Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder

Panic Disorder With Agoraphobia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568109
• Other study ID #: PA_CBT_HV
• Status: Completed
• Phase: N/A
• Start date: February 1, 2010
• Est. completion date: May 31, 2014

Study information

• Verified date: September 2020
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 31, 2014
• Est. primary completion date: April 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Disease
• Panic Disorder
• Panic Disorder With Agoraphobia
• Panic Disorder Without Agoraphobia

Intervention

Behavioral:
• Cognitive-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.

Locations

Country	Name	City	State
Germany	University of Greifswald	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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.	change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Secondary	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
Secondary	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
Secondary	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