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Clinical Trials/NCT01680237
NCT01680237
Terminated
Not Applicable

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

Ruhr University of Bochum1 site in 1 country130 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Panic Disorder With Agoraphobia
Sponsor
Ruhr University of Bochum
Enrollment
130
Locations
1
Primary Endpoint
Change (from baseline) in the Mobility Inventory
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
November 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ruhr University of Bochum
Responsible Party
Principal Investigator
Principal Investigator

Dr. Tobias Teismann

Dr. Tobias Teismann

Ruhr University of Bochum

Eligibility 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

Outcomes

Primary Outcomes

Change (from baseline) in the Mobility Inventory

Time Frame: 0, 6, 12 month after treatment

Avoidance Behaviour

Secondary Outcomes

  • Change (from baseline) in a Behavioral Approach Test(0, 6, 12 month after treatment)

Study Sites (1)

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