The Mind-Body IBD Study: Understanding the Mind-body Connection in IBD

King's College London

Status: Enrolling

Conditions: Crohn Colitis; Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: Data collection

Study type: Observational

Funder types: Other

Identifiers

NCT06116331

33844

Details and patient eligibility

About

An aspect of IBD care that is often overlooked is mental health treatment. Common mental health problems, such as anxiety and depression are very common in IBD, with a meta-analysis estimating prevalence as high as 25.2% for depression and 32.1% for anxiety. The prevalence of anxiety and depression increases when individuals with active disease are considered, with rates as high as 57.6% for anxiety and 38.9% for depression. Comorbid depression and anxiety in IBD is associated with greater symptom severity, even when statistically controlling for disease activity; more frequent and expensive emergency department visits and inpatient stays, higher costs relating to IBD-related surgery, medication and personal expenditure; noncompliance with medical treatment and finally, increased likelihood of experiencing flares.

However, very few studies attempt to unpick the precise mechanism of these bidirectional relationships.

Indeed, depression and anxiety may have direct effects on physical health through inflammatory or psychoneuroimmunological pathways. Very few studies investigate the longitudinal brain-gut relationship with regards to objective measures of inflammation. Additionally, the indirect effects of mental health are often overlooked. Depression and anxiety are routinely associated with health behaviours, such as diet, physical activity, sleep, and tobacco/alcohol use.These health behaviours are important factors, given their impact on physical health outcomes. Therefore, a thorough investigation is required to ascertain the precise mechanisms that underpin the bidirectional relationship between depression/anxiety and inflammation/physical health, as this will enable practitioners and researchers to establish non-invasive, behavioural treatment targets for this patient group.

AIM The broad aim of this project is to explore whether anxiety/depression has a direct or indirect (via health behaviours) on i) inflammation levels ii) clinical activity and iii) healthcare usage at follow-up, in a population of IBD patients. A secondary aim of the project will be to explore whether changes in disease activity, as measured by self-report measures and faecal calprotectin, explains changes in anxiety and depression symptoms at follow up.

Full description

Participants will be asked to answer online questionnaires at 3 time points, 6 months apart. They will also be asked to do an at-home stool sample test at the first two time points.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Self-reported diagnosis of IBD (pseudo-confirmed with participant's self-reported IBD medication or medication history)
2. Willing and able to give informed consent and participate in the study
3. Aged 18 and over
4. Sufficient command of written and spoken English to understand study procedures and documents, and complete self-report questionnaires
5. UK resident (GP registered)
6. Email address, telephone number and postal address to enable all study procedures
7. Experience at least one flare (requiring medical escalation or medication change) within the last two years

Exclusion criteria

1. Under 18 years
2. Lives outside of the UK
3. Insufficient command of English to understand study documents and procedures
4. Not able to give informed consent Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) in the last two weeks.
5. People with a cancer diagnosis

Trial design

170 participants in 1 patient group

Participants

Description:

Participants will complete 3 online questionnaires at 6 month intervals. At the first two time points they will also be asked to submit 2 at home stool sample tests, to assess fecal calprotectin.

Treatment:

Other: Data collection