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

Introduction: 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 and design: 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. Discussion: 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. Trial registration: NCT01908855 (C) 2015 Elsevier Inc All rights reserved.