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Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder

NCT02954731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2020-09-16

No results posted yet for this study

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.

Conditions

  • Depression, Unipolar
  • Anxiety Disorder Social
  • Panic Disorder

Interventions

BEHAVIORAL

UP-CBT

Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy

BEHAVIORAL

Standard-CBT

Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Psychiatric Research Unit, Region Zealand, Denmark

    lead OTHER

Principal Investigators

  • Sidse MH Arnfred, MD,PhD,DMSc · Universityhospital Copenhagen, Psychiatry West, Mental Health Services Region Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-04-11
Completion
2019-12-11

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954731 on ClinicalTrials.gov