Mind-Body Medicine and Ulcerative Colitis

NCT01491997 | Completed DMC

• 1 other identifier: AT11-003 - 1 R01 AT007143-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Biopsychomarkers

  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.

  4 years

Study Arms (2)

Mind Body Medicine Course 1

ACTIVE COMPARATOR

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

Mind/Body Medicine Course 2

ACTIVE COMPARATOR

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

Interventions

Mind/Body Medicine Course 1 BEHAVIORAL

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.

Mind Body Medicine Course 1

Mind/Body Medicine Course 2 BEHAVIORAL

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.

Mind/Body Medicine Course 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Jedel S, Beck T, Swanson G, Hood MM, Voigt RM, Gorenz A, Jakate S, Raeisi S, Hobfoll S, Keshavarzian A. Mindfulness Intervention Decreases Frequency and Severity of Flares in Inactive Ulcerative Colitis Patients: Results of a Phase II, Randomized, Placebo-Controlled Trial. Inflamm Bowel Dis. 2022 Dec 1;28(12):1872-1892. doi: 10.1093/ibd/izac036.

  PMID: 35661212 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ali Keshavarzian, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Digestive Diseases

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 14, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

US (1)