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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychological

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |