Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia
Conditions
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.
Interventions
BEHAVIORALCognitive-behavior therapy
The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises.
Sponsors
German Federal Ministry of Education and Research
Philipps University Marburg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed