Mindfulness-Based Cognitive Therapy for Fatigue in Inflammatory Bowel Disease Patients: a Randomized Controlled Trial

NCT03162575 | Completed

• 1 other identifier: 2016.316
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) for reducing fatigue in Inflammatory Bowel Disease patients in remission.

Conditions

Psychological

Outcome Measures

Primary Outcomes (1)

• Change in fatigue

  Fatigue will be assessed with the Checklist Individual Strength (CIS-20)

  Change from baseline in severity of fatigue symptoms at 3 months, 6 months and 12 months

Secondary Outcomes (7)

• Change in fatigue interference

  Change from baseline in fatigue interference at 3 months, 6 months, and 12 months

• Change in anxiety

  Change from baseline in generalized anxiety at 3 months, 6 months, and 12 months

• Change in depression

  Change from baseline in depression at 3 months, 6 months, and 12 months

• Change in IBD-specific quality of life

  Change from baseline in quality of life at 3 months, 6 months, and 12 months

• Change in sleep quality

  Change from baseline in sleep quality at 3 months, 6 months, and 12 months

Study Arms (2)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2.5 hours

Behavioral: Mindfulness-Based Cognitive Therapy

Waiting List Control

NO INTERVENTION

Patients assigned to the waiting list condition will receive no intervention for three months and afterwards will receive MBCT

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

Structured MBCT intervention based on the protocol of Williams, Teasdale, and Segal (2002)

Also known as: MBCT

Mindfulness-Based Cognitive Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with either Crohn's disease or Ulcerative Colitis
• Currently in remission
• No expectation of a surgery in the upcoming three months
• Score on the subscale 'subjective fatigue' of the CIS (8 items) ≥ 35 (i.e. indicating severe fatigue)
• Age ≥ 18 and ≤ 75 years at the time of study entrance
• Being able to attend eight weekly group sessions of 2.5 hours in the hospital
• Being able to read, write, and speak Dutch.
• Written informed consent

You may not qualify if:

• Severe cognitive, neurological or psychiatric co-morbidity that could interfere with patients' participation and/or warrant other treatment, including acute suicidal ideations or behavior, diagnosis of schizophrenia or history of psychotic complaints, bipolar disorder, severe personality disorder, or history of clinically significant drug abuse or substance dependence
• Pregnancy
• Anemia (i.e. Hb \< 7.4 for women, \< 8.1 for men)
• Change in IBD medication (i.e. use of steroids) within 1 month before study entry
• Currently receiving psychological treatment for fatigue or for psychological/psychiatric problems.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, Netherlands

Location

Related Publications (2)

• 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: 40243391 DERIVED

• Bredero QM, Fleer J, Smink A, Kuiken G, Potjewijd J, Laroy M, Visschedijk MC, Russel M, van der Lugt M, Meijssen MAC, van der Wouden EJ, Dijkstra G, Schroevers MJ. Long-term treatment outcomes of mindfulness-based cognitive therapy for fatigue in patients with inflammatory bowel disease: Results of a randomized controlled trial. J Psychosom Res. 2024 Dec;187:111949. doi: 10.1016/j.jpsychores.2024.111949. Epub 2024 Oct 11.

  PMID: 39418854 DERIVED

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maya Schroevers, PhD

  Department of Health Sciences

  PRINCIPAL INVESTIGATOR

• Gerard Dijkstra, Prof.

  Center for Liver, Digestive and Metabolic Diseases (CLDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 22, 2017
• Study Start: July 18, 2017
• Primary Completion: May 30, 2018
• Study Completion: November 9, 2019
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)