The Effects of a Mindfulness Based Intervention on IBD Disability

NCT05944068 | Unknown

• 1 other identifier: S67980
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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, 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).

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  6 months

Other Outcomes (1)

• Evolution of C-reactive protein and fecal calprotectin over time

  12 months

Study Arms (2)

Early intervention group

EXPERIMENTAL

This group will receive the intervention immediately after baseline.

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

Behavioral: midfulness training

Interventions

midfulness training BEHAVIORAL

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.

Early intervention group; Late intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Marc Ferrante

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Ferrante, MD PhD

CONTACT

00321642845; marc.ferrante@uzleuven.be

Bep Keersmaekers

CONTACT

003216340250; bep.keersmaekers@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 13, 2023
• Study Start: March 6, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 4, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)