Mechanisms of Panic Disorders Treatment

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Panic Disorder, Agoraphobia, Panic Attacks

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy (CBT)
* Behavioral: Cognitive Behavioural Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure with fear augmentation<br>exposure-based CBT, including interoceptive exposure and in-vivo exposure with fear augmentation by interoceptive exercises (e.g. hyperventilation) | Behavioral: Cognitive Behavioural Therapy (CBT)<br>* 12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure<br>|
| Experimental: Exposure without fear augmentation<br>exposure-based CBT, including interoceptive and in-vivo exposure without fear augmentation during in-vivo exposure | Behavioral: Cognitive Behavioural Therapy (CBT)<br>* 12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panic disorder, agoraphobia, panic attacks, exposure based learning, interoceptive exposure exercises, fear augmentation, in vivo exposure