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Mechanisms of Panic Disorders Treatment

Primary Purpose

Panic Disorder, Agoraphobia, Panic Attacks

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy (CBT)
Cognitive Behavioural Therapy (CBT)
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Panic disorder, agoraphobia, panic attacks, exposure based learning, interoceptive exposure exercises, fear augmentation, in vivo exposure

Eligibility Criteria

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

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

Sites / Locations

  • Prof. Dr. Alfons HammRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exposure with fear augmentation

Exposure without fear augmentation

Arm Description

exposure-based CBT, including interoceptive exposure and in-vivo exposure with fear augmentation by interoceptive exercises (e.g. hyperventilation)

exposure-based CBT, including interoceptive and in-vivo exposure without fear augmentation during in-vivo exposure

Outcomes

Primary Outcome Measures

Hamilton Anxiety Rating Scale (HARS)
structured clinician rating assessing the severity of an anxiety disorder
Clinician Global Impression Scale (CGI)
clinician rating assessing the severity of panic disorder and agoraphobia
Panic and Agoraphobia Scale (PAS)
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.
Mobility Inventory
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.
Number of panic attacks
Number of panic attacks experienced during the last week is assessed.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2011
Last Updated
April 8, 2011
Sponsor
University Medicine Greifswald
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01323556
Brief Title
Mechanisms of Panic Disorders Treatment
Official Title
Mechanisms of CBT-Treatment Effects in Patients With Panic Disorder and Panic Disorder With Agoraphobia: The Role of Interoceptive Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Medicine Greifswald
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Agoraphobia, Panic Attacks
Keywords
Panic disorder, agoraphobia, panic attacks, exposure based learning, interoceptive exposure exercises, fear augmentation, in vivo exposure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure with fear augmentation
Arm Type
Experimental
Arm Description
exposure-based CBT, including interoceptive exposure and in-vivo exposure with fear augmentation by interoceptive exercises (e.g. hyperventilation)
Arm Title
Exposure without fear augmentation
Arm Type
Experimental
Arm Description
exposure-based CBT, including interoceptive and in-vivo exposure without fear augmentation during in-vivo exposure
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Intervention Description
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Intervention Description
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale (HARS)
Description
structured clinician rating assessing the severity of an anxiety disorder
Time Frame
up to 32 weeks (follow up)
Title
Clinician Global Impression Scale (CGI)
Description
clinician rating assessing the severity of panic disorder and agoraphobia
Time Frame
up to 32 weeks (follow up)
Title
Panic and Agoraphobia Scale (PAS)
Description
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.
Time Frame
up to 32 weeks (follow up)
Title
Mobility Inventory
Description
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.
Time Frame
up to 32 weeks (follow up)
Title
Number of panic attacks
Description
Number of panic attacks experienced during the last week is assessed.
Time Frame
up to 32 weeks (follow up)

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alfons O Hamm, PhD
Phone
+49 (0)3834-863716
Email
hamm@uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfons O. Hamm, Prof. Dr.
Organizational Affiliation
Institute for Psychology Ernst-Moritz-Arndt-University Greifswald Franz-Mehring-Str. 47; 17487 Greifswald, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Lang, Dr.
Organizational Affiliation
Center for Clinical Psychology and Rehabilitation/ Christoph-Dornier-Foundation for Clinical Psychology University Bremen Grazer Str. 2b 28359 Bremen, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexander L. Gerlach, Prof. Dr.
Organizational Affiliation
Institute for Clinical Psychology and Psychotherapy WWU Münster Fliednerstr. 21 48149 Münster, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tilo Kirchner, Prof. Dr.
Organizational Affiliation
Department of Psychiatry und Psychotherapy Philipps-University Marburg Rudolf-Bultmann- Straße 8 35039 Marburg, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Georg W. Alpers, Prof. Dr.
Organizational Affiliation
Institute for Biological Psychology, Clinical Psychology and Psychotherapy University Würzburg Marcusstrasse 9-11 97070 Würzburg, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Prof. Dr. Alfons Hamm
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfons O. Hamm, Prof. Dr.
Phone
+49 (0)3834-863716
Email
hamm@uni-greifswald.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
32734299
Citation
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.
Results Reference
derived
PubMed Identifier
31838872
Citation
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.
Results Reference
derived
PubMed Identifier
31734525
Citation
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.
Results Reference
derived
PubMed Identifier
31712720
Citation
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.
Results Reference
derived
PubMed Identifier
30718541
Citation
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.
Results Reference
derived
PubMed Identifier
30341278
Citation
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.
Results Reference
derived
PubMed Identifier
27235836
Citation
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.
Results Reference
derived
PubMed Identifier
26877119
Citation
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.
Results Reference
derived
Links:
URL
http://www.paniknetz.de/
Description
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