Clinical trial NCT03162575: Mindfulness-Based Cognitive Therapy for Fatigue in Inflammatory Bowel Disease Patients: a Randomized Controlled Trial
Official title: The Possible Beneficial Effects of Mindfulness-Based Cognitive Therapy (MBCT) in Fatigued Adult Patients With Inflammatory Bowel Disease (IBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in fatigue
timeFrame: Change from baseline in severity of fatigue symptoms at 3 months, 6 months and 12 months
Secondary outcomes:
measure: Change in fatigue interference
timeFrame: Change from baseline in fatigue interference at 3 months, 6 months, and 12 months
measure: Change in anxiety
timeFrame: Change from baseline in generalized anxiety at 3 months, 6 months, and 12 months
measure: Change in depression
timeFrame: Change from baseline in depression at 3 months, 6 months, and 12 months
measure: Change in IBD-specific quality of life
timeFrame: Change from baseline in quality of life at 3 months, 6 months, and 12 months
measure: Change in sleep quality
timeFrame: Change from baseline in sleep quality at 3 months, 6 months, and 12 months
measure: Change in labor participation
timeFrame: Change from baseline in labor participation at 3 months, 6 months, and 12 months
measure: Satisfaction with treatment
timeFrame: Assessed at 3 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: Department of Health Sciences
name: Maya Schroevers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Liver, Digestive and Metabolic Diseases (CLDM)
name: Gerard Dijkstra, Prof.
role: PRINCIPAL_INVESTIGATOR
References: