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Mechanisms of Panic Disorders Treatment

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ClinicalTrials.gov Identifier: NCT01323556
Recruitment Status : Unknown
Verified March 2011 by University Medicine Greifswald.
Recruitment status was:  Recruiting
First Posted : March 25, 2011
Last Update Posted : April 11, 2011
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University Medicine Greifswald

Study Description
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Brief Summary:

Investigation of mechanisms of exposure based learning by

  1. Investigating the effects of fear augmentation by interoceptive exposure during in vivo exposure
  2. Disentangling the effects of interoceptive exposure exercises in panic disorder

Condition or disease Intervention/treatment Phase
Panic Disorder Agoraphobia Panic Attacks Behavioral: Cognitive Behavioural Therapy (CBT) Phase 2 Phase 3

Detailed Description:
The study aims on investigating the effect of fear augmentation during in-vivo exposure by adding interoceptive exposure (e.g., hyperventilation) in PD/AG patients. By comparing the fear augmentation group with the therapist-guided CBT exposure, and by measuring autonomic arousal during and between exposure sessions, it will be possible to study the mechanisms of exposure based learning. A second aim is to disentangle effects of specific interoceptive exposure exercises (e.g., respiratory vs. vestibular stimulation). Finally, by including patients without agoraphobic avoidance it will be possible to investigate whether interoceptive exposure alone will have any effect. This might open the door for early interventions for individuals after experiencing an initial panic attack to prevent the development of a severe panic disorder with agoraphobic avoidance.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms of CBT-Treatment Effects in Patients With Panic Disorder and Panic Disorder With Agoraphobia: The Role of Interoceptive Exposure
Study Start Date : March 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : May 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Exposure with fear augmentation
exposure-based CBT, including interoceptive exposure and in-vivo exposure with fear augmentation by interoceptive exercises (e.g. hyperventilation)
 Behavioral: Cognitive Behavioural Therapy (CBT)
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure
Experimental: Exposure without fear augmentation
exposure-based CBT, including interoceptive and in-vivo exposure without fear augmentation during in-vivo exposure
 Behavioral: Cognitive Behavioural Therapy (CBT)
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Anxiety Rating Scale (HARS) [ Time Frame: up to 32 weeks (follow up) ]
    structured clinician rating assessing the severity of an anxiety disorder

  2. Clinician Global Impression Scale (CGI) [ Time Frame: up to 32 weeks (follow up) ]
    clinician rating assessing the severity of panic disorder and agoraphobia

  3. Panic and Agoraphobia Scale (PAS) [ Time Frame: up to 32 weeks (follow up) ]
    PAS is self-rating assessing panic disorder and agoraphobia severity with five factor analytic derived subscale scores (panic attacks, anticipatory anxiety, agoraphobic avoidance, health concerns, functional impairment) and a total score indicating the global severity. The questionnaire was specifically developed for monitoring changes during psychotherapy or psychopharmacological treatments.

  4. Mobility Inventory [ Time Frame: up to 32 weeks (follow up) ]
    Self-rating assessing the extent of situational avoidance. The questionnaire comprises 27 situations that have to be evaluated in regard to frequency of avoidance, when alone or when accompanied.

  5. Number of panic attacks [ Time Frame: up to 32 weeks (follow up) ]
    Number of panic attacks experienced during the last week is assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years old
  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of panic disorder, panic disorder with agoraphobia OR initial panic attacks
  • CGI ≥ 4 (except persons with initial panic attacks)
  • Informed Consent

Exclusion Criteria:

  • Acute suicidality
  • Current substance use disorder
  • Lifetime diagnosis of psychotic disorders, bipolar disorders, borderline personality disorders
  • Severe medical condition (chronic conditions)
  • Current psychotherapeutic or psychopharmacological treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323556


Contacts
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Contact: Alfons O Hamm, PhD +49 (0)3834-863716 hamm@uni-greifswald.de

Locations
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Germany
Prof. Dr. Alfons Hamm Recruiting
Greifswald, Germany, 17489
Contact: Alfons O. Hamm, Prof. Dr.    +49 (0)3834-863716    hamm@uni-greifswald.de   
Sponsors and Collaborators
University Medicine Greifswald
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Alfons O. Hamm, Prof. Dr. Institute for Psychology Ernst-Moritz-Arndt-University Greifswald Franz-Mehring-Str. 47; 17487 Greifswald, Germany
Study Director: Thomas Lang, Dr. Center for Clinical Psychology and Rehabilitation/ Christoph-Dornier-Foundation for Clinical Psychology University Bremen Grazer Str. 2b 28359 Bremen, Germany
Study Chair: Alexander L. Gerlach, Prof. Dr. Institute for Clinical Psychology and Psychotherapy WWU Münster Fliednerstr. 21 48149 Münster, Germany
Study Chair: Tilo Kirchner, Prof. Dr. Department of Psychiatry und Psychotherapy Philipps-University Marburg Rudolf-Bultmann- Straße 8 35039 Marburg, Germany
Study Chair: Georg W. Alpers, Prof. Dr. Institute for Biological Psychology, Clinical Psychology and Psychotherapy University Würzburg Marcusstrasse 9-11 97070 Würzburg, Germany
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Forstner AJ, Awasthi S, Wolf C, Maron E, Erhardt A, Czamara D, Eriksson E, Lavebratt C, Allgulander C, Friedrich N, Becker J, Hecker J, Rambau S, Conrad R, Geiser F, McMahon FJ, Moebus S, Hess T, Buerfent BC, Hoffmann P, Herms S, Heilmann-Heimbach S, Kockum I, Olsson T, Alfredsson L, Weber H, Alpers GW, Arolt V, Fehm L, Fydrich T, Gerlach AL, Hamm A, Kircher T, Pane-Farre CA, Pauli P, Rief W, Strohle A, Plag J, Lang T, Wittchen HU, Mattheisen M, Meier S, Metspalu A, Domschke K, Reif A, Hovatta I, Lindefors N, Andersson E, Schalling M, Mbarek H, Milaneschi Y, de Geus EJC, Boomsma DI, Penninx BWJH, Thorgeirsson TE, Steinberg S, Stefansson K, Stefansson H, Muller-Myhsok B, Hansen TF, Borglum AD, Werge T, Mortensen PB, Nordentoft M, Hougaard DM, Hultman CM, Sullivan PF, Nothen MM, Woldbye DPD, Mors O, Binder EB, Ruck C, Ripke S, Deckert J, Schumacher J. Genome-wide association study of panic disorder reveals genetic overlap with neuroticism and depression. Mol Psychiatry. 2021 Aug;26(8):4179-4190. doi: 10.1038/s41380-019-0590-2. Epub 2019 Nov 11.

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Responsible Party: Prof. Dr. A. Hamm, University of Greifswald, Department of Clinical Psychology
ClinicalTrials.gov Identifier: NCT01323556    
Other Study ID Numbers: AH 11.2009
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: March 2011
Keywords provided by University Medicine Greifswald:
Panic disorder
agoraphobia
panic attacks
exposure based learning
 interoceptive exposure exercises
fear augmentation
in vivo exposure
Additional relevant MeSH terms:
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Panic Disorder
Agoraphobia
Anxiety Disorders
Mental Disorders
Phobic Disorders