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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162575
• Other study ID #: 2016.316
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: November 9, 2019

Study information

• Verified date: May 2021
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 9, 2019
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Psychological

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy
Structured MBCT intervention based on the protocol of Williams, Teasdale, and Segal (2002)

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Satisfaction with treatment	Satisfaction with treatment will be assessed with several questions	Assessed at 3 months