Mind-Body Medicine and Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

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
    

Intervention name(s): Mind/Body Medicine Course 1; Mind/Body Medicine Course 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care