Mindfulness Therapy in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual control group in patients with bowel disease. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.

Detailed Description
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Background: Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms. Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-as usual control group in patients with bowel disease. Outcome measures: quality of life, inflammatory and stress markers. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.

Official Title
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Effects of a Mindfulness Therapy Intervention for Individuals With Inflammatory Bowel Disease: A Randomized Controlled Trial

Conditions
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Bowel Disease

Intervention / Treatment
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* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with bowel disease diagnostic patients with non active disease symptoms in the last 3 month patients with access to internet and basic informatic knowledge Exclusion Criteria: active disease symptoms planned surgery cognitive impairment previous experience with mindfulness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness group<br>Mindfulness intervention (12 months). Mindfulness based Cognitive Therapy is an evidence-based psychological program designed to help manage depressive and stress symptoms. | Behavioral: Mindfulness<br>* Mindfulness-based therapy has been used effectively to treat a variety of physical and psychological disorders, including depression, anxiety, and chronic pain. Recently, several lines of research have explored the potential for mindfulness-therapy in treating somatization disorders, including fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome. Mindfulness-based therapies (MBT) are a clinical application involving the key element of nonjudgmental acceptance of physical pain or psychological distress, thereby reducing the tendency to ruminate over and catastrophise these experiences. In the present study, we propose a mindfulness intervention of 12 months, with sessions either personalized or online.<br>|
| No Intervention: Control Group<br>Treatment-as-usual control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire) |  | Change from Baseline IBDQ-32 score at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation stress markers (reactive Protein C and faecal calprotectin) |  | Change from Baseline inflammation stress markers at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, quality of life, Bowel Disease