Mind-Body Medicine and Ulcerative Colitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Ali Keshavarzian, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01491997
First received: December 7, 2011
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

Stress has been linked to chronic health problems, particularly diseases involving inflammation-mediated tissue injury and organ failure. Accordingly, it is not surprising that mind/body interventions are advocated for treatment of chronic inflammatory diseases. One such candidate disease is ulcerative colitis (UC) because: (1) UC is a life-long, relapsing, disabling inflammatory disorder of the intestine that lacks a non-toxic, efficacious treatment; (2) the therapeutic goal is to improve quality of life by ameliorating disabling symptoms and preventing disease progression by preventing disease flare-up, (3) stress triggers UC flare-up by modifying intestinal function and inflammatory processes, highlighting the potential therapeutic benefit of reducing physiological stress responses. The purpose of this study is to see if either of two 8-week mind/body medicine courses has an effect in reducing stress and affecting the course and severity of UC. Both have been shown to benefit other aspects of health and well-being.


Condition Intervention Phase
Ulcerative Colitis
Behavioral: Mind/Body Medicine Course 1
Behavioral: Mind/Body Medicine Course 2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Mind-Body Medicine and Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Biopsychomarkers [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Develop a set of biopsychomarkers to (a) identify characteristics that predict UC patient's response to Mind/Body Medicine courses and (b) establish an objective set of markers that demonstrate the impact of Mind/Body Medicine courses on well-being and UC disease state.


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mind Body Medicine Course 1
The subject of each course is Mind/Body medicine. One course is learning about the mind and the body through experiences. The other is learning about the mind and the body through experiences. Both courses will follow the same format, meeting once every week, for a total of 8 weeks, for roughly 2 hours per class. You will be provided with a schedule of the weekly classes, which will occur on the same day every week, at the same time. Weekly sessions will be run by a teacher and will include other participants in the class. . You will also be given homework assignments that are intended to reinforce what you learn in the program. The assignments will require up to 45 minutes, 6 days/week. Following the 6th class, and before the 7th class, there is a voluntary ½ day Saturday program. Participation in this program is optional. You are expected to continue to incorporate what you learned in the class in your daily routine after you are done with the classes.
Behavioral: Mind/Body Medicine Course 1
The subject of the course is Mind/Body medicine. This course is learning about the mind and the body through experiences. The course will meet once every week, for a total of 8 weeks, for roughly 2 hours per class. You will be provided with a schedule of the weekly classes, which will occur on the same day every week, at the same time. Weekly sessions will be run by a teacher and will include other participants in the class. You will also be given homework assignments that are intended to reinforce what you learn in the program. The assignments will require up to 45 minutes, 6 days/week. Following the 6th class, and before the 7th class, there is a voluntary all day Saturday program. Participation in this program is optional. You are expected to continue to incorporate what you learned in the class in your daily routine after you are done with the classes.
Active Comparator: Mind/Body Medicine Course 2
The subject of the course is Mind/Body medicine. This course is learning about the mind and the body through lectures. The course will meet once every week, for a total of 8 weeks, for roughly 2 hours per class. You will be provided with a schedule of the weekly classes, which will occur on the same day every week, at the same time. Weekly sessions will be run by a teacher and will include other participants in the class. You will also be given homework assignments that are intended to reinforce what you learn in the program. The assignments will require up to 45 minutes, 6 days/week. Following the 6th class, and before the 7th class, there is a voluntary all day Saturday program. Participation in this program is optional. You are expected to continue to incorporate what you learned in the class in your daily routine after you are done with the classes.
Behavioral: Mind/Body Medicine Course 2
The subject of the course is Mind/Body medicine. This course is learning about the mind and the body through lectures. The course will meet once every week, for a total of 8 weeks, for roughly 2 hours per class. You will be provided with a schedule of the weekly classes, which will occur on the same day every week, at the same time. Weekly sessions will be run by a teacher and will include other participants in the class. You will also be given homework assignments that are intended to reinforce what you learn in the program. The assignments will require up to 45 minutes, 6 days/week. Following the 6th class, and before the 7th class, there is a voluntary all day Saturday program. Participation in this program is optional. You are expected to continue to incorporate what you learned in the class in your daily routine after you are done with the classes.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You have been diagnosed with moderately severe Ulcerative Colitis at the time of your last flare up
  • You experienced at least one flare-up within the last year
  • Either no IBD medication or have been on a stable dose of oral 5-ASA products (i.e. Mesalamine, Sulfasalazine, or Colazol) for at least 3 weeks, immunomodulators (Imuran, 6MP, Methotrexate)for at least 3 months and biologics (TNF antibody) for at least 6 months prior to enrollment
  • If on maintenance 5-ASA products or immunomodulators and dose changes during the study, participant agrees to remain on that dose for the study duration
  • ACTIVE UC PATIENTS: If on Prednisone the dose must not be more than 20mg/day; you can be weaned off Prednisone by 5mg/day weekly to 10mg/day weekly to 2.5mg/day weekly

Exclusion Criteria:

  • Other forms of colitis, such as Clostridium Difficile Colitis or Indeterminate Colitis
  • Current use of oral steroids within the last 30 days, topical agents (i.e. steroids or 5-ASA) within the last 14 days
  • History of colon resection
  • Antibiotic use within the last 14 days
  • WOMEN: Cannot be pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491997

Contacts
Contact: Annika Gorenz, M.S. 312-942-1181 annika_gorenz@rush.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Annika Gorenz, M.S.    312-942-1181    annika_gorenz@rush.edu   
Principal Investigator: Ali Keshavarzian, MD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Ali Keshavarzian, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Ali Keshavarzian, Director, Division of Digestive Diseases, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01491997     History of Changes
Other Study ID Numbers: AT11-003 - 1 R01 AT007143-01
Study First Received: December 7, 2011
Last Updated: August 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014