Not yet recruitingOBSERVATIONAL

IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD

The IBDminds study aims to understand how mental health, specifically anxiety and depression, influences the effectiveness of advanced treatments for Inflammatory Bowel Disease (IBD). Many people with IBD experience difficult symptoms like tummy pain and extreme tiredness, and these can significantly impact daily life. While advanced treatments can help, their effects sometimes wear off, often for reasons we don't fully understand. We suspect that anxiety, depression, and stress might contribute to this. This study will ask people with IBD who are on certain advanced therapies to complete questionnaires about their mental well-being and then track if their treatment continues to work well. The goal is to see if there's a link between mental health and treatment success in IBD and to share these findings widely.

At a glance

Status

Not yet recruiting

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Enrolment target

450

Start

01 May 2026

Estimated completion

01 May 2028

Inflammatory Bowel Diseases Mental Health Issue

What is this study about?

Living with Inflammatory Bowel Disease (IBD) can be really challenging. Symptoms like frequent diarrhoea, tummy pain, and feeling exhausted all the time are common and can make everyday activities like working, studying, or keeping up with relationships difficult. Because IBD is a lifelong condition, managing these symptoms effectively is crucial. While we have advanced treatments that can help, they unfortunately don't work for everyone, and for some, their effects can wear off over time. In fact, research shows that for about two out of every five people, these treatments become less effective within a year.

We know some reasons why treatments stop working, but there are many more factors we don't yet understand. We believe that feelings of anxiety, depression, and stress might make these advanced treatments less effective. Past research has shown that people with IBD who also experience anxiety, depression, or high stress levels tend to have worse health outcomes overall. This study wants to investigate this further by looking specifically at people who are receiving advanced therapies for their IBD.

To do this, we're asking people with IBD on specific advanced treatments to complete questionnaires about their anxiety, depression, and stress levels. We will then follow them to see if their treatment continues to work well. With the help of people living with IBD, who have shared that their disease often feels worse when their mental health is struggling, we hope this study will provide important answers. The findings will be shared with patients, carers, doctors, and researchers to help improve care for people with IBD.

Key takeaways

Looks at how anxiety and depression might affect IBD treatment.
Focuses on people with IBD receiving specific advanced intravenous therapies.
Involves completing questionnaires about mental well-being.
Aims to understand why IBD treatments sometimes lose effectiveness.
Will share findings to help improve future IBD care.
No changes to your current IBD treatment are required if you participate.

Who may be eligible?

To take part in this study, you need to be aged 16 or over and have a confirmed diagnosis of either ulcerative colitis or Crohn's disease, which are types of Inflammatory Bowel Disease (IBD). You must also be receiving regular intravenous (into a vein) infusions of either infliximab or vedolizumab as a maintenance treatment.

There are a few reasons why you wouldn't be able to join the study. For instance, if you're currently pregnant, or if you're receiving your initial 'loading doses' of the medication (you could join once these are complete). We also can't include you if you're planning to have surgery for your IBD within the next year, if you're thinking about switching to a different advanced treatment soon, or if you're planning a break from your current medication. Additionally, if you have a stoma or are receiving your IBD medication as injections under the skin, this study wouldn't be suitable for you.

Quick self-check

Are you 16 years old or over?
Do you have a diagnosis of Crohn's disease or ulcerative colitis?
Are you currently receiving infliximab or vedolizumab via regular intravenous (into a vein) infusions?
Are you able to provide consent to take part?
Are you NOT pregnant?
Have you completed your initial 'loading doses' of medication?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you won't need to visit a clinic specially for the research. Instead, you'll be asked to complete a set of questionnaires. These questionnaires will ask about your experiences with anxiety, depression, and stress. The researchers will then track how well your existing IBD medication (infliximab or vedolizumab given as regular infusions) is working for you over a period of time. There are no changes to your current medication or treatment plan as part of this study. The exact duration of your participation will depend on how long the researchers follow your treatment response.

Potential risks and benefits

Taking part in this study involves completing questionnaires, which might make you think about aspects of your mental health that could be upsetting for some people, but you can choose not to answer any question you prefer. The potential benefit is that the information you provide will help us understand more about how mental health can affect IBD treatment, potentially leading to better care and support for people with IBD in the future. There are no direct medical benefits to you personally, and you can withdraw from the study at any time without affecting your medical care.

Locations (1)

The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom

Common questions

What is IBD?

IBD stands for Inflammatory Bowel Disease. It's a group of long-term conditions where parts of your gut become inflamed, leading to symptoms like tummy pain, diarrhoea, and extreme tiredness.

What are 'advanced therapies' for IBD?

These are stronger, more targeted medications often used when standard treatments haven't worked well enough to control IBD symptoms. In this study, we're looking at treatments given directly into your vein (intravenous infusions) like infliximab or vedolizumab.

Will taking part change my IBD treatment?

No, this study will not change your current IBD treatment. You will continue to receive your usual care from your medical team.

Who is funding this research?

The information provided doesn't specify the funding body for this research. This detail is usually provided in official study documents.

When will the results be available?

The study aims to publish its findings so that patients, carers, doctors, and researchers can learn from them. The exact timeline for this is not specified but research studies take time to complete and analyse.

How to find out more

Lorraine Jacques

rwh-tr.sponsorshipofresearch@nhs.net 01902 695065 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.