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

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• 作者：Maria Kleinstä ; uber^a ; ^{maria.kleinstaeuber@staff.uni-marburg.de" class="auth_mail" title="E-mail the corresponding author} ; Japhia Gottschalk^a ; ^{Gottschj@staff.uni-marburg.de" class="auth_mail" title="E-mail the corresponding author} ; Matthias Berking^b ; ^{matthias.berking@fau.de" class="auth_mail" title="E-mail the corresponding author} ; Jö ; rn Rau^c ; ^{joern.rau@kks.uni-marburg.de" class="auth_mail" title="E-mail the corresponding author} ; Winfried Rief^a ; ^{riefw@staff.uni-marburg.de" class="auth_mail" title="E-mail the corresponding author}
• 关键词：BDI-II ; Beck Depression Inventory II ; CBT ; cognitive behavior therapy ; CCT ; Coordinating Center for Clinical Trials ; CEQ ; Credibility/Expectancy Questionnaire ; DSMB ; Data Safety and Monitoring Board ; eCRF ; electronic case report form ; DSM-IV/&minus ;   ; 5 ; Diagnostic and Statistical Manual of Mental Disorders 4th/5th Revision ; ENCERT ; Enriching Cognitive Behavior Therapy with Emotion Regulation Training for Patients with Multiple Medically Unexplained Symptoms ; EQ-5D ; EuroQuol-5D ; ERSQ ; Emotion
• 刊名：Contemporary Clinical Trials
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：47
• 期：Complete
• 页码：54-63
• 全文大小：652 K

文摘

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