Mindfulness-Based Cognitive Therapy for Fatigue in Inflammatory Bowel Disease Patients: a Randomized Controlled Trial
Primary Purpose
Psychological
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Psychological
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.
Sites / Locations
- UMCG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness-Based Cognitive Therapy
Waiting List Control
Arm Description
The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2.5 hours
Patients assigned to the waiting list condition will receive no intervention for three months and afterwards will receive MBCT
Outcomes
Primary Outcome Measures
Change in fatigue
Fatigue will be assessed with the Checklist Individual Strength (CIS-20)
Secondary Outcome Measures
Change in fatigue interference
Fatigue interference will be measured by the Fatigue Symptom Inventory (FSI)
Change in anxiety
Anxiety will be measured by Generalised Anxiety Disorder Assessment (GAD 7)
Change in depression
Depression will be measured by Beck Depression Inventory-II (BDI-II)
Change in IBD-specific quality of life
IBD-specific quality of life will be measured by the IBD-Q
Change in sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index
Change in labor participation
Labor participation will be assessed with several questions
Satisfaction with treatment
Satisfaction with treatment will be assessed with several questions
Full Information
NCT ID
NCT03162575
First Posted
May 1, 2017
Last Updated
May 26, 2021
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT03162575
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
November 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Cognitive Therapy
Arm Type
Experimental
Arm Description
The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2.5 hours
Arm Title
Waiting List Control
Arm Type
No Intervention
Arm Description
Patients assigned to the waiting list condition will receive no intervention for three months and afterwards will receive MBCT
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy
Other Intervention Name(s)
MBCT
Intervention Description
Structured MBCT intervention based on the protocol of Williams, Teasdale, and Segal (2002)
Primary Outcome Measure Information:
Title
Change in fatigue
Description
Fatigue will be assessed with the Checklist Individual Strength (CIS-20)
Time Frame
Change from baseline in severity of fatigue symptoms at 3 months, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in fatigue interference
Description
Fatigue interference will be measured by the Fatigue Symptom Inventory (FSI)
Time Frame
Change from baseline in fatigue interference at 3 months, 6 months, and 12 months
Title
Change in anxiety
Description
Anxiety will be measured by Generalised Anxiety Disorder Assessment (GAD 7)
Time Frame
Change from baseline in generalized anxiety at 3 months, 6 months, and 12 months
Title
Change in depression
Description
Depression will be measured by Beck Depression Inventory-II (BDI-II)
Time Frame
Change from baseline in depression at 3 months, 6 months, and 12 months
Title
Change in IBD-specific quality of life
Description
IBD-specific quality of life will be measured by the IBD-Q
Time Frame
Change from baseline in quality of life at 3 months, 6 months, and 12 months
Title
Change in sleep quality
Description
Sleep quality will be measured by the Pittsburgh Sleep Quality Index
Time Frame
Change from baseline in sleep quality at 3 months, 6 months, and 12 months
Title
Change in labor participation
Description
Labor participation will be assessed with several questions
Time Frame
Change from baseline in labor participation at 3 months, 6 months, and 12 months
Title
Satisfaction with treatment
Description
Satisfaction with treatment will be assessed with several questions
Time Frame
Assessed at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Schroevers, PhD
Organizational Affiliation
Department of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerard Dijkstra, Prof.
Organizational Affiliation
Center for Liver, Digestive and Metabolic Diseases (CLDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMCG
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness-Based Cognitive Therapy for Fatigue in Inflammatory Bowel Disease Patients: a Randomized Controlled Trial
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