Inflammatory Bowel DiseasesIBDmindsNCT07175454
IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD
An observational study of Inflammatory Bowel Diseases and Mental Health Issue, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Mental Health Issue
- What is being tested?
- Questionnaire
- How many people
- 450 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients receiving IV infliximab or vedolizumab for IBD
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
About this study
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)
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.
Read more
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.
Read the detailed description
The treatment of moderate to severe Inflammatory Bowel Disease (IBD) now consists of a wide selection advanced therapies1. Despite these, the efficacy of advanced therapy has reached a ceiling at approximately 40% of patients achieving remission. Furthermore, a significant proportion will lose response to the medication within 1 year of starting2-4, which is likely to be multi-factorial.
There is a recognised association between IBD and common mental health problems, specifically anxiety, depression and perceived stress, but it is not known whether these impact the effectiveness of IBD treatment.
The bidirectional relationship between mental wellbeing and IBD has been described in a recent meta-analysis5. Patients with anxiety and depression are more likely to develop IBD compared to matched controls without IBD6. This relationship predates IBD presentation by up to 5 years. Therefore, it appears that a complex relationship between IBD and anxiety, depression and perceived stress exists. IBD patients with concurrent anxiety, depression and perceived stress are more likely to have more severe IBD, including; exacerbations, hospital admissions, and need for surgery5.
High levels of perceived personal stress are associated with increased risk of disease exacerbations7. A single study from 2005 demonstrated worse IBD outcomes in patients with severe depression compared to mentally well patients when treated with a single dose of Infliximab (albeit in a practice which is now obsolete). This suggests severe depression is associated with worse outcomes from advanced therapies but further research is needed to validate this association8.
Data to describe a relationship between IBD and anxiety, depression and perceived stress, in patients on advanced therapies is limited. Up to 20% of IBD patients are now progressing to advanced therapies compared to 5% in 20109. Such data is important to consider if intervention for anxiety, depression and perceived stress could improve durability of advanced therapies.
Public contributors to research have articulated that mental health is a key concern. It is a common lived experience amongst patients with IBD that anxiety, depression and perceived stress are a factor in their disease activity. The investigators hypothesise that unrecognised or inadequately managed anxiety, depression and perceived stress is a factor that makes advanced therapies less effective in maintaining remission for IBD patients.
There are also important health inequality considerations. IBD Patients are more likely to develop anxiety and depression if they are from a deprived background, but are also more likely to have worse outcomes from IBD because of anxiety and depression. Worse IBD leads to greater challenge in the workplace and therefore risk of unemployment and increasing deprivation. Research that defines and reduces the negative impact of anxiety and depression on IBD outcomes would also reduce inequality of outcomes driven by deprivation.
The burden of anxiety and depression is increasing10. Current incidence rates amongst any IBD patient using primary care coded data suggest that the incidence of anxiety and depression are 5.5 and 11 per 1000 patient years11. The prevalence of depression at diagnosis has been reported to be 7%6. However, a survey of Australian IBD patients using a combined measure of depression and anxiety found that 50% of patients reported symptoms12. Therefore, the investigators expect a high proportion of patients recruited to this study will report at least some elements of anxiety, depression and perceived stress.
- Conditions
- Inflammatory Bowel Diseases, Mental Health Issue
- Being tested
- Questionnaire
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every 4 weeks over the course of a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startDec 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175454
- Sponsor's protocol ID
- 2025GAS146
- Acronym
- IBDminds
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- IBDminds / 2025GAS146
- Conditions
- Inflammatory Bowel Diseases, Mental Health Issue
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The treatment of moderate to severe Inflammatory Bowel Disease (IBD) now consists of a wide selection advanced therapies1. Despite these, the efficacy of advanced therapy has reached a ceiling at approximately 40% of patients achieving remission. Furthermore, a significant proportion will lose response to the medication within 1 year of starting2-4, which is likely to be multi-factorial.
There is a recognised association between IBD and common mental health problems, specifically anxiety, depression and perceived stress, but it is not known whether these impact the effectiveness of IBD treatment.
The bidirectional relationship between mental wellbeing and IBD has been described in a recent meta-analysis5. Patients with anxiety and depression are more likely to develop IBD compared to matched controls without IBD6. This relationship predates IBD presentation by up to 5 years. Therefore, it appears that a complex relationship between IBD and anxiety, depression and perceived stress exists. IBD patients with concurrent anxiety, depression and perceived stress are more likely to have more severe IBD, including; exacerbations, hospital admissions, and need for surgery5.
High levels of perceived personal stress are associated with increased risk of disease exacerbations7. A single study from 2005 demonstrated worse IBD outcomes in patients with severe depression compared to mentally well patients when treated with a single dose of Infliximab (albeit in a practice which is now obsolete). This suggests severe depression is associated with worse outcomes from advanced therapies but further research is needed to validate this association8.
Data to describe a relationship between IBD and anxiety, depression and perceived stress, in patients on advanced therapies is limited. Up to 20% of IBD patients are now progressing to advanced therapies compared to 5% in 20109. Such data is important to consider if intervention for anxiety, depression and perceived stress could improve durability of advanced therapies.
Public contributors to research have articulated that mental health is a key concern. It is a common lived experience amongst patients with IBD that anxiety, depression and perceived stress are a factor in their disease activity. The investigators hypothesise that unrecognised or inadequately managed anxiety, depression and perceived stress is a factor that makes advanced therapies less effective in maintaining remission for IBD patients.
There are also important health inequality considerations. IBD Patients are more likely to develop anxiety and depression if they are from a deprived background, but are also more likely to have worse outcomes from IBD because of anxiety and depression. Worse IBD leads to greater challenge in the workplace and therefore risk of unemployment and increasing deprivation. Research that defines and reduces the negative impact of anxiety and depression on IBD outcomes would also reduce inequality of outcomes driven by deprivation.
The burden of anxiety and depression is increasing10. Current incidence rates amongst any IBD patient using primary care coded data suggest that the incidence of anxiety and depression are 5.5 and 11 per 1000 patient years11. The prevalence of depression at diagnosis has been reported to be 7%6. However, a survey of Australian IBD patients using a combined measure of depression and anxiety found that 50% of patients reported symptoms12. Therefore, the investigators expect a high proportion of patients recruited to this study will report at least some elements of anxiety, depression and perceived stress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving IV infliximab or vedolizumab for IBD
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients/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) | Other | – |
Primary outcome
Patient Reported Outcome-2 (PRO-2)
Time frame: Every 4 weeks over the course of a year
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.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Every 4 weeks over the course of a year
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.
Generalised Anxiety Disorder-7 (GAD-7)
Time frame: Every 4 weeks over the course of a year
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.
Perceived Stress Scale (PSS-10)
Time frame: Every 4 weeks over the course of a year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Mental Health Issue, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorraine Jacques (01902 695065, rwh-tr.sponsorshipofresearch@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcome-2 (PRO-2) (time frame: Every 4 weeks over the course of a year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.