Mindfulness Therapy in Inflammatory Bowel Disease (Mindfulness)
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|ClinicalTrials.gov Identifier: NCT02963246|
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bowel Disease||Behavioral: Mindfulness||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of a Mindfulness Therapy Intervention for Individuals With Inflammatory Bowel Disease: A Randomized Controlled Trial|
|Actual Study Start Date :||May 5, 2017|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: Mindfulness group
Mindfulness intervention (12 months). Mindfulness based Cognitive Therapy is an evidence-based psychological program designed to help manage depressive and stress symptoms.
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.
No Intervention: Control Group
- Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire) [ Time Frame: Change from Baseline IBDQ-32 score at 12 months ]
- inflammation stress markers (reactive Protein C and faecal calprotectin) [ Time Frame: Change from Baseline inflammation stress markers at 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963246
|Contact: Xavier Cortés, PhDemail@example.com|
|Contact: Juan F Lisón, PhDfirstname.lastname@example.org|
|Universidad CEU Cardenal Herrera||Recruiting|
|Elche, Spain, 03204|
|Contact: Jose Miguel Soria, PhD email@example.com|
|Principal Investigator:||José M Soria, PhD||University CEU Cardenal Herrera. Plaza Reyes Católicos nº19 03204 Elche, Alicante, Spain|