title: Stop the pain: study protocol for a randomized-controlled trial.
abstract: BACKGROUND
  Functional 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
  In 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 self-efficacy.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  DRKS00005038 (date: 25 July 2013); NCT02030392 (date: 7 January 2014).
authors.affiliation: Department Psychology, Counseling Psychology, University of Potsdam, Karl-Liebknecht-Straße 24-25, Potsdam 14476, Germany. warschb@uni-potsdam.de.
authors.forename: Petra
authors.initials: P
authors.lastname: Warschburger
authors.forename: Claudia
authors.initials: C
authors.lastname: Calvano
authors.forename: Sebastian
authors.initials: S
authors.lastname: Becker
authors.forename: Michael
authors.initials: M
authors.lastname: Friedt
authors.forename: Christian
authors.initials: C
authors.lastname: Hudert
authors.forename: Carsten
authors.initials: C
authors.lastname: Posovszky
authors.forename: Maike
authors.initials: M
authors.lastname: Schier
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
mesh_terms: D015746:Abdominal Pain / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D000223:Adaptation, Psychological; D000367:Age Factors; D002648:Child; D002652:Child Behavior; D002985:Clinical Protocols; D003071:Cognition; D015928:Cognitive Behavioral Therapy; D005260:Female; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D020377:Self Efficacy; D013997:Time Factors; D016896:Treatment Outcome