SSRIs) for an adequate duration and dose, but with little beneficial response
  • Be able to read, write and understand English in order to consent to take part (those with cognitive impairments will be excluded from taking part)

AWP Research and Development contact:

awp.kingshillresearch@nhs.net

Paranoia

The STOP trial aims to investigate the use of a new treatment for the symptoms of paranoia. The treatment uses a mobile phone App aimed at reducing cognitive bias, meaning the way the brain simplifies information through the filters of personal experience. The trial will test whether the mobile phone App can help replace harmful and distressing paranoid thoughts with better alternatives. 

To take part in this trial you must:

  • Be age 18 or above
  • Have clinically significant paranoid and persecutory symptoms that have continued for at least a month, regardless of diagnosis
  • Have been stable on psychotropic medication for a minimum of 3 months
  • Have no major physical illness or substance misuse issues (alcohol or drugs)
  • Have an understanding of written and spoken English
  • Have capacity to consent to take part in the trial

Additional information:

You will be asked to use a mobile phone App once per week for either 6 or 12 weeks. This App can be downloaded onto your own smartphone or a smartphone that can be provided for the trial period.

You will be asked to complete an initial assessment with a researcher at the University of Bath. Following this assessment, the researcher will phone you either weekly or fortnightly for a short conversation. There will be follow-up assessments at 6, 12, 18 and 24 weeks after starting the trial. You can claim £20 for completing each follow-up assessment and a final assessment. 

Taking part in this trial does not affect access to your current treatment. Taking part in this trial is voluntary and anyone can withdraw at any point. 

More information about the STOP trial can be found here

AWP Research and Development contacts:

Darren French (d.french4@nhs.net)

David Rudall (d.rudall@nhs.net)
 

Perinatal 

The National Centre for Mental Health (NCMH) is heading an important research study called Maternal Wellbeing, Mental Health and Life Experiences.

This is an online survey that’s looking to understand more about how life experiences and COVID-19 have impacted on maternal wellbeing and mental health during the perinatal period.

We hope the findings will lead to new and improved ways of recognising and providing support in times of need.

The survey can be found here

To take part in this study you must:

  • Be over 18-years-old
  • Be pregnant or have given birth in the last 12 months

Individuals with or without a mental health diagnosis are welcome to complete the survey.  

Participants will also be entered into a prize draw to win up to the value of £100 for their continued participation in the follow up maternal mental health surveys.

AWP Research and Development contacts:

Ali Young (alexandra.young6@nhs.net)  

Jo Morris-Bone (Jo.morris9@nhs.net)
 

Staff (internal and external)

The TOGETHER study is a feasibility Randomised Control Trial (RCT), which involves testing an intervention developed in Australia called 'Groups 4 Health' or 'G4H'. This evidence-based intervention targets social isolation to enhance mental health and well-being.

This study invites a diverse group of practitioners from NHS and non-NHS services who have current service-user facing roles, supporting young people aged 16-25 years-old with current mental health difficulties. 

If you decide to take part, you will first be asked to complete a consent form and then a short online survey. This survey includes questions about yourself, your professional experience, and your attitudes and beliefs about working with young people with mental health problems to support their social relationships and connections. This survey should take 10-20 minutes to complete. 

The TOGETHER study online consent form and survey can be found here.

AWP Research and Development contact: 

Mashal Asif (mashal.asif1@nhs.net

Healthcare represents a stressful profession. There is no single solution to this complex problem, but it has been suggested that mindfulness could help. 

Mindfulness has been described as “awareness that arises by paying attention, on purpose, in the present moment, and non-judgementally” (Kabat-Zinn, 2013). 

The MINDARISE study has been developed to explore NHS staff experiences of practicing informal or formal mindfulness. The study aims to understand the following:

  • How mindfulness practice affects stress, burnout, mental health and well-being over time
  • How mindfulness practice affects self-compassion and compassion for others
  • What helps and gets in the way of mindfulness practice
  • How mindfulness practice is influenced by user perception of the practice

Any experience of mindfulness is useful to the research and could help aid recommendations that influence policy on mental health and well-being support for healthcare staff. 

To take part in this study you must:

  • Be aged 18 and above
  • Be a member of healthcare staff currently employed in a paid/voluntary capacity for the NHS
  • Currently practice or have previously practiced mindfulness either formally or informally
  • Not currently be on long-term sickness absence, as defined as over 4 weeks
  • Have access to email and a computer, smartphone or tablet computer (alternatively be willing to request paper copies of documents by telephone) 

Additional information:

The study will last 6 months. You will be asked to complete a set of questionnaires at the start of study, then again at 3 months and 6 months into the study. The questionnaires can be completed online. The first questionnaire is expected to take 45 minutes to complete and the other two questionnaires should each take 30 minutes to complete. 

If you complete all three online questionnaires in the study, you will be offered the chance to win one of five £50 Amazon gift vouchers.

Between 12 and 20 participants will also be offered an online interview to discuss factors that influence engagement with mindfulness practice. These interviews are optional and will be decided on a first consented, first interviewed basis. 

For more information about the MINDARISE study and to take part, please click here.

Study team contact:

Daniel Cullen (mindarise@sussex.ac.uk)

AWP Research and Development contact:

Joanna Morris-Bone (jo.morris9@nhs.net)
 

The University of Manchester are conducting a research study to understand staff and service user views about using digital devices, such as a smartphone or wearable device, to help manage mental health. 

The study team would like to hear the opinions of healthcare professionals about this topic, as well as how digital health tools could be used in mental healthcare delivery.  

The study will aim to survey at least 300 healthcare professionals who provide care for those with psychosis, schizophrenia or any other mental health problem with psychotic experiences (for example hallucinations or delusions). The study team would like those taking part in the survey to have a wide range of experience using technology. This includes people that already use a smartphone or wearable device, and those that do not. 

To take part in this study, you must:

  • Be aged 18 or above
  • Be a healthcare professional who provides care for individuals diagnosed with psychosis, schizophrenia, or any other mental health issue which includes psychotic experiences (for example hallucinations or delusions)

Additional information: 

You will be asked some questions about your age, occupation, and the service you work in. 

If you are able to take part, you will be asked to complete a survey; either online or using a paper copy. This survey will ask about your views of digital devices, as well as how these can be used in mental healthcare. 

The survey should take 20-30 minutes to complete. Survey responses are anonymous and there will be no way to identify the people that take part. 

By taking part in this survey, you service users are eligible to be entered into a prize draw to win £20 (as a voucher).

To read the participant information sheet and take part in the study, please click here

AWP Research and Development contacts: 

Harry Walker (harry.walker@nhs.net

Joanna Morris-Bone (jo.morris9@nhs.net)