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

Psychological Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Psychological

• NCT number: NCT03162575
• Study type: Interventional
• Source: University Medical Center Groningen
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Completion date: November 9, 2019