Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder

Study Overview
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Brief Summary
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The present study aims to investigate a potential mechanism of successful CBT for panic disorder, i.e., the reduction of excessive anxious apprehension and fear responses to panic-related body symptoms in the context of CBT treatment. In the present non-randomized interventional study, effects of cognitive behavior therapy on reported symptoms and fear responses to panic-related body symptoms are investigated. It is expected that symptom improvement during CBT is associated with a decrease in the activation of the brain's fear network to panic-related body symptoms.

Detailed Description
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Changes in fear responses to body symptoms in the course of CBT are investigated in patients with PD by applying a highly standardized hyperventilation task (provoking panic-related body symptoms) prior to and after a manualized CBT or a waiting period. Activation of the brain's fear network (defensive activation) is indexed by the potentiation of the startle eyeblink response.

Official Title
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Effect of Cognitive-behavior Therapy on Panic Symptomatology and the Activation of the Brain's Fear Network to Panic-related Body Symptoms in Patients With Panic Disorder

Conditions
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Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia

Intervention / Treatment
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* Behavioral: Cognitive-behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current primary diagnosis of panic disorder (with or without agoraphobia) as defined by the criteria of the diagnostic and statistical manual, fourth revision/text revision (DSM-IV-TR) (determined using the Composite International Diagnostic Interview and verified by a certified psychotherapist) age 18 - 65 years Exclusion Criteria: current suicidal intent any psychotic or bipolar disorder borderline personality disorder a medical condition that could explain patients' symptoms physical contradictions regarding application of exposure-based CBT (e.g., neurological disease) Patients has to be on a stable psychopharmacological medication schedule prior to study entry for at least 12 weeks Intake of benzodiazepines

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure-based cognitive-behavior therapy<br>Patients are treated in accordance with a manualized protocol (Gloster et al., 2011) | Behavioral: Cognitive-behavior therapy<br>* The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises.<br>|
| No Intervention: Wait-List control condition<br>Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in defensive activation to interoceptive threat | Defensive activation to interoceptive threat (induced via a standardized hyperventilation task) is assessed using the startle eyeblink response (measured via electromyographic activity over the left musculus orbicularis oculi) to an acoustic startle probe. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period | 
| Change in panic symptomatology and severity (PAS) | The Panic and Agoraphobia Scale (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. Total score range: 0 to 57. Higher scores indicate worse severity of panic symptomatology. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period | 
| Change in the severity of anxiety symptomatology (HAM-A= | The Hamilton Anxiety Rating Scale (HAM-A) is a structured clinician rating assessing the severity of anxiety symptomatology. Total score rage: 0 to 56. Higher scores indicate worse severity of anxiety symptomatology. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period | 
| Change in anxiety sensitivity (ASI) | The Anxiety Sensitivity Index (ASI) is a self-report measure of fear of anxiety-related body symptoms (i.e., anxiety sensitivity). Total score range: 0 to 64. Higher scores indicate worse anxiety sensitivity. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in agoraphobic avoidance (MI) | Mobility inventory (MI) is a self-report measure that assess agoraphobic avoidance. Total score range: 1 to 5. Higher scores indicate worse agoraphobic avoidance. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period | 
| Change in Clinical global impression (CGI) (adapted for panic disorder symptomatology) | Clinical global impression scale (CGI) is a clinician rated global panic disorder severity measure. Total score range: 1 to 7. Higher scores indicate worse global panic disorder severity. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period | 
| Change in depression symptomatology (BDI) | Beck Depression Inventory (BDI) measures depressive symptomatology (self-report measure). Total score range: 0 to 63. Higher scores indicate worse depressive symptomatology. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period | 
| Change in Agoraphobic Cognitions (ACQ) | Agoraphobic Cognitions Questionnaire (ACQ) is a self-report measure assessing agoraphobic cognitions. Total score range: 1 to 5. Higher scores indicate worse agoraphobic cognitions. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period | 
| Change in fear of body symptoms (BSQ) | Self reported fear of body symptoms is measured using the Body Sensation Questionnaire (BSQ). Total score range: 17 to 85. Higher scores indicate worse fear of anxiety sen. | change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period |