The effectiveness of cognitive behavioral therapy on the quality of life of patients with inflammatory bowel disease: multi-center design and study protocol (KL!C- study)

BACKGROUND: Inflammatory Bowel Disease (IBD) patients report poorer quality of life (QoL) and more anxiety and depressive symptoms than controls from the general population. Cognitive behavioral therapy (CBT) is effective for anxiety and depression, but questionable in case of co-morbidity with IBD. Therefore, an adapted new CBT specifically designed for IBD patients was developed. The objective of this study is to evaluate the effectiveness of adapted CBT on QoL. METHODS/DESIGN: IBD patients with a poor level of mental QoL (score less than or equal to 23 on the mental health scale of SF-36) will be randomly assigned to the experimental (n = 40) or waiting-list control condition (n = 40). The experimental condition will then immediately start CBT. The waiting-list control condition will wait 3,5 months before CBT begins with pre- and post assessments. Both conditions will complete a baseline and follow-up assessment following CBT and a mid-treatment assessment. The primary outcome is IBD-specific QoL (IBDQ). Secondary outcomes are generic QoL (SF-36) and anxiety and depression complaints (HADS, CES-D). Additionally, we will examine the working mechanism of the psychological intervention by investigating the impact of the intervention on illness-related cognitions, attitudes, coping styles and their associations with outcome. Data will be analysed on an intention to treat (ITT) as well as treatment completer basis (greater than or equal to five sessions followed). DISCUSSION: If found effective, this IBD-specific CBT is a first step to enhance poor QoL in IBD patients and possibly, other gastroenterological diseases. By enhancing IBD patients’ QoL, we may also improve their mental and physical health, and lower unnecessary health care consumption. TRIAL REGISTRATION NUMBER: NTR (TC = 1869)