What is clinical research?

Clinical research is the study of health and illness in people. This is often split into two groups:

  1. Observational studies

These studies help researchers to understand a situation through observation of a particular area of interest and may take the form of the following types of studies:

  • Surveys / questionnaires
  • Blood / saliva samples

2. Clinical trials

Clinical trials test new ways of preventing, detecting or treating disease or illness. Treatments might be:

  • New drugs or combinations of drugs
  • New surgical procedures
  • New devices
  • New behavioural intervention

Clinical trials can also test other aspects of care, such as ways to improve the quality of life for people with chronic illnesses.

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 the GLAD 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 & Development contacts:

Ali Young (alexandra.young6@nhs.net)

Jo Morris-Bone (jo.morris9@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 & 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 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 & 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 to recruit 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 & Development contact:

awp.ncmh@nhs.net
 

This study aims to understand if some cases of psychosis are caused by immune system problems in some people.

The immune system normally controls our ability to fight infection, but if the immune system goes wrong it may cause diseases called ‘autoimmune’ diseases.

It is possible to diagnose some of these immune diseases using blood tests, and treatments are available if a disease is found.

To be involved in this study you will be asked to give a blood sample.

The appointment may take up to one hour of your time.

You will receive £10 for the time you have spent taking part in the study.

If, from the blood test, we find that you test positive for a disease of the immune system, the study team will contact your clinical team, who, in turn, will contact you with potential treatment options.

To take part in the study you must be:

  • Aged between 18-70 years old
  • Experiencing some symptoms of psychosis

AWP Research & Development contact:

awp.ppip@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 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 & 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 EDGI 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 & 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 & 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 the OCD 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 & Development contact:

awp.kingshillresearch@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 & 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 & Development contact: 

Mashal Asif (mashal.asif1@nhs.net