Mechanisms of Panic Disorders Treatment

Phase 2

• Conditions: Panic Disorder; Agoraphobia; Panic Attacks
• Interventions: Behavioral: Cognitive Behavioural Therapy (CBT)

• Registration Number: NCT01323556
• Lead Sponsor: University Medicine Greifswald

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 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 Timeline

• Study Start: 2010-03
• Status Verified: 2011-03
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-11
• Primary Completion: 2011-10
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposure with fear augmentation	Cognitive Behavioural Therapy (CBT)	exposure-based CBT, including interoceptive exposure and in-vivo exposure with fear augmentation by interoceptive exercises (e.g. hyperventilation)
Exposure without fear augmentation	Cognitive Behavioural Therapy (CBT)	exposure-based CBT, including interoceptive and in-vivo exposure without fear augmentation during in-vivo exposure

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Prof. Dr. Alfons Hamm; 🇩🇪 Greifswald, Germany