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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness group | Experimental | Mindfulness intervention (12 months). Mindfulness based Cognitive Therapy is an evidence-based psychological program designed to help manage depressive and stress symptoms. |
|
| Control Group | No Intervention | Treatment-as-usual control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| inflammation stress markers (reactive Protein C and faecal calprotectin) | Change from Baseline inflammation stress markers at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José M Soria, PhD | University CEU Cardenal Herrera. Plaza Reyes Católicos nº19 03204 Elche, Alicante, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad CEU Cardenal Herrera | Elche | 03204 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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