NCT01323556

Brief Summary

Investigation of mechanisms of exposure based learning by

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 11, 2011

Status Verified

March 1, 2011

Enrollment Period

1.6 years

First QC Date

March 3, 2011

Last Update Submit

April 8, 2011

Conditions

Panic DisorderAgoraphobiaPanic Attacks

Keywords

Panic disorderagoraphobiapanic attacksexposure based learninginteroceptive exposure exercisesfear augmentationin vivo exposure

Outcome Measures

Primary Outcomes (5)

  • Hamilton Anxiety Rating Scale (HARS)

    structured clinician rating assessing the severity of an anxiety disorder

    up to 32 weeks (follow up)

  • Clinician Global Impression Scale (CGI)

    clinician rating assessing the severity of panic disorder and agoraphobia

    up to 32 weeks (follow up)

  • 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.

    up to 32 weeks (follow up)

  • 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.

    up to 32 weeks (follow up)

  • Number of panic attacks

    Number of panic attacks experienced during the last week is assessed.

    up to 32 weeks (follow up)

Study Arms (2)

Exposure with fear augmentation

EXPERIMENTAL

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

Behavioral: Cognitive Behavioural Therapy (CBT)

Exposure without fear augmentation

EXPERIMENTAL

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

Behavioral: Cognitive Behavioural Therapy (CBT)

Interventions

Cognitive Behavioural Therapy (CBT)BEHAVIORAL

12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure

Exposure with fear augmentation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Alfons Hamm

Greifswald, 17489, Germany

RECRUITING

Related Publications (8)

  • 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.

    PMID: 32734299DERIVED

  • 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.

    PMID: 31838872DERIVED

  • 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.

    PMID: 31734525DERIVED

  • 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.

    PMID: 31712720DERIVED

  • 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.

    PMID: 30718541DERIVED

  • 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.

    PMID: 30341278DERIVED

  • 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.

    PMID: 27235836DERIVED

  • 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.

    PMID: 26877119DERIVED

Related Links

MeSH Terms

Conditions

Panic DisorderAgoraphobia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alfons O. Hamm, Prof. Dr.

    Institute for Psychology Ernst-Moritz-Arndt-University Greifswald Franz-Mehring-Str. 47; 17487 Greifswald, Germany

    PRINCIPAL INVESTIGATOR

  • Thomas Lang, Dr.

    Center for Clinical Psychology and Rehabilitation/ Christoph-Dornier-Foundation for Clinical Psychology University Bremen Grazer Str. 2b 28359 Bremen, Germany

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Central Study Contacts

Alfons O Hamm, PhD

CONTACT

+49 (0)3834-863716hamm@uni-greifswald.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 25, 2011

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

May 1, 2012

Last Updated

April 11, 2011

Record last verified: 2011-03

Locations

DE(1)