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

The Possible Beneficial Effects of Mindfulness-Based Cognitive Therapy (MBCT) in Fatigued Adult Patients With Inflammatory Bowel Disease (IBD)

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

Study Overview

• Status: Completed
• Conditions: Psychological
• Intervention / Treatment: Behavioral: Mindfulness-Based Cognitive Therapy

Detailed Description

Fatigue is highly prevalent in patients with inflammatory bowel disease (IBD, i.e. Crohn's disease and ulcerative colitis), and may negatively impact patients' illness management, treatment adherence, and quality of life. Given this burden, effective treatment for reducing fatigue in IBD patients is warranted. A promising psychological treatment is Mindfulness-Based Cognitive Therapy (MBCT). MBCT is a standardized, highly structured eight-week group program for reducing stress, depression, fatigue and/or pain. Several meta-analyses have demonstrated the effectiveness of MBCT in reducing psychological complaints and improving quality of life. Moreover, in patients with cancer or chronic fatigue syndrome, there is preliminary evidence that MBCT can be effective in reducing fatigue. Given this lack of evidence for the efficacy of MBCT in reducing fatigue in general and the specific and strongly illness-related nature of fatigue in patients with IBD and characteristics of the illness, including its lifelong and relapsing nature, there is a need to verify whether MBCT is effective in reducing fatigue in IBD patients with severe fatigue.

This randomized controlled trial (RCT) aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) in reducing fatigue in severely fatigued IBD patients. Additionally, the effects of MBCT on clinically relevant secondary outcomes will be examined: fatigue interference, mood, IBD-specific quality of life, sleep quality, labor participation. Also patients' satisfaction will be assessed. Moreover, mediators and moderators will be examined to increase the understanding of why and for whom MBCT is particularly effective.

A randomized controlled trial will be performed, including two conditions: MBCT and a waitlist control group (who will receive MBCT after a waiting period of three months). The study sample will consist of 128 adult patients with IBD in remission and experiencing severe fatigue.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • UMCG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Cognitive Therapy; 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; Structured MBCT intervention based on the protocol of Williams, Teasdale, and Segal (2002); Other Names: MBCT
No Intervention: Waiting List Control; Patients assigned to the waiting list condition will receive no intervention for three months and afterwards will receive MBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue interference	Fatigue interference will be measured by the Fatigue Symptom Inventory (FSI)	Change from baseline in fatigue interference at 3 months, 6 months, and 12 months
Change in anxiety	Anxiety will be measured by Generalised Anxiety Disorder Assessment (GAD 7)	Change from baseline in generalized anxiety at 3 months, 6 months, and 12 months
Change in depression	Depression will be measured by Beck Depression Inventory-II (BDI-II)	Change from baseline in depression at 3 months, 6 months, and 12 months
Change in IBD-specific quality of life	IBD-specific quality of life will be measured by the IBD-Q	Change from baseline in quality of life at 3 months, 6 months, and 12 months
Change in sleep quality	Sleep quality will be measured by the Pittsburgh Sleep Quality Index	Change from baseline in sleep quality at 3 months, 6 months, and 12 months
Change in labor participation	Labor participation will be assessed with several questions	Change from baseline in labor participation at 3 months, 6 months, and 12 months
Satisfaction with treatment	Satisfaction with treatment will be assessed with several questions	Assessed at 3 months

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Maya Schroevers, PhD, Department of Health Sciences; Principal Investigator: Gerard Dijkstra, Prof., Center for Liver, Digestive and Metabolic Diseases (CLDM)

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): November 9, 2019

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2016.316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No