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Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia

This study is currently recruiting participants.
Verified September 2012 by Ruhr University of Bochum
Sponsor:
Information provided by (Responsible Party):
Dr. Tobias Teismann, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01680237
First received: August 17, 2012
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  Purpose

Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety disorders. Although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research, studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences. Therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the the effects of exposure alone for patients with moderate to severe agoraphobia.


Condition Intervention Phase
Panic Disorder With Agoraphobia
 Behavioral: Cognitive behavior therapy
Behavioral: Exposure in-vivo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Change (from baseline) in the Mobility Inventory [ Time Frame: 0, 6, 12 month after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change (from baseline) in a Behavioral Approach Test [ Time Frame: 0, 6, 12 month after treatment ] [ Designated as safety issue: No ]
    Participants are asked to go up a high and narrow church tower. The test yields number of floors (0-10) the patient achieves, recording the experienced anxiety level (0-100).


Other Outcome Measures:
  • Change (from baseline) in the Anxiety Disorder Interview Schedule [ Time Frame: 0, 6, 12 month after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive behavior therapy
  1. Identification of bodily sensations, cognitions and safety behaviors characteristic of the individual patient
  2. Modification of dysfunctional beliefs and assumptions using socratic questioning and behavioral experiments
  3. Exposure in-vivo
  4. Relapse prevention
 Behavioral: Cognitive behavior therapy
Active Comparator: Exposure in-vivo
  1. Preparation of a brief behavior analysis of the individual case and construction of a hierarchy of relevant (internal and external) phobic situations
  2. Exposure with internal stimuli
  3. Exposure with external stimuli
  4. Relapse prevention

Remark: In this condition there is no active work with the patient`s catastrophic cognitions

 Behavioral: Exposure in-vivo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of panic disorder with agoraphobia by trained clinician using a structured interview
  • The anxiety disorder is considered to be the patient`s main current problem
  • Age between 18 and 65 years
  • The patient has agreed to participate in the study

Exclusion Criteria:

- Diagnosis of bipolar disorder, psychotic disorder, alcohol/substance abuse or dependency (within past 3 months), prominent risk of self-harm, organic mental disorder; concurrent psychotherapeutic or psychopharmacological treatment

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680237

Contacts
Contact: Tobias Teismann, Dr. 0049-234-3227787 tobias.teismann@rub.de
Contact: Juergen Margraf, Prof. Dr. 0049-234-3223169 juergen.margraf@rub.de

Locations
Germany
Zentrum für Psychotherapie Recruiting
Bochum, NRW, Germany, 44787
Contact: Tobias Teismann, Dr.     0049-234-3227787     tobias.teismann@rub.de    
Principal Investigator: Tobias Teismann, Dr.            
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Tobias Teismann, Dr. Ruhr-Universität Bochum
  More Information

No publications provided

Responsible Party: Dr. Tobias Teismann, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01680237     History of Changes
Other Study ID Numbers: BoSPmA
Study First Received: August 17, 2012
Last Updated: September 3, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
cognitive behavior therapy
exposure in-vivo
panic disorder with agoraphobia

Additional relevant MeSH terms:
Agoraphobia
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013