Mindfulness-based Cognitive Therapy for Patients With Inflammatory Bowel Disease

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

BEHAVIORAL

Mindfulness-based cognitive therapy + TAU

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).

OTHER

Treatment as usual (TAU)

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

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• Donders Centre for Cognitive Neuroimaging

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Anne Speckens, Dr. · Radboud University Medical Center

• Loes Nissen, Dr. · Jeroen Bosch Ziekenhuis

• Marloes Huijbers, Dr. · Radboud University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-01

Primary Completion

2023-10-03

Completion

2023-10-03

Countries

• Netherlands

Study Locations