Mechanisms of Panic Disorders Treatment

Panic Disorder Clinical Trial

Official title:

Mechanisms of CBT-Treatment Effects in Patients With Panic Disorder and Panic Disorder With Agoraphobia: The Role of Interoceptive Exposure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01323556
• Other study ID #: AH 11.2009
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 3, 2011
• Last updated: April 8, 2011
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2011
• Source: University Medicine Greifswald
• Contact: Alfons O Hamm, PhD
• Phone: +49 (0)3834-863716
• Email: hamm[@]uni-greifswald.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agoraphobia
• Disease
• Panic Attacks
• Panic Disorder

Intervention

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
• Cognitive Behavioural Therapy (CBT)
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies

Locations

Country	Name	City	State
Germany	Prof. Dr. Alfons Hamm	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Rating Scale (HARS)	structured clinician rating assessing the severity of an anxiety disorder	up to 32 weeks (follow up)	No
Primary	Clinician Global Impression Scale (CGI)	clinician rating assessing the severity of panic disorder and agoraphobia	up to 32 weeks (follow up)	No
Primary	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)	No
Primary	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)	No
Primary	Number of panic attacks	Number of panic attacks experienced during the last week is assessed.	up to 32 weeks (follow up)	No

External Links

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