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

Primary Purpose

Panic Disorder With Agoraphobia

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive behavior therapy
Exposure in-vivo
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder With Agoraphobia focused on measuring cognitive behavior therapy, exposure in-vivo, panic disorder with agoraphobia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zentrum für PsychotherapieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive behavior therapy

Exposure in-vivo

Arm Description

Identification of bodily sensations, cognitions and safety behaviors characteristic of the individual patient Modification of dysfunctional beliefs and assumptions using socratic questioning and behavioral experiments Exposure in-vivo Relapse prevention

Preparation of a brief behavior analysis of the individual case and construction of a hierarchy of relevant (internal and external) phobic situations Exposure with internal stimuli Exposure with external stimuli Relapse prevention Remark: In this condition there is no active work with the patient's catastrophic cognitions

Outcomes

Primary Outcome Measures

Change (from baseline) in the Mobility Inventory
Avoidance Behaviour

Secondary Outcome Measures

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).

Full Information

First Posted
August 17, 2012
Last Updated
October 31, 2022
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT01680237
Brief Title
Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia
Official Title
Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder With Agoraphobia
Keywords
cognitive behavior therapy, exposure in-vivo, panic disorder with agoraphobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavior therapy
Arm Type
Active Comparator
Arm Description
Identification of bodily sensations, cognitions and safety behaviors characteristic of the individual patient Modification of dysfunctional beliefs and assumptions using socratic questioning and behavioral experiments Exposure in-vivo Relapse prevention
Arm Title
Exposure in-vivo
Arm Type
Active Comparator
Arm Description
Preparation of a brief behavior analysis of the individual case and construction of a hierarchy of relevant (internal and external) phobic situations Exposure with internal stimuli Exposure with external stimuli Relapse prevention Remark: In this condition there is no active work with the patient's catastrophic cognitions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure in-vivo
Intervention Description
Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.
Primary Outcome Measure Information:
Title
Change (from baseline) in the Mobility Inventory
Description
Avoidance Behaviour
Time Frame
0, 6, 12 month after treatment
Secondary Outcome Measure Information:
Title
Change (from baseline) in a Behavioral Approach Test
Description
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
Other Pre-specified Outcome Measures:
Title
Change (from baseline) in the Anxiety Disorder Interview Schedule
Description
Remission Status
Time Frame
0, 6, 12 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Teismann, Dr.
Phone
0049-234-3227787
Email
tobias.teismann@rub.de
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Margraf, Prof. Dr.
Phone
0049-234-3223169
Email
juergen.margraf@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Teismann, Dr.
Organizational Affiliation
Ruhr-Universität Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Psychotherapie
City
Bochum
State/Province
NRW
ZIP/Postal Code
44787
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Teismann, Dr.
Phone
0049-234-3227787
Email
tobias.teismann@rub.de
First Name & Middle Initial & Last Name & Degree
Tobias Teismann, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
19775792
Citation
Sanchez-Meca J, Rosa-Alcazar AI, Marin-Martinez F, Gomez-Conesa A. Psychological treatment of panic disorder with or without agoraphobia: a meta-analysis. Clin Psychol Rev. 2010 Feb;30(1):37-50. doi: 10.1016/j.cpr.2009.08.011. Erratum In: Clin Psychol Rev. 2010 Aug;30(6):815-7.
Results Reference
background
PubMed Identifier
18188442
Citation
Kessler RC, Angermeyer M, Anthony JC, DE Graaf R, Demyttenaere K, Gasquet I, DE Girolamo G, Gluzman S, Gureje O, Haro JM, Kawakami N, Karam A, Levinson D, Medina Mora ME, Oakley Browne MA, Posada-Villa J, Stein DJ, Adley Tsang CH, Aguilar-Gaxiola S, Alonso J, Lee S, Heeringa S, Pennell BE, Berglund P, Gruber MJ, Petukhova M, Chatterji S, Ustun TB. Lifetime prevalence and age-of-onset distributions of mental disorders in the World Health Organization's World Mental Health Survey Initiative. World Psychiatry. 2007 Oct;6(3):168-76.
Results Reference
background
PubMed Identifier
24451993
Citation
Baxter AJ, Vos T, Scott KM, Ferrari AJ, Whiteford HA. The global burden of anxiety disorders in 2010. Psychol Med. 2014 Aug;44(11):2363-74. doi: 10.1017/S0033291713003243. Epub 2014 Jan 22.
Results Reference
background
PubMed Identifier
23884863
Citation
Fineberg NA, Haddad PM, Carpenter L, Gannon B, Sharpe R, Young AH, Joyce E, Rowe J, Wellsted D, Nutt DJ, Sahakian BJ. The size, burden and cost of disorders of the brain in the UK. J Psychopharmacol. 2013 Sep;27(9):761-70. doi: 10.1177/0269881113495118. Epub 2013 Jul 24.
Results Reference
background
PubMed Identifier
10784456
Citation
Mendlowicz MV, Stein MB. Quality of life in individuals with anxiety disorders. Am J Psychiatry. 2000 May;157(5):669-82. doi: 10.1176/appi.ajp.157.5.669.
Results Reference
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Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia

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