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, 15:357

First Online: 11 September 2014Received: 07 July 2014Accepted: 26 August 2014DOI: 10.1186-1745-6215-15-357

Cite this article as: Warschburger, P., Calvano, C., Becker, S. et al. Trials 2014 15: 357. doi:10.1186-1745-6215-15-357


BackgroundFunctional abdominal pain FAP is not only a highly prevalent disease but also poses a considerable burden on children and their families. Untreated, FAP is highly persistent until adulthood, also leading to an increased risk of psychiatric disorders. Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size, long-term follow-up data, controls and inclusion of psychosocial outcome data.

Methods-DesignIn a multicenter randomized controlled trial, 112 children aged 7 to 12 years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP n = 56 or to an active control group focusing on age-appropriate information delivery; n = 56. Randomization occurs centrally, blockwise and is stratified by center. This study is performed in five pediatric gastroenterology outpatient departments. Observer-blind assessments of outcome variables take place four times: pre-, post-, 3- and 12-months post-treatment. Primary outcome is the course of pain intensity and frequency. Secondary endpoints are health-related quality of life, pain-related coping and cognitions, as well as selfefficacy.

DiscussionThis confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP. By applying an active control group, time and attention processes can be controlled, and long-term follow-up data over the course of one year can be explored.

Trial registrationDRKS00005038 date: 25 July 2013; NCT02030392 date: 7 January 2014

KeywordsFAP Randomized controlled trial Cognitive behavioral intervention Children Pain AbbreviationsAEadverse events

CBTcognitive-behavioral therapy

CGcontrol group

FAPfunctional abdominal pain

IGintervention group

ITTintention to treat

PPAper protocol analysis

TSCtrial steering committee

T1point of measurement pre-intervention

T2point of measurement postintervention

T3point of measurement at 3-month follow-up

T4Point of measurement at 4-month follow-up

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-357 contains supplementary material, which is available to authorized users.

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Autor: Petra Warschburger - Claudia Calvano - Sebastian Becker - Michael Friedt - Christian Hudert - Carsten Posovszky - Maike Sch


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