Effects of a Mindfulness Therapy Intervention for Individuals With Inflammatory Bowel Disease: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bowel Disease
- Sponsor
- Cardenal Herrera University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jose Miguel Soria Lopez
PhD, Professor
Cardenal Herrera University
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
Outcomes
Primary Outcomes
Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)
Time Frame: Change from Baseline IBDQ-32 score at 12 months
Secondary Outcomes
- inflammation stress markers (reactive Protein C and faecal calprotectin)(Change from Baseline inflammation stress markers at 12 months)