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Mindfulness-Based Cognitive Therapy (MBCT) in Fatigued Patients With Inflammatory Bowel Disease (IBD)

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ClinicalTrials.gov Identifier: NCT03162575
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Psychological Behavioral: Mindfulness-Based Cognitive Therapy

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Possible Beneficial Effects of Mindfulness-Based Cognitive Therapy (MBCT) in Fatigued Adult Patients With Inflammatory Bowel Disease (IBD)
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mindfulness-Based Cognitive Therapy
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
Structured MBCT intervention based on the protocol of Williams, Teasdale, and Segal
Other Name: MBCT
No Intervention: Waiting List Control
Patients assigned to the waiting list condition will receive no intervention for three months and afterwards will receive MBCT


Outcome Measures

Primary Outcome Measures :
  1. Change in fatigue [ Time Frame: Change from baseline in severity of fatigue symptoms at 3 months, 6 months and 12 months ]
    Fatigue will be assessed with the Checklist Individual Strength (CIS-20)


Secondary Outcome Measures :
  1. Change in fatigue interference [ Time Frame: Change from baseline in fatigue interference at 3 months, 6 months, and 12 months ]
    Fatigue interference will be measured by the Fatigue Symptom Inventory (FSI)

  2. Change in anxiety [ Time Frame: Change from baseline in generalized anxiety at 3 months, 6 months, and 12 months ]
    Anxiety will be measured by Generalised Anxiety Disorder Assessment (GAD 7)

  3. Change in depression [ Time Frame: Change from baseline in depression at 3 months, 6 months, and 12 months ]
    Depression will be measured by Beck Depression Inventory-II (BDI-II)

  4. Change in IBD-specific quality of life [ Time Frame: Change from baseline in quality of life at 3 months, 6 months, and 12 months ]
    IBD-specific quality of life will be measured by the IBD-Q

  5. Change in sleep quality [ Time Frame: Change from baseline in sleep quality at 3 months, 6 months, and 12 months ]
    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  6. Change in labor participation [ Time Frame: Change from baseline in labor participation at 3 months, 6 months, and 12 months ]
    Labor participation will be assessed with several questions

  7. Satisfaction with treatment [ Time Frame: Assessed at 3 months ]
    Satisfaction with treatment will be assessed with several questions


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162575


Contacts
Contact: Annika Tovote, PhD +31 (0)50 3616905 k.a.tovote@umcg.nl
Contact: Joke Fleer, PhD +31 (0)50 3616645 j.fleer@umcg.nl

Locations
Netherlands
UMCG Recruiting
Groningen, Netherlands
Contact: Annika Tovote, Dr.    0031(0)503632955    k.a.tovote@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Maya Schroevers, PhD Department of Health Sciences
Principal Investigator: Gerard Dijkstra, Prof. Center for Liver, Digestive and Metabolic Diseases (CLDM)
More Information

Responsible Party: Maya Schroevers, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03162575     History of Changes
Other Study ID Numbers: 2016.316
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis