Mindfulness Therapy in Inflammatory Bowel Disease

NCT ID: NCT02963246

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2018-03-14

Brief Summary

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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

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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.

Conditions

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Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness group

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

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

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.

Control Group

Treatment-as-usual control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Jose Miguel Soria Lopez

PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José M Soria, PhD

Role: PRINCIPAL_INVESTIGATOR

University CEU Cardenal Herrera. Plaza Reyes Católicos nº19 03204 Elche, Alicante, Spain

Locations

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Universidad CEU Cardenal Herrera

Elche, , Spain

Site Status

Countries

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Spain

References

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Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

Reference Type DERIVED
PMID: 40243391 (View on PubMed)

Other Identifiers

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UNIVERSITY CARDENAL HERRERA-4

Identifier Type: -

Identifier Source: org_study_id

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