NCT02963246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

May 5, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

November 8, 2016

Last Update Submit

July 17, 2018

Conditions

Bowel Disease

Keywords

mindfulnessquality of lifeBowel Disease

Outcome Measures

Primary Outcomes (1)

  • Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)

    Change from Baseline IBDQ-32 score at 12 months

Secondary Outcomes (1)

  • inflammation stress markers (reactive Protein C and faecal calprotectin)

    Change from Baseline inflammation stress markers at 12 months

Study Arms (2)

Mindfulness group

EXPERIMENTAL

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

Behavioral: Mindfulness

Control Group

NO INTERVENTION

Treatment-as-usual control

Interventions

MindfulnessBEHAVIORAL

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.

Mindfulness group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • active disease symptoms
  • planned surgery
  • cognitive impairment
  • previous experience with mindfulness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Elche, 03204, Spain

Location

Related Publications (1)

  • 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.

    PMID: 40243391DERIVED

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • José M Soria, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 15, 2016

Study Start

May 5, 2017

Primary Completion

February 5, 2018

Study Completion

March 14, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)