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Life sciences · Observational Study
ClinicalTrials.gov · September 15, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07175454). This is a study registration, not published results. Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 450 participants (ESTIMATED). Conditions: Inflammatory Bowel Diseases, Mental Health Issue. Interventions: OTHER: Questionnaire. Primary outcome measures: Patient Reported Outcome-2 (PRO-2) , Every 4 weeks over the course of a year; Patient Health Questionnaire-9 (PHQ-9) , Every 4 weeks over the course of a year; Generalised Anxiety Disorder-7 (GAD-7) , Every 4 weeks over the course of a year; Perceived Stress Scale (PSS-10) , Every 4 weeks over the course of a year. Brief 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.