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).
BMJ Open Gastroenterology , Volume 3 - Issue 1
Introduction: Adolescents with inflammatory bowel
disease (IBD) show a higher prevalence of depression
and anxiety, compared to youth with other chronic
diseases. The inflammation-depression hypothesis
might explain this association, and implies that treating
depression can decrease intestinal inflammation and
improve disease course. The present multicentre
randomised controlled trial aims to test the
effectiveness of an IBD-specific cognitive–behavioural
therapy (CBT) protocol in reducing symptoms of
subclinical depression and anxiety, while improving
quality of life and disease course in adolescents with
Methods and analysis: Adolescents with IBD (10– 20 years) from 7 hospitals undergo screening (online questionnaires) for symptoms of depression and anxiety. Those with elevated scores of depression (Child Depression Inventory (CDI) ≥13 or Beck Depression Inventory (BDI) II ≥14) and/or anxiety (Screen for Child Anxiety Related Disorders: boys ≥26, girls ≥30) receive a psychiatric interview. Patients meeting criteria for depressive/anxiety disorders are referred for psychotherapy outside the trial. Patients with elevated (subclinical) symptoms are randomly assigned to medical care-as-usual (CAU; n=50) or CAU plus IBD-specific CBT (n=50). Main outcomes: (1) reduction in depressive and/or anxiety symptoms after 3 months and (2) sustained remission for 12 months. Secondary outcomes: quality of life, psychosocial functioning, treatment adherence. In addition, we will assess inflammatory cytokines in peripheral blood mononuclear cells and whole blood RNA expression profiles. For analysis, multilevel linear models and generalised estimating equations will be used.
Ethics and dissemination: The Medical Ethics Committee of the Erasmus MC approved this study. If we prove that this CBT improves emotional well-being as well as disease course, implementation is recommended.
|BMJ Open Gastroenterology|
|Organisation||Department of Psychology|
van den Brink, G, Stapersma, L, El Marroun, H, Henrichs, J, Szigethy, E.M, Utens, E.M.W.J, & Escher, J.C. (2016). 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. BMJ Open Gastroenterology, 3(1). doi:10.1136/bmjgast-2015-000071