Mindfulness-based cognitive therapy to improve stress and reduce sleep in patients with inflammatory bowel disease

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 and improves
sleep, 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.

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.

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?

A randomized, parallel multicenter, controlled clinical trial with a treatment
as usual (TAU) control group and Mindfulness-based cognitive therapy (MBCT)+TAU
intervention group.

The intervention group will receive Mindfulness-Based Cognitive Therapy (MBCT)
in addition to treatment as usual (TAU). 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. The control gorup will
receive TAU. which will consist of treatment according to Dutch and European
IBD treatment guidelines. TAU mainly focuses on pharmacological and surgical
disease control, and prevention of complications.

The patients will follow the 8 week MBC program with weekly 2.5 hours sessions
and are encouraged to practice MBCT in between. Furthermore, they will be asked
to fill in online questionnaires before the intervention (basesline) and at 3,
6, 9 and 12 months which will take approximately 30-60 minutes each. Objective
sleep quality and sleep regularity will be measured immediately before and
after the intervention (baseline and 3 months), for 14 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.
Thereby, sleep quality and regularity will also be measured during the 8 weeks
MBCT training, in a naturalistic home-based setting using the Fitbit activity
tracker. Time investment for the group receiving TAU is 6.5 hours and for the
group receiving MCT + TAU is 32.5 hours.

The risks associated with participated are expected to be low. Participants
learn mindfulness skills to cope with psychological distress in a more
effective way. This may include increased awareness of difficult emotions,
which may at first be confronting or overwhelming. This is a major topic that
will be discussed during MBCT and if participants show a clear increase in
symptoms, additional guidance will be offered. Participants are encouraged to
respect their boundaries (both physical and psychological) and are always free
to quit or adapt the practice as needed.