Clinical Trial: Mechanisms of Panic Disorders Treatment

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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

Detailed Summary: 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.
Sponsor: University Medicine Greifswald

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Medicine Greifswald

Dates:
Date Received: March 3, 2011
Date Started: March 2010
Date Completion: May 2012
Last Updated: April 8, 2011
Last Verified: March 2011