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- INTRODUCTION

Inflammatory bowel diseases (IBD) mainly consisting of Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory conditions of the gastrointestinal tract. Many IBD patients suffer from psychological distress, reduced sleep quality and fatigue, for which only limited treatment options are available. This is associated with reduced quality of life and increased healthcare costs. The incidence of IBD is increasing worldwide. As mindfulness seems to improve psychological distress and quality of life in IBD [1] and improves sleep [2], MBCT might target three important health problems in patients with IBD. In addition, findings from this study may serve as a model for other chronic conditions.

 

-RESEARCH QUESTION

Does Mindfulness-Based Cognitive Therapy (MBCT) reduce psychological distress and improve sleep quality and quality of life compared to treatment as usual (TAU) in patients with IBD?

 

-HYPOTHESIS

We hypothesize that MBCT+TAU will be more effective than TAU alone in reducing stress in IBD patients with disease remission. In addition, we hypothesize that MBCT will be superior to TAU with regard to improvements in sleep quality/regularity and fatigue, and on IBD-related outcomes: IBD-related quality of life, and perceived control over IBD, clinical indicators (fecal calprotectin, c-reactive protein levels, Harvey Bradaw Index for CD, and the Simple Clinical Colitis Activity Index for UC), and relapse into IBD-related flares. Furthermore, we hypothesize that MBCT will improve general health outcomes: repetitive negative thinking, mindfulness skills, self-compassion skills, and positive mental health.

 

-STUDY DESIGN

A randomized, multicenter, clinical trial with assessments at baseline, post treatment (3 months later) and follow-ups at 6, 9 and 12 months after baseline. Objective sleep quality and sleep regularity will be measured immediately before and after the intervention and at the 12-month follow-up, for 10 consecutive nights each, in a naturalistic home-based setting using the novel wearable sleep EEG recorder iBand+, recently developed by the industry partner Arenar B.V.

 

A qualitative study will be embedded in the trial, including a subset of the trial participants for semi-structured interviews with regard to a) the usefulness of MBCT in coping with their illness and improving self-care, and b) the feasibility of MBCT, including possible barriers and facilitators for implementation.

 

-STUDY POPULATION

Adult IBD patients, i.e. Crohn’s Disease (CD), Ulcerative colitis (UC) or Indeterminate colitis (IC) in remission (Calprotectin < 250 mg/kg) and scoring >=11 on the Hospital Anxiety and Depression Scale (HADS).

 

-INTERVENTION

Mindfulness-Based Cognitive Therapy (MBCT) adapted to patients with IBD. MBCT consists of 8 weekly sessions of 2,5 hours each, a silent day and home practice. It teaches formal and informal meditation exercise and cognitive behavioral skills.

 

-USUAL CARE/COMPARISON

TAU according Dutch and European IBD treatment guidelines. TAU focuses on pharmacological and surgical disease control, and prevention of complications.

 

-OUTCOME MEASURES

-Primary outcome:

Psychological distress according to the HADS at post treatment.

-Secondary outcomes:

Sleep quality/regularity and fatigue.

IBD-specific: IBD-related quality of life, perceived control over IBD, clinical indicators (fecal calprotectin, c-reactive protein levels, Harvey Bradaw Index for CD, and the Simple Clinical Colitis Activity Index for UC), and relapse into IBD-related flares.

General: repetitive negative thinking, mindfulness skills, self-compassion skills, and positive mental health.

-Costs and utilities will be investigated to explore cost-effectiveness.

-Qualitative interviews will focus on usefulness and feasibility of MBCT.

 

-SAMPLE SIZE/DATA ANALYSIS

Based on the most recent meta-analysis of mindfulness-based interventions in IBD, we anticipate a reduction of psychological stress (effect size d = 0.51) [1]. With an error probability of 0.05, 0.80 power and a 1:1 allocation ratio, the required total sample size is 98. To account for dropout, we looked at dropout rates in the two RCTs with similar interventions (MBSR and MBCT for IBD), these were 11,5% [3] and 44% [4]. These rates were averaged, i.e. 28%. Using the following formula, N = n / (1-(z/100)), our corrected sample size is N=136 (n=68 per condition). Analyses will be based on the intention-to-treat sample.

 

TIME SCHEDULE

Study duration will be 48 months, from December 2020 until December 2024. The first six months will be used for preparation of the trial and submitting the ethics committee review. Participant recruitment will start from June 2021 until March 2023, with the final follow-up being completed in April 2024. The final eight months will be used for the final reports and submission of the manuscript.

 

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