IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorThe Royal Wolverhampton Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients receiving IV infliximab or vedolizumab for IBD
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaire
Other interventionPatients/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)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Every 4 weeks over the course of a year2
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.
Time frame
Every 4 weeks over the course of a year3
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.
Time frame
Every 4 weeks over the course of a year4
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.
Time frame
Every 4 weeks over the course of a yearSponsors and contacts
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Source ClinicalTrials.gov
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