Effectiveness of disease-specific cognitive–behavioural therapy on depression, anxiety, quality of life and the clinical course of disease in adolescents with inflammatory bowel disease: study protocol of a multicentre randomised controlled trial (HAPPY-IBD)

摘要: Introduction Adolescents with inflammatory bowel disease (IBD) show a higher prevalence of depression and anxiety, compared to youth other chronic diseases. The inflammation-depression hypothesis might explain this association, implies that treating can decrease intestinal inflammation improve course. present multicentre randomised controlled trial aims test the effectiveness an IBD-specific cognitive–behavioural therapy (CBT) protocol in reducing symptoms subclinical while improving quality life course adolescents IBD. Methods analysis IBD (10–20 years) from 7 hospitals undergo screening (online questionnaires) for anxiety. Those elevated scores (Child Depression Inventory (CDI) ≥13 or Beck (BDI) II ≥14) and/or anxiety (Screen Child Anxiety Related Disorders: boys ≥26, girls ≥30) receive psychiatric interview. Patients meeting criteria depressive/anxiety disorders are referred psychotherapy outside trial. (subclinical) randomly assigned medical care-as-usual (CAU; n=50) CAU plus CBT (n=50). Main outcomes: (1) reduction depressive after 3 months (2) sustained remission 12 months. Secondary life, psychosocial functioning, treatment adherence. In addition, we will assess cytokines peripheral blood mononuclear cells whole RNA expression profiles. For analysis, multilevel linear models generalised estimating equations be used. Ethics dissemination Medical Committee Erasmus MC approved study. If prove improves emotional well-being as well course, implementation is recommended. Trial registration number NCT02265588.