The Mind-Body IBD Study: Understanding the Mind-body Connection in IBD
1 other identifier
observational
170
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 3, 2023
October 1, 2023
1.7 years
October 25, 2023
November 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
The PHQ-ADS is a composite measure of the Generalised Anxiety Disorder questionnaire (GAD-7) and the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.
Month 0, Month 6, Month 12
Depression: Patient Health Questionnaire - (PHQ-9)
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression.
Month 0, Month 6, Month 12
Anxiety: Generalised Anxiety Disorder scale (GAD-7)
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
Month 0, Month 6, Month 12
Fecal Calprotectin
Measure of intestinal inflammation, higher levels indicate greater inflammation.
Month 0, Month 6
Health service use
4 service use items (GP, psychologist, emergency care, secondary care service) from the client service receipt inventory (CSRI) will be used. Frequency and duration of particular services will be recorded, from which a total time will be calculated. There is no maximum value. Higher scores indicate more health service time used.
Month 0, Month 6, Month 12
IBD activity
For Crohn's Disease patients: The Patient-Reported Outcomes for the Assessment of Crohn's Disease Activity (PRO-CD). The scale contains two sub-scales: 1) bowel signs and symptoms, 2) functional symptoms. Each scale is scored separately. There is no total score for the PRO-CD. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms. For Ulcerative Colitis / unclassified patients: The Patient-Reported Outcomes for Assessment of Ulcerative Colitis (PRO-UC). The scale has 9-items and includes two scales: 1) Bowel signs/symptoms and 2) functional symptoms. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms.
Month 0, Month 6, Month 12
Secondary Outcomes (10)
Body Mass Index
Month 0, Month 6, Month 12
Smoking status
Month 0, Month 6, Month 12
Alcohol Consumption
Month 0, Month 6, Month 12
Physical activity: International Physical Activity Questionnaire
Month 0, Month 6, Month 12
IBD medication
Month 0, Month 6, Month 12
- +5 more secondary outcomes
Study Arms (1)
Participants
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.
Interventions
Eligibility Criteria
Adults with IBD in the UK, who have experienced a flare within the last 2 years.
You may qualify if:
- Self-reported diagnosis of IBD (pseudo-confirmed with participant's self-reported IBD medication or medication history)
- Willing and able to give informed consent and participate in the study
- Aged 18 and over
- Sufficient command of written and spoken English to understand study procedures and documents, and complete self-report questionnaires
- UK resident (GP registered)
- Email address, telephone number and postal address to enable all study procedures
- Experience at least one flare (requiring medical escalation or medication change) within the last two years
You may not qualify if:
- Under 18 years
- Lives outside of the UK
- Insufficient command of English to understand study documents and procedures
- Not able to give informed consent Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) in the last two weeks.
- People with a cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- Medical Research Councilcollaborator
Study Sites (1)
King's College London
London, SE1 9RT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rona Moss-Morris, PhD
King's College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2023
First Posted
November 3, 2023
Study Start
April 1, 2023
Primary Completion
December 1, 2024
Study Completion
December 31, 2024
Last Updated
November 3, 2023
Record last verified: 2023-10