Panic Disorder Clinical Trial
Official title:
Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder: A Pragmatic, Multicenter Non-inferiority Randomized Controlled Trial
Transdiagnostic Cognitive Behavior Therapy (CBT) delivered in the individual format, have
been proven just as effective as traditional diagnosis specific CBT manuals. The
investigators have translated and modified the "The Unified Protocol for Transdiagnostic
Treatment of Emotional Disorders" (UP-CBT) to make it applicable as group therapy in Danish
Mental Health Service and a naturalistic trial of this manual has shown promising results. As
the use of one manual instead of several diagnosis specific manuals in regional clinics could
simplify logistics and reduce waiting time, the investigators want to compare group UP-CBT
with diagnosis specific group CBT.
Method: A partial blinded, pragmatic, non-inferiority, multicentre randomized clinical trial
(RCT). UP-CBT is compared to treatment-as-usual CT. 124 patients are included in each
intervention arm, recruited from three Danish regional Mental Health Service Clinics. 31st
July 2018 suppl: Inclusion number expanded to 170 in each arm due to unexpected large
drop-out.
Background: Transdiagnostic Cognitive Behavior Therapy (TCBT) Manuals delivered in individual
format, have been reported to be just as effective as traditional diagnosis specific CBT
manuals. The investigators have translated and modified the "The Unified Protocol for
Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) developed by Barlow and colleagues
for use in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a
naturalistic trial. 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, the study aim to test the relative efficacy of group UP-CBT and
diagnosis specific group CBT.
Methods/design: It is a partially blinded, pragmatic, non-inferiority, parallel, multi-center
randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for depression, social
anxiety disorder and agoraphobia/panic disorder. In both arms, the intervention consists of
weekly group session for 14 weeks. In total, 248 patients are recruited from three regional
MHS centers across the country and included in two intervention arms.31st July 2018 suppl:
Inclusion number expanded to 340 due to unexpected large drop-out.
Outcomes are measured at end of therapy and at 6 months follow-up. Weekly patient-rated
outcomes and group evaluations are collected for every session. Outcome assessors, blind to
delivered intervention, will perform the observer-based symptom ratings, and fidelity
assessors will monitor manual adherence.
Discussion: The current study will be the first RCT investigating the dissemination of the UP
in a MHS setting and UP delivered in groups and including patients with depression. 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.
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