Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder
- Conditions
- Panic Disorder Without AgoraphobiaPanic Disorder With Agoraphobia
- Interventions
- Behavioral: Cognitive-behavior therapy
- Registration Number
- NCT04568109
- Lead Sponsor
- Philipps University Marburg Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exposure-based cognitive-behavior therapy Cognitive-behavior therapy Patients are treated in accordance with a manualized protocol (Gloster et al., 2011)
- Primary Outcome Measures
Name Time Method Change in the severity of anxiety symptomatology (HAM-A= 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 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) 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) 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 Outcome Measures
Name Time Method Change in agoraphobic avoidance (MI) change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period 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 in fear of body symptoms (BSQ) change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period 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 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 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 in depression symptomatology (BDI) change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period Beck Depression Inventory (BDI) measures depressive symptomatology (self-report measure). Total score range: 0 to 63. Higher scores indicate worse depressive symptomatology.
Change in Agoraphobic Cognitions (ACQ) change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period Agoraphobic Cognitions Questionnaire (ACQ) is a self-report measure assessing agoraphobic cognitions. Total score range: 1 to 5. Higher scores indicate worse agoraphobic cognitions.
Trial Locations
- Locations (1)
University of Greifswald
🇩🇪Greifswald, Germany
University of Greifswald🇩🇪Greifswald, Germany