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

April 9, 2024 updated by: Dr. Tobias Teismann, Ruhr University of Bochum
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44787
        • Zentrum für Psychotherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change (from baseline) in the Mobility Inventory
Time Frame: 0, 6, 12 month after treatment
Avoidance Behaviour
0, 6, 12 month after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0, 6, 12 month after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change (from baseline) in the Anxiety Disorder Interview Schedule
Time Frame: 0, 6, 12 month after treatment
Remission Status
0, 6, 12 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Tobias Teismann, Dr., Ruhr-Universität Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimated)

September 7, 2012

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BoSPmA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon request.

IPD Sharing Time Frame

Available upon request from August 2021

IPD Sharing Access Criteria

Researchers in the field of anxiety disorders, meta-analysis, contact: tobias Teismann

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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