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NOT YET RECRUITING
NCT07175454

IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD

Sponsor: The Royal Wolverhampton Hospitals NHS Trust

View on ClinicalTrials.gov

Summary

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.

Official title: A Study to Describe the Burden of Mental Ill Health in Inflammatory Bowel Disease Patients Using Advanced Therapies, and to Identify Any Associations Between Common Mental Health Problems and the Efficacy of Such Advanced Therapies (IBDmind)

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

OBSERVATIONAL

Enrollment

450

Start Date

2026-05

Completion Date

2028-05

Last Updated

2026-04-09

Healthy Volunteers

Not specified

Interventions

OTHER

Questionnaire

Patients/research nurses will complete questionnaires detailing their medical history including mental health and describing their IBD. Patients will complete baseline scoring questionnaires for depression and anxiety (HADS) and perceived stress (PSS-10). Patients will also complete a patient reported outcome tool to assess their current disease activity level (PRO-2)

Locations (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom