Skip to content

Mindfulness Therapy in Inflammatory Bowel Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02963246
Acronym
Mindfulness
Enrollment
60
Registered
2016-11-15
Start date
2017-05-05
Completion date
2018-03-14
Last updated
2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Disease

Keywords

mindfulness, quality of life, Bowel Disease

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.

Interventions

BEHAVIORALMindfulness

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.

Sponsors

Cardenal Herrera University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
inflammation stress markers (reactive Protein C and faecal calprotectin)Change from Baseline inflammation stress markers at 12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026