Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder
Condition: Depression, Unipolar; Anxiety Disorder Social; Panic Disorder
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders; Panic Disorder; Agoraphobia; Phobia, Social
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): UP-CBT; Standard-CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy; Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavior Therapy; Negative Affect; Unified Protocol; Session Tracking; Mechanisms of Change in Psychotherapy