CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
Mindfulness-based cognitive therapy + TAU +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04646785
NCT04646785N/ACompleted

Mindfulness-based Cognitive Therapy to Improve Stress and Sleep in Patients With Inflammatory Bowel Disease

Radboud University Medical Center·interventional·Posted Nov 30, 2020·Updated Jan 24, 2024

In Brief

A clinical study evaluating Mindfulness-based cognitive therapy + TAU and Treatment as usual (TAU) for Inflammatory Bowel Diseases. Completed, enrolled 142 participants across 4 sites.

Detailed Summary

Considering the limited availability of psychosocial interventions for IBD, this study aims to investigate MBCT as an adjunctive treatment to treatment as usual to reduce psychological stress and improve sleep quality/regularity in patients with IBD who report elevated stress levels. The study will have a follow-up duration of 12 months from baseline.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 30, 2020
Enrollment StartAug 1, 2021
Primary CompletionOct 3, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.6 years ago

Interventions

Mindfulness-based cognitive therapy + TAUbehavioral

The proposed intervention is mindfulness-based cognitive therapy (MBCT), based on the protocol published by Segal, Williams and Teasdale. MBCT consists of eight weekly 2.5h group sessions, a six-hour silent day and daily home practice assignments guided by audio files. The program includes both formal and informal meditation exercises. Cognitive techniques include monitoring and scheduling of activities, identification of negative automatic thoughts and devising a relapse prevention plan. Psycho-education and interactive dialogue typically focus on stress management, balancing activities, and (lifestyle) strategies to stay well in the future (relapse prevention).

Treatment as usual (TAU)other

Treatment as usual (TAU) according Dutch and European IBD treatment guidelines. TAU focuses on pharmacological and surgical disease control, and prevention of complications.