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Completed

NCT Number: NCT02963246

Mindfulness Therapy in Inflammatory Bowel Disease

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.

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Key information

Conditions

Bowel Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Elche, 03204, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness

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.

Primary outcomes

  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 outcomes

  1. inflammation stress markers (reactive Protein C and faecal calprotectin)

    Time frame: Change from Baseline inflammation stress markers at 12 months

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Effects of a Mindfulness Therapy Intervention for Individuals With Inflammatory Bowel Disease: A Randomized Controlled Trial

Acronym: Mindfulness

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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