An observational study in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by King's College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by King's College London · Observational
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.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 170 is above the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with IBD in the UK, who have experienced a flare within the last 2 years.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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
Time frame: Month 0, Month 6, Month 12
Fecal Calprotectin
Measure of intestinal inflammation, higher levels indicate greater inflammation.
Time frame: 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.
Time frame: 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.
Time frame: Month 0, Month 6, Month 12
Body Mass Index
Weight (in kg) and Height (in m) will be combined to calculate BMI (weight in kg / (height in m)\^2
Time frame: Month 0, Month 6, Month 12
Smoking status
Current smoking status, including amount of cigarettes consumed per day.
Time frame: Month 0, Month 6, Month 12
Alcohol Consumption
Number of units drunk in the past week.
Time frame: 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.
Time frame: Month 0, Month 6, Month 12
IBD medication
Current medication and dose.
Time frame: Month 0, Month 6, Month 12
IBD flares
Frequency and severity (4-point scale) of IBD flares (in last 6 months)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 0, Month 6, Month 12
Plan to share: Undecided
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