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

The Mind-Body IBD Study: Understanding the Bidirectional Relationship Between Depression and Anxiety With Physical Health Outcomes and Inflammation

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Crohn Colitis
• Intervention / Treatment: Other: Data collection

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Natasha Seaton, MSc; Phone Number: 0207 188 1189; Email: natasha.seaton@kcl.ac.uk
• Study Contact Backup: Name: Natasha Seaton; Phone Number: 0207 188 1189; Email: mindbody-ibd@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • King's College London
    • Contact: Natasha Seaton; Phone Number: 0207 188 1189; Email: natasha.seaton@kcl.ac.uk
    • Contact: Phone Number: 0207 188 1189; Email: mindbody-ibd@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with IBD in the UK, who have experienced a flare within the last 2 years.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Data collection; Participants will answer questionnaires and submit stool samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Weight (in kg) and Height (in m) will be combined to calculate BMI (weight in kg / (height in m)^2	Month 0, Month 6, Month 12
Smoking status	Current smoking status, including amount of cigarettes consumed per day.	Month 0, Month 6, Month 12
Alcohol Consumption	Number of units drunk in the past week.	Month 0, Month 6, Month 12
Physical activity: International Physical Activity Questionnaire	Physical activity. There are three subscales (vigorous activity, moderate activity and lower-level activity). Scores will be in minutes. Higher scores will indicate more physical activity performed.	Month 0, Month 6, Month 12
IBD medication	Current medication and dose.	Month 0, Month 6, Month 12
IBD flares	Frequency and severity (4-point scale) of IBD flares (in last 6 months)	Month 0, Month 6, Month 12
Sleep - the Pittsburgh Sleep Quality Index (PSQI)	Sleep quality in the last month. Min=0, max=21, with higher scores indicating worse sleep quality.	Month 0, Month 6, Month 12
Diet - Healthy Eating Assessment	8-item simplified food frequency questionnaire designed for use in primary care settings. The tool will be adapted so that each item is score 1-5. Mix=8, max=40, with higher scores indicating better diet quality.	Month 0, Month 6, Month 12
IBD quality of life - short Inflammatory Bowel Disease Questionnaire (sIBDQ)	The sIBDQ is a ten-item questionnaire that covers four domains: bowel symptoms, systemic symptoms, emotional health, and social functions. Min=10, max=70, with a lower score indicating lower quality of life.	Month 0, Month 6, Month 12
Medication Adherence - Medication Adherence Report Scale (MARS)	5-item scale on a 5-point scale.Mix=0, Max=20, with higher scores indicating better adherence.	Month 0, Month 6, Month 12

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Medical Research Council
• Investigators: Principal Investigator: Rona Moss-Morris, PhD, King's College London

Publications and helpful links

Helpful Links

• Study information and sign up

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Estimated): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: health; exercise; sleep; psychology; depression; adherence; mental health; anxiety; stress; diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Colitis
• Other Study ID Numbers: 33844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No