Back to resultsMindfulness Therapy in Inflammatory Bowel Disease (Mindfulness)
Primary Purpose
Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
About this trial
This is an interventional treatment trial for Bowel Disease focused on measuring mindfulness, quality of life, Bowel Disease
Eligibility 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
Sites / Locations
- Universidad CEU Cardenal Herrera
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness group
Control Group
Arm Description
Mindfulness intervention (12 months). Mindfulness based Cognitive Therapy is an evidence-based psychological program designed to help manage depressive and stress symptoms.
Treatment-as-usual control
Outcomes
Primary Outcome Measures
Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)
Secondary Outcome Measures
inflammation stress markers (reactive Protein C and faecal calprotectin)
Full Information
NCT ID
NCT02963246
First Posted
November 8, 2016
Last Updated
July 17, 2018
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT02963246
Brief Title
Mindfulness Therapy in Inflammatory Bowel Disease
Acronym
Mindfulness
Official Title
Effects of a Mindfulness Therapy Intervention for Individuals With Inflammatory Bowel Disease: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
February 5, 2018 (Actual)
Study Completion Date
March 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Disease
Keywords
mindfulness, quality of life, Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness group
Arm Type
Experimental
Arm Description
Mindfulness intervention (12 months). Mindfulness based Cognitive Therapy is an evidence-based psychological program designed to help manage depressive and stress symptoms.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Treatment-as-usual control
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
inflammation stress markers (reactive Protein C and faecal calprotectin)
Time Frame
Change from Baseline inflammation stress markers at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José M Soria, PhD
Organizational Affiliation
University CEU Cardenal Herrera. Plaza Reyes Católicos nº19 03204 Elche, Alicante, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Elche
ZIP/Postal Code
03204
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness Therapy in Inflammatory Bowel Disease
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