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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure-based cognitive-behavior therapy | Experimental | Patients are treated in accordance with a manualized protocol (Gloster et al., 2011) |
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| Wait-List control condition | No Intervention | Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavior therapy | Behavioral | The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfons Hamm, Ph.D. | Department of Psychology, University of Greifswald | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Greifswald | Greifswald | 17487 | Germany |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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 |