Mechanisms of Panic Disorders Treatment

Sponsor

University Medicine Greifswald (Other)

Overall Status

Unknown status

CT.gov ID

NCT01323556

Collaborator

German Federal Ministry of Education and Research (Other)

180

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Panic Disorder Agoraphobia Panic Attacks	Behavioral: Cognitive Behavioural Therapy (CBT) 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

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2010

Anticipated Primary Completion Date :

Oct 1, 2011

Anticipated Study Completion Date :

May 1, 2012

Arms and Interventions

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

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

Primary Outcome Measures

Hamilton Anxiety Rating Scale (HARS) [up to 32 weeks (follow up)]
structured clinician rating assessing the severity of an anxiety disorder
Clinician Global Impression Scale (CGI) [up to 32 weeks (follow up)]
clinician rating assessing the severity of panic disorder and agoraphobia
Panic and Agoraphobia Scale (PAS) [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.
Mobility Inventory [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.
Number of panic attacks [up to 32 weeks (follow up)]
Number of panic attacks experienced during the last week is assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof. Dr. Alfons Hamm	Greifswald		Germany	17489

Sponsors and Collaborators

University Medicine Greifswald
German Federal Ministry of Education and Research

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