RANDOMIZED CONTROLLED TRIAL OF COGNITIVE BEHAVIORAL MINDFULNESS INTERVENTION IN CROHN'S DISEASE PATIENTS: EFFECTS ON PSYCHOLOGICAL MEASURES AND PERIPHERAL BLOOD HORMONES AND CYTOKINES

Introduction Crohn’s Disease (CD) patients have reduced quality-of-life since they experience more psychological stress than healthy persons. We examined whether a short-term program of Cognitive Behavioral Mindfulness Intervention (hereinafter "Intervention") would produce psychological benefits that are associated with changes in inflammation- and stress-related peripheral blood hormone and cytokine levels. Methods Adult CD with Harvey-Bradshaw
Index of disease severity (HBI) in range 5−15 were randomized prospectively into 2 groups, Intervention and Control. Cognitive Behavioral Mindfulness Intervention was taught to the Intervention group weekly over 3 months by social workers, using a standardized protocol, by SkypeTM. Control group patients were wait-listed. Patients' quality-of-life was assessed by the disease-specific Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and the generic Short Form 12 Physical Health and Mental Health Questionnaire (SF12PH, SF12MH).
Biological measures of inflammation/stress included cortisol, IL-10 and TNF α. Data were obtained at baseline (T1) and at 3 months (T2), and were analyzed by Chi-square, MannWhitney, t-test, and Spearman rho correlation. Patient medication was at the discretion of treating physicians. Results Patient characteristics at T1 were as follows. Intervention group:
n=23, mean age 31.4±9.2 y, 70% female, 48% on biologicals, 22% on immunomodulators; Control group: n=25, 31.8±9.4 y, 56%, 40%, 20%, respectively (p=ns). Comparing T1 and T2, disease activity by HBI decreased more in the Intervention group than the Control group, while quality-of-life increased in Intervention group by SIBDQ, and in both groups by SF12PH (Table 1). While the changes between T1 and T2 in levels of cortisol, IL-10 and TNFα in both groups did not reach statistical significance, the negative associations of
relative DTNFα with relative DSIBDQ (r = -.39, p<.05), DSF12PH (r = -.54, p<.01), and DSF12MH (r = -.26, p=.02) were all significant in the Intervention group, but none was significant in the Control group. The association of DHBI with DIL-10 (r = .42, p<.05) was significant in the Intervention group. Finally, there was a significant positive association of DHBI with Dcortisol (r = .43, p=.04) in the Control group between T1 and T2. Conclusions Cognitive Behavioral Mindfulness Intervention was associated with a decrease of disease
activity, improved quality-of-life, decreased level of pro-inflammatory cytokine TNF α, and reduced level of the anti-inflammatory cytokine IL-10 in the Intervention group. The positive correlation of DHBI with Dcortisol between T1 and T2 seems to indicate an ongoing stress reaction in persons not receiving Cognitive Behavioral Mindfulness Intervention. Confirmation in a larger cohort is required.