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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 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: October 21, 2016
Last verified: October 2016

August 17, 2012
October 21, 2016
October 2011
December 2018   (Final data collection date for primary outcome measure)
Change (from baseline) in the Mobility Inventory [ Time Frame: 0, 6, 12 month after treatment ]
Same as current
Complete list of historical versions of study NCT01680237 on ClinicalTrials.gov Archive Site
Change (from baseline) in a Behavioral Approach Test [ Time Frame: 0, 6, 12 month after treatment ]
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).
Same as current
Change (from baseline) in the Anxiety Disorder Interview Schedule [ Time Frame: 0, 6, 12 month after treatment ]
Same as current
 
Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia
Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia
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 effects of exposure alone for patients with moderate to severe agoraphobia.

Anxiety disorders are the most common group of mental illnesses, with lifetime prevalence estimates ranging between 10-30% (Kessler et al 2007). They are an economic burden on society and the sixth largest cause of disability globally (Baxter et al 2014; Fineberg et al 2013). Suffering from an anxiety disorder is distressing, with affected individuals reporting adverse effects on quality of life comparable to sufferers of major depressive disorder, and in excess of the population norm (Mendlowicz and Stein 2000). Panic disorder with agoraphobia is especially 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 (Sanchez-Meca, Rosa-Alcazar, Marin-Martinez & Gomez-Conesa, 2010), 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 effects of exposure alone for patients with moderate to severe agoraphobia. Participants suffering from panic disorder, agoraphobia receive exposure-based treatment with elements of cognitive restructuring (CBT-group) or without such elements (Exposure-only group) delivered according to treatment manuals and in individual sessions with a maximum of 30 sessions á 50 minutes. Both treatments cover psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises. In the CBT group identification and correction of maladaptive thoughts about anxiety and its consequences is furthermore part of the treatment package.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Panic Disorder With Agoraphobia
  • Behavioral: Cognitive behavior therapy
    Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises as well as identification and correction of maladaptive thoughts about anxiety and its consequences.
  • Behavioral: Exposure in-vivo
    Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.
  • 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
    Intervention: 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

    Intervention: Behavioral: Exposure in-vivo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2020
December 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Tobias Teismann, Dr. 0049-234-3227787 tobias.teismann@rub.de
Contact: Juergen Margraf, Prof. Dr. 0049-234-3223169 juergen.margraf@rub.de
Germany
 
 
NCT01680237
BoSPmA
No
Not Provided
Yes
Data will be available upon request.
Dr. Tobias Teismann, Ruhr University of Bochum
Ruhr University of Bochum
Not Provided
Principal Investigator: Tobias Teismann, Dr. Ruhr-Universität Bochum
Ruhr University of Bochum
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP