P1079 Mindfulness-based cognitive therapy to reduce psychological distress in patients with Inflammatory Bowel Disease: first results of a multicentre randomised controlled trial (MindIBD)

Abstract

Background: Many patients with Inflammatory Bowel Diseases (IBD) suffer from psychological distress and fatigue. Moreover they report a reduced quality of life. The availability of psychosocial treatment options is limited. As mindfulness-based cognitive therapy (MBCT) has been shown to reduce psychological distress and fatigue, and improve quality of life in other populations, MBCT might also be effective in patients with IBD. Methods: The MindIBD study was a prospective, multicentre, randomised controlled trial, conducted in one academic and three general hospitals in the Netherlands. Patients of 16 years and older with a confirmed IBD diagnosis were eligible if the IBD was in remission (based on faecal calprotectin <250 mg/kg and no changes in IBD medication for at least three months) and they experienced at least mild psychological distress (based on Hospital Anxiety and Depression Scale (HADS) total score ≥ 11). Participants were allocated in the intervention group (MBCT plus treatment as usual) or control group (treatment as usual alone). Assessments were conducted at baseline, post-intervention (3 months) and at 6, 9 and 12 months after baseline. Primary outcome was the effect on psychological distress post-intervention. Secondary outcomes included fatigue, perceived disease control, disease activity, disease-specific quality of life and positive mental health. This trial was registered at ClinicalTrials.gov: NCT04646785. Results: A total of 142 IBD patients were randomly assigned to the intervention group (n=70) or the control group (n=72). The study population had a median age of 50 years (IQR 39-59 years), consisted of 91 women (64%) and 68 participants (48%) were diagnosed with Crohn's disease. Post-intervention, participants in the intervention group showed a mean decrease on the HADS total of 4.7 ?} 6.3 points compared to a mean decrease of 1.2 ?} 5.2 points in the control group. This difference in improvement of psychological distress was statistically significant (p<0.001), and this benefit was maintained during follow-up (p=0.005). MBCT did also result in a significant improvement on fatigue (p=0.022) and positive mental health (p=0.022) post-intervention. These improvements remained in favour of the intervention group during follow-up, although not significantly different. No differences were found on perceived disease control, disease activity and disease-specific quality of life. Conclusion: MBCT reduces psychological distress and improves fatigue and positive mental health. Therefore MBCT can be considered as a valuable addition to the limited psychosocial interventions for patients with IBD to improve psychological distress, fatigue and positive mental health.