Crohn DiseaseEMBODYNCT05944068
The Effects of a Mindfulness Based Intervention on IBD Disability
A study testing midfulness training in people with Crohn Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
EMBODY (Effects of a Mindfulness Based interventiOn on ibD disabilitY) aims to evaluate the effects of a mindfulness based intervention on a broad number of disease related disability dimensions in patients with Crohn's disease (abdominal pain, regulation defecation, joint pain, energy, emotions, body image… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- midfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Mar 2024to 30 Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Males and females 18-80 years old.
- Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology
- Patients with more than one year of follow-up since diagnosis
- Patients having internet or smartphone access
- Patients being fluent in Dutch
Who cannot join
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Patients that initiated a new IBD medication (steroids, thiopurines, methotrexate, biologicals or small molecules) in the past three months
- Patients in whom a major surgery or acute surgery with hospitalization can be expected during the complete study period
- Patients with a present or past psychiatric disease diagnosis (psychosis, bipolar disease, substance abuse)
- Patients using psychotropic medication
- Patients with former experience of mindfulness training
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven
Marc Ferrante, MD PhD
About this study
EMBODY (Effects of a Mindfulness Based interventiOn on ibD disabilitY) aims to evaluate the effects of a mindfulness based intervention on a broad number of disease related disability dimensions in patients with Crohn's disease (abdominal pain, regulation defecation, joint pain, energy, emotions, body image, interpersonal interactions, education and work, sexual function, sleep). Besides, the investigators will measure the effect of the intervention on depression, anxiety, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity. It will be a prospective, randomized-controlled, monocentric, superiority trial using a waiting list with treatment as usual as control arm. Half of the patients will immediately start the mindfulness based intervention (early intervention group). In the other half, there will be a waiting time of 6 months before starting the mindfulness based intervention (late intervention or control group). Clinical disease activity (two-item patient reported outcome (PRO2)), faecal calprotectin and C-reactive protein (CRP) will be collected throughout the trial (pre-, during and post-intervention). The investigators will measure IBD-related disability through the IBD-Disk, a tool for assessing the impact of the disease on ten different dimensions of everyday life dimensions. Depression, anxiety and Stress will be investigated via the Depression Anxiety Stress Scale Short Form (DASS21). Disease acceptance and perceived control will be measured using the Subjective Health Experience (SHE) model. Evolution of the different variables will be compared between both groups (ANOVA).
Read the detailed description
Crohn's disease (CD), next to ulcerative colitis (UC), is an inflammatory bowel disease (IBD) and causes chronic inflammation of the intestine. Patients suffer from chronic or relapsing symptoms as diarrhea, rectal blood loss, abdominal pain, nausea and weight loss. Next to physical symptoms, a large number of Crohn's disease patients present psychological distress, due to the large impact the disease has on daily life functioning. Depression and anxiety, as well as chronic fatigue are more prevalent in patients with Crohn's disease compared to healthy controls. The disease also significantly affects other biopsychosocial factors, including interpersonal relationships, educational or work-related activities, body image, sleep and sexual functioning. The impact of the disease on these factors translates to the amount of disease related disability Crohn's patients experience during daily life.
With this study, the investigators will evaluate the effects of a mindfulness based psychological intervention on a broad number of disease related disability factors in patients with Crohn's disease. Besides, they would like to measure the effect of the intervention on perceived stress, disease acceptance and perceived control as well as (biomarkers of) disease activity.
In many patients with Crohn's disease, objective markers of inflammation deviate from subjective health outcomes. For instance, patients may report impairing symptoms even in the absence of active disease, often resulting in comorbid psychological distress. Nearly 80% of those with active disease and 50% of those with inactive IBD report substantial fatigue that impairs their health related quality of life (HRQoL). Next to fatigue, other life domains measured by the IBD Disk, a short instrument that can clinically be used as a measure of patient-reported IBD-related disability, are abdominal pain, regulated defecation, interpersonal interactions, education and work, sleep, emotions, body image, sexual functions, and joint pain.
The relation between IBD and stress is bidirectional. Not only are patients with IBD who are experiencing symptoms more likely to have higher levels of perceived stress, but perceived stress also has a strong and consistent association with concurrent and subsequent IBD symptoms. Furthermore, the intervention of choice (mindfulness) was originally developed as a stress reduction method. Depression and anxiety are also more prevalent in the IBD population compared to healthy controls. But not only does the disease influence mental health, mental health will also affect disease activity. A study by Gracie et al. documented a nearly sixfold increase in risk for anxiety symptoms in those with normal anxiety levels but active IBD at baseline. The same study showed a twofold increase in risk of IBD flares, need for steroids and escalation therapy in those with higher anxiety but quiescent IBD activity at baseline. Hence, the investigators chose to also measure depression, anxiety and stress by means of the Depression Anxiety Stress Scale Short Form (DASS21).
Two other important psychological determinants of subjective health are disease acceptance and perceived control over the disease, both integrated in the SHE model. The definition given by Bloem and Stalpers for disease acceptance is "the feeling by the individual that his health condition and the possible constraints on functioning resulting from it, are acceptable and fitting for him as a person" and for perceived control "the belief of the individual that his health condition, in the individual's perception, can be influenced or controlled by himself or by others".
For this study the investigators chose for a mindfulness based intervention. Mindfulness is defined as the ability to notice and observe details about one's present internal and external environment with the goal of non-judgemental and non-elaborative awareness of cognitions, emotions and physical sensations. This allows for reflective (taking time for reflecting) versus reflexive (resulting from behavioral reflexes) reactions to situations or feelings. Mindfulness is achieved through a standard practice, including meditation, body scan practices, yoga and guided focus on different body parts.
Baer et al. proposed five mechanisms by which mindfulness might work to improve symptoms and mood: (1) exposure, by encouraging patients to experience and accept unpleasant sensations without avoidance, (2) cognitive change, by shifting the conceptualization of negative thinking from "reflections of truth" to "just thoughts", (3) self-management, by improving coping skills through enhancing awareness of thoughts, emotions and sensations, (4) relaxation, by indirectly reducing physical tension and autonomic arousal, and (5) acceptance, by promoting non-judgemental awareness of one's own personal experience and reducing maladaptive behaviours aimed at changing the experience.
The goal of the mindfulness intervention will be to teach patients a way of coping with negative emotions without acting on them, letting patients take control of their disease related behaviour and come to better disease acceptance. Where medical treatments fail to take away all disabling symptoms, psychological interventions like mindfulness could offer patients a coping method through which symptoms are experienced as less disabling and patients regain their quality of life. This research may further strengthen the need for a multidisciplinary approach in patients with Crohn's disease.
- Conditions
- Crohn Disease
- Being tested
- midfulness training
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midfulness trainingBehavioural
For this study we chose for a mindfulness based intervention. Mindfulness is defined as the ability to notice and observe details about one's present internal and external environment with the goal of non-judgemental and non-elaborative awareness of cognitions, emotions and physical sensations. The goal of the mindfulness intervention will be to teach patients a way of coping with negative emotions without acting on them, letting patients take control of their disease related behaviour and come to better disease acceptance. Where medical treatments fail to take away all disabling symptoms, psychological interventions like mindfulness could offer patients a coping method through which symptoms are experienced as less disabling and patients regain their quality of life. This research may further strengthen the need for a multidisciplinary approach in patients with Crohn's disease.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention group | Experimental | This group will receive the intervention immediately after baseline. Receives: Behavioral: midfulness training |
| Late intervention group | Other | This group will receive the intervention 6 months after baseline, in psychological studies called the waiting list group Receives: Behavioral: midfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median change in the IBD-related disability index by month 3
This study will evaluate if a mindfulness based intervention can improve IBD-related disability, measured through the IBD Disk. Patients are asked to rate each item on a scale from 0 to 10 (0 = absolutely disagree, 10 = absolutely agree), resulting in a total score ranging from 0 to 100. A higher score represents higher IBD-related disability.
Measured: 6 months
Secondary outcomes (1)
The median change in separate components of the IBD-related disability index, perceived stress, perceived control and disease acceptante by month 3
The median change in the seperate components of the IBD-related disability index by month 3.
Each item is rated on a scale from 0 to 10 (0 = absolutely disagree, 10 = absolutely agree). A higher score represents higher IBD-related disability.
The median change in the depression/anxiety/stress scale of the DASS21 by month 3. Each of the three scales contains 7 items. Items are rated on 4-point severity/frequency scales. Higher scores represent higher probability of depression, anxiety and/or stress.
The median change in the disease acceptance/perceived control component of the SHE model by month 3. The SHE model contains 6 questions with a scale from 1 to 7 (1=fully agree, 7=fully disagree). Higher scores represent higher perceived control/acceptance.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start6 Mar 2024
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- EMBODY (Effects of a Mindfulness Based interventiOn on ibD disabilitY) will be a prospective, randomized-controlled, monocentric, superiority trial using a waiting list with treatment as usual as control arm. Half of the patients will immediately start the mindfulness based intervention (early intervention group). In the other half, there will be a waiting time of 6 months before starting the mindfulness based intervention (late intervention or control group).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Ferrante, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944068
- Sponsor's protocol ID
- S67980
- Acronym
- EMBODY
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Mindfulness Based Intervention on IBD Disability
- ClinicalTrials.gov ID
- NCT05944068
- Acronym / sponsor ID
- EMBODY / S67980
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Jul 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.
EMBODY (Effects of a Mindfulness Based interventiOn on ibD disabilitY) aims to evaluate the effects of a mindfulness based intervention on a broad number of disease related disability dimensions in patients with Crohn's disease (abdominal pain, regulation defecation, joint pain, energy, emotions, body image, interpersonal interactions, education and work, sexual function, sleep). Besides, the investigators will measure the effect of the intervention on depression, anxiety, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity. It will be a prospective, randomized-controlled, monocentric, superiority trial using a waiting list with treatment as usual as control arm. Half of the patients will immediately start the mindfulness based intervention (early intervention group). In the other half, there will be a waiting time of 6 months before starting the mindfulness based intervention (late intervention or control group). Clinical disease activity (two-item patient reported outcome (PRO2)), faecal calprotectin and C-reactive protein (CRP) will be collected throughout the trial (pre-, during and post-intervention). The investigators will measure IBD-related disability through the IBD-Disk, a tool for assessing the impact of the disease on ten different dimensions of everyday life dimensions. Depression, anxiety and Stress will be investigated via the Depression Anxiety Stress Scale Short Form (DASS21). Disease acceptance and perceived control will be measured using the Subjective Health Experience (SHE) model. Evolution of the different variables will be compared between both groups (ANOVA).
Detailed description
Crohn's disease (CD), next to ulcerative colitis (UC), is an inflammatory bowel disease (IBD) and causes chronic inflammation of the intestine. Patients suffer from chronic or relapsing symptoms as diarrhea, rectal blood loss, abdominal pain, nausea and weight loss. Next to physical symptoms, a large number of Crohn's disease patients present psychological distress, due to the large impact the disease has on daily life functioning. Depression and anxiety, as well as chronic fatigue are more prevalent in patients with Crohn's disease compared to healthy controls. The disease also significantly affects other biopsychosocial factors, including interpersonal relationships, educational or work-related activities, body image, sleep and sexual functioning. The impact of the disease on these factors translates to the amount of disease related disability Crohn's patients experience during daily life.
With this study, the investigators will evaluate the effects of a mindfulness based psychological intervention on a broad number of disease related disability factors in patients with Crohn's disease. Besides, they would like to measure the effect of the intervention on perceived stress, disease acceptance and perceived control as well as (biomarkers of) disease activity.
In many patients with Crohn's disease, objective markers of inflammation deviate from subjective health outcomes. For instance, patients may report impairing symptoms even in the absence of active disease, often resulting in comorbid psychological distress. Nearly 80% of those with active disease and 50% of those with inactive IBD report substantial fatigue that impairs their health related quality of life (HRQoL). Next to fatigue, other life domains measured by the IBD Disk, a short instrument that can clinically be used as a measure of patient-reported IBD-related disability, are abdominal pain, regulated defecation, interpersonal interactions, education and work, sleep, emotions, body image, sexual functions, and joint pain.
The relation between IBD and stress is bidirectional. Not only are patients with IBD who are experiencing symptoms more likely to have higher levels of perceived stress, but perceived stress also has a strong and consistent association with concurrent and subsequent IBD symptoms. Furthermore, the intervention of choice (mindfulness) was originally developed as a stress reduction method. Depression and anxiety are also more prevalent in the IBD population compared to healthy controls. But not only does the disease influence mental health, mental health will also affect disease activity. A study by Gracie et al. documented a nearly sixfold increase in risk for anxiety symptoms in those with normal anxiety levels but active IBD at baseline. The same study showed a twofold increase in risk of IBD flares, need for steroids and escalation therapy in those with higher anxiety but quiescent IBD activity at baseline. Hence, the investigators chose to also measure depression, anxiety and stress by means of the Depression Anxiety Stress Scale Short Form (DASS21).
Two other important psychological determinants of subjective health are disease acceptance and perceived control over the disease, both integrated in the SHE model. The definition given by Bloem and Stalpers for disease acceptance is "the feeling by the individual that his health condition and the possible constraints on functioning resulting from it, are acceptable and fitting for him as a person" and for perceived control "the belief of the individual that his health condition, in the individual's perception, can be influenced or controlled by himself or by others".
For this study the investigators chose for a mindfulness based intervention. Mindfulness is defined as the ability to notice and observe details about one's present internal and external environment with the goal of non-judgemental and non-elaborative awareness of cognitions, emotions and physical sensations. This allows for reflective (taking time for reflecting) versus reflexive (resulting from behavioral reflexes) reactions to situations or feelings. Mindfulness is achieved through a standard practice, including meditation, body scan practices, yoga and guided focus on different body parts.
Baer et al. proposed five mechanisms by which mindfulness might work to improve symptoms and mood: (1) exposure, by encouraging patients to experience and accept unpleasant sensations without avoidance, (2) cognitive change, by shifting the conceptualization of negative thinking from "reflections of truth" to "just thoughts", (3) self-management, by improving coping skills through enhancing awareness of thoughts, emotions and sensations, (4) relaxation, by indirectly reducing physical tension and autonomic arousal, and (5) acceptance, by promoting non-judgemental awareness of one's own personal experience and reducing maladaptive behaviours aimed at changing the experience.
The goal of the mindfulness intervention will be to teach patients a way of coping with negative emotions without acting on them, letting patients take control of their disease related behaviour and come to better disease acceptance. Where medical treatments fail to take away all disabling symptoms, psychological interventions like mindfulness could offer patients a coping method through which symptoms are experienced as less disabling and patients regain their quality of life. This research may further strengthen the need for a multidisciplinary approach in patients with Crohn's disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- EMBODY (Effects of a Mindfulness Based interventiOn on ibD disabilitY) will be a prospective, randomized-controlled, monocentric, superiority trial using a waiting list with treatment as usual as control arm. Half of the patients will immediately start the mindfulness based intervention (early intervention group). In the other half, there will be a waiting time of 6 months before starting the mindfulness based intervention (late intervention or control group).
| Arm | Type | Receives |
|---|---|---|
| Early intervention group | Experimental | Behavioral: midfulness trainingThis group will receive the intervention immediately after baseline. |
| Late intervention group | Other | Behavioral: midfulness trainingThis group will receive the intervention 6 months after baseline, in psychological studies called the waiting list group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Males and females 18-80 years old.
- Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology
- Patients with more than one year of follow-up since diagnosis
- Patients having internet or smartphone access
Key exclusion criteria (6 listed)
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Patients that initiated a new IBD medication (steroids, thiopurines, methotrexate, biologicals or small molecules) in the past three months
- Patients in whom a major surgery or acute surgery with hospitalization can be expected during the complete study period
- Patients with a present or past psychiatric disease diagnosis (psychosis, bipolar disease, substance abuse)
- Patients using psychotropic medication
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 |
|---|---|---|
| midfulness trainingFor this study we chose for a mindfulness based intervention. Mindfulness is defined as the ability to notice and observe details about one's present internal and external environment with the goal of non-judgemental and non-elaborative awareness of cognitions, emotions and physical sensations. The goal of the mindfulness intervention will be to teach patients a way of coping with negative emotions without acting on them, letting patients take control of their disease related behaviour and come to better disease acceptance. Where medical treatments fail to take away all disabling symptoms, psychological interventions like mindfulness could offer patients a coping method through which symptoms are experienced as less disabling and patients regain their quality of life. This research may further strengthen the need for a multidisciplinary approach in patients with Crohn's disease. | Behavioural | Early intervention group, Late intervention group |
Primary outcome
The median change in the IBD-related disability index by month 3
Time frame: 6 months
This study will evaluate if a mindfulness based intervention can improve IBD-related disability, measured through the IBD Disk. Patients are asked to rate each item on a scale from 0 to 10 (0 = absolutely disagree, 10 = absolutely agree), resulting in a total score ranging from 0 to 100. A higher score represents higher IBD-related disability.
1 secondary outcome
The median change in separate components of the IBD-related disability index, perceived stress, perceived control and disease acceptante by month 3
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Marc Ferrante principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midfulness training in people with Crohn Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 6 inclusion and 6 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 4 Apr 2024. 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 Belgium. 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 Marc Ferrante, MD PhD (00321642845, marc.ferrante@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median change in the IBD-related disability index by month 3 (time frame: 6 months). 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 4 Apr 2024.