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Mindfulness Therapy in Inflammatory Bowel Disease (Mindfulness)

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ClinicalTrials.gov Identifier: NCT02963246
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jose Miguel Soria Lopez, Cardenal Herrera University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bowel Disease Behavioral: Mindfulness Not Applicable

Detailed Description:

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)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : February 5, 2018
Actual Study Completion Date : March 14, 2018

Arm Intervention/treatment
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.
Behavioral: Mindfulness

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
Treatment-as-usual control



Primary Outcome Measures :
  1. Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire) [ Time Frame: Change from Baseline IBDQ-32 score at 12 months ]

Secondary Outcome Measures :
  1. inflammation stress markers (reactive Protein C and faecal calprotectin) [ Time Frame: Change from Baseline inflammation stress markers at 12 months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Spain
Universidad CEU Cardenal Herrera
Elche, Spain, 03204
Sponsors and Collaborators
Cardenal Herrera University
Investigators
Principal Investigator: José M Soria, PhD University CEU Cardenal Herrera. Plaza Reyes Católicos nº19 03204 Elche, Alicante, Spain

Responsible Party: Jose Miguel Soria Lopez, PhD, Professor, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT02963246     History of Changes
Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-4
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jose Miguel Soria Lopez, Cardenal Herrera University:
mindfulness
quality of life
Bowel Disease

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis