Mindfulness Therapy in Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Bowel Disease
• Interventions: Behavioral: Mindfulness

• Registration Number: NCT02963246
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-15
• Study Start: 2017-05-05
• Primary Completion: 2018-02-05
• Study Completion: 2018-03-14
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness group	Mindfulness	Mindfulness intervention (12 months). Mindfulness based Cognitive Therapy is an evidence-based psychological program designed to help manage depressive and stress symptoms.

Primary Outcome Measures

Name	Time	Method
Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)	Change from Baseline IBDQ-32 score at 12 months

Secondary Outcome Measures

Name	Time	Method
inflammation stress markers (reactive Protein C and faecal calprotectin)	Change from Baseline inflammation stress markers at 12 months

Trial Locations

Locations (1)

Universidad CEU Cardenal Herrera; 🇪🇸 Elche, Spain