Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia
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|ClinicalTrials.gov Identifier: NCT01680237|
Recruitment Status : Recruiting
First Posted : September 7, 2012
Last Update Posted : October 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Panic Disorder With Agoraphobia||Behavioral: Cognitive behavior therapy Behavioral: Exposure in-vivo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Cognitive behavior therapy
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.
Active Comparator: Exposure in-vivo
Remark: In this condition there is no active work with the patient`s catastrophic cognitions
Behavioral: Exposure in-vivo
Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.
- Change (from baseline) in the Mobility Inventory [ Time Frame: 0, 6, 12 month after treatment ]
- 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).
- Change (from baseline) in the Anxiety Disorder Interview Schedule [ Time Frame: 0, 6, 12 month after treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680237
|Contact: Tobias Teismann, Dr.||firstname.lastname@example.org|
|Contact: Juergen Margraf, Prof. Dr.||email@example.com|
|Zentrum für Psychotherapie||Recruiting|
|Bochum, NRW, Germany, 44787|
|Contact: Tobias Teismann, Dr. 0049-234-3227787 firstname.lastname@example.org|
|Principal Investigator: Tobias Teismann, Dr.|
|Principal Investigator:||Tobias Teismann, Dr.||Ruhr-Universität Bochum|