IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD
Observational · No treatment assigned · 1 site · The Royal Wolverhampton Hospitals NHS Trust
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases and Mental Health Issue. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 16 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 450 participants are expected to take part.
- Start date: 2026-12 (planned).
- Main results expected around 2028-05 (estimate from the record).
- 1 study site listed in United Kingdom.
Main thing being measured
- Patient Reported Outcome-2 (PRO-2) (Every 4 weeks over the course of a year)
In the researchers’ words
People with Inflammatory bowel disease (IBD) can get challenging symptoms. Things like diarrhoea, tummy pain and being tired all the time are common.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Mental Health Issue |
| Lead sponsor | The Royal Wolverhampton Hospitals NHS Trust |
| Enrollment | 450 (estimated) |
| Start date | 2026-12 |
| Primary completion (est.) | 2028-05 |
| First posted | 2025-09-16 |
| Last updated | 2026-09-15 |
| 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) |
| ClinicalTrials.gov ID | NCT07175454 |
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)
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Wolverhampton NHS Trust | Wolverhampton | United Kingdom |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.