IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD

NCT07175454 | Not Yet Recruiting DMC

• 1 other identifier: 2025GAS146
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (4)

• Patient Reported Outcome-2 (PRO-2)

  PRO-2 is an established patient reported outcome measure for IBD. There are separate measurement tools for UC and CD. In UC patients report the rectal bleeding sub-score and stool frequency sub-score from the clinical Mayo score. In CD patients report 3 days of the number of liquid or soft stools and severity of abdominal pain. In both UC and CD the score is well validated to Mayo clinical score and CDAI respectively, and to faecal biomarkers.

  Every 4 weeks over the course of a year

• Patient Health Questionnaire-9 (PHQ-9)

  PHQ-9 is a self-administered measure of depressive symptoms over the previous 2 weeks. Questions include 9 domains, asking patients to report the frequency of each. PHQ is-9 is mapped to the DSM-4 diagnosis of major depression and therefore offers robust evidence of depression. Although not specifically designed for physical health problems, validity in this group has been demonstrated. PHQ-9 is also sensitive to change, therefore is well suited to serial measurements.

  Every 4 weeks over the course of a year

• Generalised Anxiety Disorder-7 (GAD-7)

  GAD-7 is a self-administered measure of anxiety over the proceeding 2 weeks. Questions cover 7 domains asking patients to record the frequency of each. GAD-7 is the current UK standard for scale for anxiety utilised in primary care.

  Every 4 weeks over the course of a year

• Perceived Stress Scale (PSS-10)

  PSS-10 is a self-administered measure of symptoms suggestive of stress over the previous 4 weeks. Questions include ;10 domains, asking patients to report the subjective frequency of each. Stress is an important outcome measure as there is a recognised association with active IBD.

  Every 4 weeks over the course of a year

Interventions

Questionnaire OTHER

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)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving IV infliximab or vedolizumab for IBD

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

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Lorraine Jacques

CONTACT

01902 695065; rwh-tr.sponsorshipofresearch@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)