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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Panic Disorder With Agoraphobia
- Sponsor
- Philipps University Marburg Medical Center
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Change in the severity of anxiety symptomatology (HAM-A=
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Christane Pané-Farré
Prof. Dr. Christiane Pané-Farré
Philipps University Marburg Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in the severity of anxiety symptomatology (HAM-A=
Time Frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
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 in defensive activation to interoceptive threat
Time Frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
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 in panic symptomatology and severity (PAS)
Time Frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
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 in anxiety sensitivity (ASI)
Time Frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
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.
Secondary Outcomes
- Change in agoraphobic avoidance (MI)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)
- Change in fear of body symptoms (BSQ)(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)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)
- Change in depression symptomatology (BDI)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)
- Change in Agoraphobic Cognitions (ACQ)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)