Clinical trial NCT06116331: The Mind-Body IBD Study: Understanding the Mind-body Connection in IBD
Official title: The Mind-Body IBD Study: Understanding the Bidirectional Relationship Between Depression and Anxiety With Physical Health Outcomes and Inflammation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Crohn Colitis
Keywords: mental health
depression
anxiety
psychology
health
exercise
stress
diet
sleep
adherence
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2023-11-03
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with IBD in the UK, who have experienced a flare within the last 2 years.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: Month 0, Month 6, Month 12
measure: Depression: Patient Health Questionnaire - (PHQ-9)
timeFrame: Month 0, Month 6, Month 12
measure: Anxiety: Generalised Anxiety Disorder scale (GAD-7)
timeFrame: Month 0, Month 6, Month 12
measure: Fecal Calprotectin
timeFrame: Month 0, Month 6
measure: Health service use
timeFrame: Month 0, Month 6, Month 12
measure: IBD activity
timeFrame: Month 0, Month 6, Month 12
Secondary outcomes:
measure: Body Mass Index
timeFrame: Month 0, Month 6, Month 12
measure: Smoking status
timeFrame: Month 0, Month 6, Month 12
measure: Alcohol Consumption
timeFrame: Month 0, Month 6, Month 12
measure: Physical activity: International Physical Activity Questionnaire
timeFrame: Month 0, Month 6, Month 12
measure: IBD medication
timeFrame: Month 0, Month 6, Month 12
measure: IBD flares
timeFrame: Month 0, Month 6, Month 12
measure: Sleep - the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Month 0, Month 6, Month 12
measure: Diet - Healthy Eating Assessment
timeFrame: Month 0, Month 6, Month 12
measure: IBD quality of life - short Inflammatory Bowel Disease Questionnaire (sIBDQ)
timeFrame: Month 0, Month 6, Month 12
measure: Medication Adherence - Medication Adherence Report Scale (MARS)
timeFrame: Month 0, Month 6, Month 12
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Rona Moss-Morris, PhD
role: PRINCIPAL_INVESTIGATOR
References: