An interventional study of Cognitive behavior therapy and Exposure in-vivo in Panic Disorder With Agoraphobia, sponsored by Ruhr University of Bochum. Terminated at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Ruhr University of Bochum · Not applicable, Interventional, and Treatment
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.
65 studies on the registry are indexed under Agoraphobia; 12 are open to participants now.
This study's enrollment of 130 is above the median of 78 across 61 interventional studies indexed under Agoraphobia.
Browse Agoraphobia studies →Ruhr University of Bochum is the lead sponsor of 126 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
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
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.
Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.
Change (from baseline) in the Mobility Inventory
Avoidance Behaviour
Time frame: 0, 6, 12 month after treatment
Change (from baseline) in a Behavioral Approach Test
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).
Time frame: 0, 6, 12 month after treatment
Change (from baseline) in the Anxiety Disorder Interview Schedule
Remission Status
Time frame: 0, 6, 12 month after treatment
Plan to share: Yes — Data will be available upon request.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: Available upon request from August 2021
Access criteria: Researchers in the field of anxiety disorders, meta-analysis, contact: tobias Teismann
This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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