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

BackgroundTransdiagnostic 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.Methods/designThe 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.DiscussionThe 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.Trial registrationClinicaltrials.gov NCT02954731. Registered 25 October 2016Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-016-1175-0) contains supplementary material, which is available to authorized users.

A Critical Evaluation of the Reflective Functioning Questionnaire

“…The aim of the present research is to replicate and extend previous findings from Spitzer and colleagues, while also comprehensively presenting our concerns regarding the measure. A critical reexamination and discussion of the RFQ-8 appears to be of particular importance given that researchers are increasingly adopting the measure for primary investigations of the mentalizing construct (e.g., Agostini et al, 2019;Badoud et al, 2018;Berthelot et al, 2019;Brugnera et al, 2020;Carlone & Milan, 2020;Cosenza et al, 2019;de Meulemeester et al, 2017de Meulemeester et al, , 2018Euler et al, 2019;Gambin et al, 2020;Huang et al, 2020;Li et al, 2020;Macfie et al, 2020;Morosan et al, 2019Morosan et al, , 2020Perroud et al, 2017;Sacchetti et al, 2019;Salaminios et al, 2020;Scandurra et al, 2020) or as an outcome measure for evaluating psychotherapy effectiveness (e.g., Arnfred et al, 2017;Derks et al, 2019).…”

Social Phobia and Evasiveness: Trial Protocol for a Feasibility, Superiority, Randomized Controlled Trial of the Effect of Modified Collaborative Assessment vs. Standard Assessment on Patients’ Readiness for Psychotherapy (CO-ASSM-RCT).

“…Data from a recently finalized multicentre, randomized controlled trial [21] investigating the relative efficacy of group diagnosis-specific versus transdiagnostic cognitive-behavioral therapy for anxiety disorders or depression support the meta-analytic findings on social phobia. In this trial, 291 patients with anxiety disorders or depression received standardized treatment programs in three Danish mental health services, and the results suggested that only half of the patients no longer met diagnostic criteria for their principal diagnosis by the end of treatment [22].…”

“Despite the Differences, We Were All the Same”. Group Cohesion in Diagnosis-Specific and Transdiagnostic CBT Groups for Anxiety and Depression: A Qualitative Study

“…The current study aimed to explore the role of group cohesion in patients’ experiences of group CBT for anxiety and depression in an MHS context. Furthermore, the study set out to compare data from 12 patients who had participated in mixed-diagnoses, transdiagnostic CBT groups with the data from 11 patients who had participated in diagnosis-specific group CBT for MDD, social anxiety disorder or panic disorder/agoraphobia [ 26 ]. When discussing the results in the following sections, we define group cohesion as a feeling of belonging to the group and being mutually supported and supportive of the group.…”