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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116331
• Other study ID #: 33844
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: King's College London
• Contact: Natasha Seaton, MSc
• Phone: 0207 188 1189
• Email: natasha.seaton[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Crohn Colitis
• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Other:
• Data collection
Participants will answer questionnaires and submit stool samples.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Fecal Calprotectin	Measure of intestinal inflammation, higher levels indicate greater inflammation.	Month 0, Month 6
Primary	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
Primary	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	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
Secondary	Smoking status	Current smoking status, including amount of cigarettes consumed per day.	Month 0, Month 6, Month 12
Secondary	Alcohol Consumption	Number of units drunk in the past week.	Month 0, Month 6, Month 12
Secondary	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
Secondary	IBD medication	Current medication and dose.	Month 0, Month 6, Month 12
Secondary	IBD flares	Frequency and severity (4-point scale) of IBD flares (in last 6 months)	Month 0, Month 6, Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study information and sign up