An interventional study of Cognitive-behavior therapy in Panic Disorder With Agoraphobia and Panic Disorder Without Agoraphobia, sponsored by Philipps University Marburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-29.
Sponsored by Philipps University Marburg · Not applicable, Interventional, and Basic science
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.
65 studies on the registry are indexed under Agoraphobia; 12 are open to participants now.
This study's enrollment of 58 is below the median of 78 across 61 interventional studies indexed under Agoraphobia.
Browse Agoraphobia studies →Philipps University Marburg is the lead sponsor of 116 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are treated in accordance with a manualized protocol (Gloster et al., 2011)
Behavioral: Cognitive-behavior therapy
Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay.
The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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