title: Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial.
abstract: Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT.
  
  
  
  The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence.
  
  
  
  The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect.
  
  
  
  Clinicaltrials.gov NCT02954731 . Registered 25 October 2016.
authors.affiliation: Psychiatric Hospital Slagelse & Psychiatric Research Unit, Region Zealand Psychiatry, Faelledvej 6, Building 3, Level 4., DK-4200, Slagelse, Denmark. sidar@regionsjaelland.dk.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark. sidar@regionsjaelland.dk.
authors.forename: Sidse M
authors.initials: SM
authors.lastname: Arnfred
authors.affiliation: Psychotherapeutic Clinic Nannasgade, Mental Health Centre Copenhagen, Capital Region Mental Health Services, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Ruth
authors.initials: R
authors.lastname: Aharoni
authors.affiliation: Psychiatric Hospital Slagelse & Psychiatric Research Unit, Region Zealand Psychiatry, Faelledvej 6, Building 3, Level 4., DK-4200, Slagelse, Denmark.
authors.forename: Morten
authors.initials: M
authors.lastname: Hvenegaard
authors.affiliation: Department of Psychology, Faculty of Social Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Stig
authors.initials: S
authors.lastname: Poulsen
authors.affiliation: Psychiatric Hospital Slagelse & Psychiatric Research Unit, Region Zealand Psychiatry, Faelledvej 6, Building 3, Level 4., DK-4200, Slagelse, Denmark.
authors.forename: Bo
authors.initials: B
authors.lastname: Bach
authors.affiliation: Unit for Anxiety and Compulsive Disorders, Psychiatric Hospital Risskov, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Mikkel
authors.initials: M
authors.lastname: Arendt
authors.affiliation: Psychotherapeutic Clinic Nannasgade, Mental Health Centre Copenhagen, Capital Region Mental Health Services, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Nicole K
authors.initials: NK
authors.lastname: Rosenberg
authors.affiliation: Psychotherapeutic Clinic Nannasgade, Mental Health Centre Copenhagen, Capital Region Mental Health Services, Copenhagen University Hospital, Copenhagen, Denmark.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Nina
authors.initials: N
authors.lastname: Reinholt
mesh_terms: D000328:Adult; D000379:Agoraphobia / Q000628:therapy*; D001008:Anxiety Disorders / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003865:Major Depressive Disorder / Q000628:therapy*; D004644:Emotions; D005260:Female; D006801:Humans; D008297:Male; D016584:Panic Disorder / Q000628:therapy*; D010349:Patient Compliance; D011615:Psychotherapy, Group; D016037:Single-Blind Method; D016896:Treatment Outcome
keywords: Anxiety; Change Mechanisms; Clinical Trial; Cognitive Behavior Therapy; Depression; Negative Affect; Session Tracking; Unified Protocol