OBJECTIVES: Crohn's disease (CD) significantly impairs patients' Health Related Quality of Life (HRQoL) affecting physical, emotional and social domains. We examined whether a tailored Mindfulness-based cognitive intervention (MBCI) can improve HRQoL in adult CD patients. METHODS: Adult patients (≥18 years) with active CD (HBI in range of 5-16) attending for routine follow-up at a teaching hospital were enrolled consecutively and randomized to either Intervention (MBCI) or Control groups. MBCI was delivered in 8 weekly one-hour sessions by trained therapists on-line via SKYPE application; daily practice was monitored. Patients' HRQoL and utility weights were assessed using EQ-5D-3L and SF-12 at two time points: at study entry and after 3 months follow-up. RESULTS: The preliminary analysis included a cohort of 41 patients: 20 in the MBCI and 21 in the Control group. Patients’ mean (SD) age was 36 (14.4) and 34 (10.8), mean (SD) disease duration was 9.7 years (10.1) and 9.7 years (8.9), mean HBI was 9.1 and 8.5, for the Intervention and Control groups, respectively. Both utility scores significantly improved over 3 months of follow-up in the MBCI group while showing decrease or slight increase in the Control group. EQ-5D-3L utility index increased by 0.11 in the MBCI group (p<0.01) vs 0.03 in Controls (p=0.54). EQ VAS increased from 54.4 to 62.6 in the MBCI group (p=0.09) while decreased from 55.5 to 50 in the Controls (p=0.39). SF-12 Mental Health Composite increased by 2.9 points in the MBCI group (p=0.03) vs 2.5 decrease in Controls (p=0.15). SF-12 Physical Health Composite increased by 7.3 in the MBCI group (p<0.01) vs 2.5 increase in Controls (p=0.17). CONCLUSIONS: An interim analysis of this RCT demonstrated a trend for improved HRQoL following MBCI intervention. The full study results involving 200 patients could likely demonstrate a clinically and statistically significant improvement in HRQoL in adult CD patients receiving MBCI.