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Open Access Study protocol

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)

Floor Bennebroek Evertsz’1*, Claudi LH Bockting2, Pieter CF Stokkers3, Chris Hinnen45, Robbert Sanderman4 and Mirjam AG Sprangers1

Author Affiliations

1 Department of Medical Psychology, Academic Medical Center, Meibergdreef 15, 1105 AZ, Amsterdam, the Netherlands

2 Department of Clinical Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS, Groningen, the Netherlands

3 Department of Gastroenterology, Sint Lucas Andreas Hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, the Netherlands

4 Health Psychology Section, Department of Health Sciences, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 1 9713 AV, Groningen, the Netherlands

5 Department of Medical Psychology, Slotervaart Hospital, Louwesweg 6, 1066 EC, Amsterdam, the Netherlands

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BMC Psychiatry 2012, 12:227  doi:10.1186/1471-244X-12-227

Published: 14 December 2012

Abstract

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)

Keywords:
Inflammatory Bowel Disease; Cognitive behavioral therapy; Quality of life; Anxiety; Depression