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

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

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder With Agoraphobia; Panic Disorder Without Agoraphobia
• Intervention / Treatment: Behavioral: Cognitive-behavior therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17487
    • University of Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure-based cognitive-behavior therapy; Patients are treated in accordance with a manualized protocol (Gloster et al., 2011)	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.
No Intervention: Wait-List control condition; Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Alfons Hamm, Ph.D., Department of Psychology, University of Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): April 10, 2014
• Study Completion (Actual): May 31, 2014

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Anxiety Disorders; Disease; Panic Disorder; Agoraphobia
• Other Study ID Numbers: PA_CBT_HV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No