Clinical trial NCT01491997: Mind-Body Medicine and Ulcerative Colitis
Official title: Mind-Body Medicine and Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2011-12-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Statistical Analysis. The investigator will use the biopsychomarkers identified as the highest prediction value to determine the relative accuracy to predict response to the Mindful Intervention (i.e., disease outcome). For response to the mindful intervention, the investigator will use the use the combination of markers to study whether they correctly predict the response to the intervention. The investigator will study the accuracy of the markers using area under the curve (AUC) summary index for ROC curves.181 If the classification accuracy of the markers is high then the area under the curve will be close to 1. If the predictive accuracy of the combined set of markers were poor then the (AUC) will be close to 0.5.

Power Estimates UC disease flare-up was quite common in this sample, occurring in well over half of subjects in the samples collected in the discovery phase. The power analyses, assuming α = 0.05 for all tests indicated that for models involving analyses of correlational data, there will be sufficient power at even small effect sizes for the smallest possible sample with full data across all data points and virtually all variables. For the most conservative estimate, the investigator base their calculations on having 50 participants with data with full integrity. With an effect size of r = 0.15 and n = 50, power is 80 or greater to detect effect sizes of r = 0.20. Effect sizes below this threshold would likely not be clinically significant or substantively interpretable, as they would explain less than 2% in the variance of the dependent variable. Thus, most effect sizes that would be reasonably and substantially interpretable will have good power. Each factor that is suspected of varying between groups can be examined with the chi-square test based on 1 degrees of freedom, by setting it invariant in one model and then allowing it to be freely estimated in the other. Such a chi-square test provides a power of 0.80 with effect size difference of 0.15.

For binary categorical measures, such as responsiveness to MSRB, the investigator conducted separate power analyses.

The power for adjusted analyses of primary predictors of interest will be evaluated as a function of the risk of outcome when all ancillary variables are set to their mean value, the predictor is set to the mean value, and proportion of variance in predictor explained by the ancillary variables, and the odds ratio of outcome variable from increasing the predictor by an amount equal to one of its standard deviation. The range in probabilities of outcome variables can be anywhere from 20% for less likely events and 50% for more likely events, the investigator will provide power calculations over a wide range of probabilities. The investigator believe that the amount of variation of our typical model ranges from about 20% to 50%. The table (below) represents the minimum odds ratio than can be detected with 80% power, which indicate good power for expected outcome.

Proportions R2 =.20 R2=.50 0.10 1.64 1.87 0.20 1.46 1.63 0.30 1.39 1.53 0.40 1.35 1.48 0.50 1.32 1.43

Eligibility 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

Primary outcomes:
measure: Biopsychomarkers
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Ali Keshavarzian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.