- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01323556
Mechanisms of Panic Disorders Treatment
April 8, 2011 updated by: University Medicine Greifswald
Mechanisms of CBT-Treatment Effects in Patients With Panic Disorder and Panic Disorder With Agoraphobia: The Role of Interoceptive Exposure
Investigation of mechanisms of exposure based learning by
- Investigating the effects of fear augmentation by interoceptive exposure during in vivo exposure
- Disentangling the effects of interoceptive exposure exercises in panic disorder
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
180
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alfons O Hamm, PhD
- Phone Number: +49 (0)3834-863716
- Email: hamm@uni-greifswald.de
Study Locations
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-
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Greifswald, Germany, 17489
- Recruiting
- Prof. Dr. Alfons Hamm
-
Contact:
- Alfons O. Hamm, Prof. Dr.
- Phone Number: +49 (0)3834-863716
- Email: hamm@uni-greifswald.de
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 |
---|---|
Experimental: Exposure with fear augmentation
exposure-based CBT, including interoceptive exposure and in-vivo exposure with fear augmentation by interoceptive exercises (e.g.
hyperventilation)
|
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies
|
Experimental: Exposure without fear augmentation
exposure-based CBT, including interoceptive and in-vivo exposure without fear augmentation during in-vivo exposure
|
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Anxiety Rating Scale (HARS)
Time Frame: up to 32 weeks (follow up)
|
structured clinician rating assessing the severity of an anxiety disorder
|
up to 32 weeks (follow up)
|
Clinician Global Impression Scale (CGI)
Time Frame: up to 32 weeks (follow up)
|
clinician rating assessing the severity of panic disorder and agoraphobia
|
up to 32 weeks (follow up)
|
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.
|
up to 32 weeks (follow up)
|
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.
|
up to 32 weeks (follow up)
|
Number of panic attacks
Time Frame: up to 32 weeks (follow up)
|
Number of panic attacks experienced during the last week is assessed.
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up to 32 weeks (follow up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
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
- Kunas SL, Hilbert K, Yang Y, Richter J, Hamm A, Wittmann A, Strohle A, Pfleiderer B, Herrmann MJ, Lang T, Lotze M, Deckert J, Arolt V, Wittchen HU, Straube B, Kircher T, Gerlach AL, Lueken U. The modulating impact of cigarette smoking on brain structure in panic disorder: a voxel-based morphometry study. Soc Cogn Affect Neurosci. 2020 Oct 8;15(8):849-859. doi: 10.1093/scan/nsaa103.
- Yang Y, Lueken U, Richter J, Hamm A, Wittmann A, Konrad C, Strohle A, Pfleiderer B, Herrmann MJ, Lang T, Lotze M, Deckert J, Arolt V, Wittchen HU, Straube B, Kircher T. Effect of CBT on Biased Semantic Network in Panic Disorder: A Multicenter fMRI Study Using Semantic Priming. Am J Psychiatry. 2020 Mar 1;177(3):254-264. doi: 10.1176/appi.ajp.2019.19020202. Epub 2019 Dec 16.
- Gechter J, Liebscher C, Geiger MJ, Wittmann A, Schlagenhauf F, Lueken U, Wittchen HU, Pfleiderer B, Arolt V, Kircher T, Straube B, Deckert J, Weber H, Herrmann MJ, Reif A, Domschke K, Strohle A. Association of NPSR1 gene variation and neural activity in patients with panic disorder and agoraphobia and healthy controls. Neuroimage Clin. 2019;24:102029. doi: 10.1016/j.nicl.2019.102029. Epub 2019 Oct 21.
- 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.
- Gottschalk MG, Richter J, Ziegler C, Schiele MA, Mann J, Geiger MJ, Schartner C, Homola GA, Alpers GW, Buchel C, Fehm L, Fydrich T, Gerlach AL, Gloster AT, Helbig-Lang S, Kalisch R, Kircher T, Lang T, Lonsdorf TB, Pane-Farre CA, Strohle A, Weber H, Zwanzger P, Arolt V, Romanos M, Wittchen HU, Hamm A, Pauli P, Reif A, Deckert J, Neufang S, Hofler M, Domschke K. Orexin in the anxiety spectrum: association of a HCRTR1 polymorphism with panic disorder/agoraphobia, CBT treatment response and fear-related intermediate phenotypes. Transl Psychiatry. 2019 Feb 4;9(1):75. doi: 10.1038/s41398-019-0415-8.
- Hommers LG, Richter J, Yang Y, Raab A, Baumann C, Lang K, Schiele MA, Weber H, Wittmann A, Wolf C, Alpers GW, Arolt V, Domschke K, Fehm L, Fydrich T, Gerlach A, Gloster AT, Hamm AO, Helbig-Lang S, Kircher T, Lang T, Pane-Farre CA, Pauli P, Pfleiderer B, Reif A, Romanos M, Straube B, Strohle A, Wittchen HU, Frantz S, Ertl G, Lohse MJ, Lueken U, Deckert J. A functional genetic variation of SLC6A2 repressor hsa-miR-579-3p upregulates sympathetic noradrenergic processes of fear and anxiety. Transl Psychiatry. 2018 Oct 19;8(1):226. doi: 10.1038/s41398-018-0278-4.
- Weck F, Grikscheit F, Hofling V, Kordt A, Hamm AO, Gerlach AL, Alpers GW, Arolt V, Kircher T, Pauli P, Rief W, Lang T. The role of treatment delivery factors in exposure-based cognitive behavioral therapy for panic disorder with agoraphobia. J Anxiety Disord. 2016 Aug;42:10-8. doi: 10.1016/j.janxdis.2016.05.007. Epub 2016 May 13.
- Hamm AO, Richter J, Pane-Farre C, Westphal D, Wittchen HU, Vossbeck-Elsebusch AN, Gerlach AL, Gloster AT, Strohle A, Lang T, Kircher T, Gerdes AB, Alpers GW, Reif A, Deckert J. Panic disorder with agoraphobia from a behavioral neuroscience perspective: Applying the research principles formulated by the Research Domain Criteria (RDoC) initiative. Psychophysiology. 2016 Mar;53(3):312-22. doi: 10.1111/psyp.12553.
Helpful Links
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
March 1, 2010
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
May 1, 2012
Study Registration Dates
First Submitted
March 3, 2011
First Submitted That Met QC Criteria
March 24, 2011
First Posted (Estimate)
March 25, 2011
Study Record Updates
Last Update Posted (Estimate)
April 11, 2011
Last Update Submitted That Met QC Criteria
April 8, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AH 11.2009
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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