Inflammatory Bowel DiseasesNCT06116331
The Mind-Body IBD Study: Understanding the Mind-body Connection in IBD
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Data collection
- How many people
- 170 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with IBD in the UK, who have experienced a flare within the last 2 years.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE1 9RT
Natasha Seaton, 0207 188 1189, natasha.seaton@kcl.ac.uk
0207 188 1189, mindbody-ibd@kcl.ac.uk
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Data collection
- Keywords
- mental health, depression, anxiety, psychology, health, exercise, stress, diet, sleep, adherence
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Psychological Well-Being, Depression, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Participants will answer questionnaires and submit stool samples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Month 0, Month 6, Month 12
Fecal Calprotectin
Measure of intestinal inflammation, higher levels indicate greater inflammation.
Measured: 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.
Measured: 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.
Measured: Month 0, Month 6, Month 12
Secondary outcomes (10)
Body Mass Index
Weight (in kg) and Height (in m) will be combined to calculate BMI (weight in kg / (height in m)^2
Measured: Month 0, Month 6, Month 12
Smoking status
Current smoking status, including amount of cigarettes consumed per day.
Measured: Month 0, Month 6, Month 12
Alcohol Consumption
Number of units drunk in the past week.
Measured: 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.
Measured: Month 0, Month 6, Month 12
IBD medication
Current medication and dose.
Measured: Month 0, Month 6, Month 12
IBD flares
Frequency and severity (4-point scale) of IBD flares (in last 6 months)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 0, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Rona Moss-Morris, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116331
- Sponsor's protocol ID
- 33844
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mind-Body IBD Study: Understanding the Bidirectional Relationship Between Depression and Anxiety With Physical Health Outcomes and Inflammation
- ClinicalTrials.gov ID
- NCT06116331
- Acronym / sponsor ID
- 33844
- Keywords
- mental health, depression, anxiety, psychology, health, exercise, stress, diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Data collectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with IBD in the UK, who have experienced a flare within the last 2 years.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionParticipants will answer questionnaires and submit stool samples. | Other | Participants |
Primary outcome
Psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Time frame: Month 0, Month 6, Month 12
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.
Depression: Patient Health Questionnaire - (PHQ-9)
Time frame: Month 0, Month 6, Month 12
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression.
Anxiety: Generalised Anxiety Disorder scale (GAD-7)
Time frame: Month 0, Month 6, Month 12
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
Fecal Calprotectin
Time frame: Month 0, Month 6
Measure of intestinal inflammation, higher levels indicate greater inflammation.
Health service use
Time frame: Month 0, Month 6, Month 12
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.
IBD activity
Time frame: Month 0, Month 6, Month 12
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.
10 secondary outcomes
Body Mass Index
Time frame: Month 0, Month 6, Month 12
Smoking status
Time frame: Month 0, Month 6, Month 12
Alcohol Consumption
Time frame: Month 0, Month 6, Month 12
Physical activity: International Physical Activity Questionnaire
Time frame: Month 0, Month 6, Month 12
IBD medication
Time frame: Month 0, Month 6, Month 12
IBD flares
Time frame: Month 0, Month 6, Month 12
Sleep - the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Month 0, Month 6, Month 12
Diet - Healthy Eating Assessment
Time frame: Month 0, Month 6, Month 12
IBD quality of life - short Inflammatory Bowel Disease Questionnaire (sIBDQ)
Time frame: Month 0, Month 6, Month 12
Medication Adherence - Medication Adherence Report Scale (MARS)
Time frame: Month 0, Month 6, Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Study information and sign upLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rona Moss-Morris, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasha Seaton, MSc (0207 188 1189, natasha.seaton@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) (time frame: Month 0, Month 6, Month 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.