title: Enriching Cognitive Behavior Therapy with Emotion Regulation Training for Patients with Multiple Medically Unexplained Symptoms (ENCERT): Design and implementation of a multicenter, randomized, active-controlled trial.
abstract: BACKGROUND
  Although cognitive behavior therapy (CBT) is the best evidenced psychological treatment for medically unexplained symptoms (MUS), effect sizes are rather moderate. Empirically evidenced deficits in emotion processing in patients with MUS make a CBT enriched with an emotion regulation training (ENCERT) a promising approach to increase treatment effects.
  
  
  METHODS
  This protocol describes the development and implementation of a multicenter, randomized, active-controlled study with blinded outcome assessors to compare the efficacy of ENCERT with a conventional CBT for MUS. Individuals presenting with ≥3 disabling, chronic MUS and fulfilling other predefined inclusion criteria are randomized to 20 sessions either of ENCERT or conventional CBT. Power calculations are based on the severity index of the Screening of Somatoform Disorders-7T and obtained an optimal sample size of N=244. Questionnaires on symptom severity, symptom-related psychological features, and emotion regulation skills are administered at baseline, end of therapy, and 6-months follow-up. An every-session monitoring of therapy progress, and regular patients'/therapists' ratings of quality of therapy, working alliance, outcome expectations, and adverse events are conducted. Primary statistical analysis shall verify the hypothesis of ENCERT being more efficacious than conventional CBT regarding symptom severity.
  
  
  CONCLUSIONS
  Enriching CBT with transdiagnostic therapeutic strategies addressing emotion regulation is a promising and new approach to target not only somatic symptom coping but also symptom-associated problems and comorbid mental disorders. The current trial will not only allow examining the efficacy of ENCERT but also important variables and mechanisms of the process of therapy.
  
  
  BACKGROUND
  NCT01908855.
authors.affiliation: Department of Clinical Psychology and Psychotherapy, Philipps-University, Gutenbergstr. 18, 35032 Marburg, Germany. Electronic address: maria.kleinstaeuber@staff.uni-marburg.de.
authors.forename: Maria
authors.initials: M
authors.lastname: Kleinstäuber
authors.affiliation: Department of Clinical Psychology and Psychotherapy, Philipps-University, Gutenbergstr. 18, 35032 Marburg, Germany. Electronic address: Gottschj@staff.uni-marburg.de.
authors.forename: Japhia
authors.initials: J
authors.lastname: Gottschalk
authors.affiliation: Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-University, Nägelsbachstr. 25a, 91052 Erlangen-Nuremberg, Germany. Electronic address: matthias.berking@fau.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Berking
authors.affiliation: Coordinating Center for Clinical Trials, Philipps-University, Karl-von-Frisch-Str. 4, 35043 Marburg, Germany. Electronic address: joern.rau@kks.uni-marburg.de.
authors.forename: Jörn
authors.initials: J
authors.lastname: Rau
authors.affiliation: Department of Clinical Psychology and Psychotherapy, Philipps-University, Gutenbergstr. 18, 35032 Marburg, Germany. Electronic address: riefw@staff.uni-marburg.de.
authors.forename: Winfried
authors.initials: W
authors.lastname: Rief
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D004644:Emotions; D006801:Humans; D000071896:Medically Unexplained Symptoms; D008875:Middle Aged; D000068356:Self-Control; D016037:Single-Blind Method; D013001:Somatoform Disorders / Q000523:psychology / Q000534:rehabilitation*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Active-controlled trial; Cognitive behavior therapy; Emotion regulation; Medically unexplained symptoms; Multicenter trial; Randomized controlled trial