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

NCT01680237 | Terminated

• 1 other identifier: BoSPmA
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder With Agoraphobia

Keywords

cognitive behavior therapy; exposure in-vivo; panic disorder with agoraphobia

Outcome Measures

Primary Outcomes (1)

• Change (from baseline) in the Mobility Inventory

  Avoidance Behaviour

  0, 6, 12 month after treatment

Secondary Outcomes (1)

• Change (from baseline) in a Behavioral Approach Test

  0, 6, 12 month after treatment

Other Outcomes (1)

• Change (from baseline) in the Anxiety Disorder Interview Schedule

  0, 6, 12 month after treatment

Study Arms (2)

Cognitive behavior therapy

ACTIVE COMPARATOR

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

Exposure in-vivo

ACTIVE COMPARATOR

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

Interventions

Cognitive behavior therapy BEHAVIORAL

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.

Cognitive behavior therapy

Exposure in-vivo BEHAVIORAL

Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.

Exposure in-vivo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Zentrum für Psychotherapie

Bochum, North Rhine-Westphalia, 44787, Germany

Location

Related Publications (5)

• 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.

  PMID: 19775792 BACKGROUND

• 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.

  PMID: 18188442 BACKGROUND

• 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.

  PMID: 24451993 BACKGROUND

• 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.

  PMID: 23884863 BACKGROUND

• 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.

  PMID: 10784456 BACKGROUND

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tobias Teismann, Dr.

  Ruhr-Universität Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Tobias Teismann

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: September 7, 2012
• Study Start: October 1, 2011
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Available upon request from August 2021
• Access Criteria: Researchers in the field of anxiety disorders, meta-analysis, contact: tobias Teismann

Locations

DE (1)