IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD

Starting soon

Conditions studied: Inflammatory Bowel Diseases, Mental Health Issue

In brief

People with Inflammatory bowel disease (IBD) can get challenging symptoms. Things like diarrhoea, tummy pain and being tired all the time are common. People often get IBD in their teens or twenties. They often find working, studying and relationships hard. IBD can't be cured, so it lasts for life. When IBD is hard to treat, we use advanced treatments, but these don't always work. When they do work the effect can wear off. This happens in 2 of 5 people within a year in research studies. There are some things that we know make them wear off. There are lots more reasons that we don't understand yet. We think anxiety, depression and stress make these treatments more likely to wear off. Previous research has suggested that people with IBD do worse if they have anxiety, depression or stress. The investigators want people with IBD to complete questionnaires to see if they are affected by anxiety, depression or stress when they are taking advanced therapies. The investigators will follow those people to see if the effect of their treatment wears off. People living with IBD will contribute to the running and fine tuning of this research. Many of those that have engaged with us so far have said that their disease was worse when their mental health was worse. They were generally supportive of this study to see how anxiety, depression and stress effects IBD in people using advanced therapies. The investigators have talked to a national charity about our work. They will help share the findings so that patients, care givers and other stakeholders will be able to read about them. The results will be published so that doctors and researchers can use them.

Key facts

Study ID

NCT07175454

Run by

The Royal Wolverhampton Hospitals NHS Trust

People needed

450

Starts

2026-05-01

Expected to finish

2028-05-01

Last updated by the study team

2026-04-09

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a confirmed diagnosis of ulcerative colitis, or Crohn's disease, based upon either the outcome of the local multidisciplinary team, clinic documentation or in the opinion of the investigator
• Patients receiving maintenance infliximab or vedolizumab by regular intravenous infusion
• Patients willing and able to give informed consent
• Patients aged 16 or over

You may not qualify if…

• Patients cannot be recruited while receiving their loading dose of infusions, but may be included once complete.
• Patients should not currently be planned for surgery within the next 12 months
• Patients should not currently be planned to switch to another advanced therapy within the next 12 months
• Patients should not currently be planned for a drug holiday within the next 12 months
• Patients should not have a stoma (This would invalidate the PRO-2 outcome measure)
• Patients should not currently be pregnant
• Patient currently receiving subcutaneous infliximab or vedolizumab

Where it is running

• The Royal Wolverhampton NHS Trust — Wolverhampton, United Kingdom

Full record on ClinicalTrials.gov

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