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

NCT ID: NCT04568109

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-01
• Study Completion Date: 2014-05-31

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.

Conditions

Panic Disorder With Agoraphobia; Panic Disorder Without Agoraphobia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Exposure-based cognitive-behavior therapy

Patients are treated in accordance with a manualized protocol (Gloster et al., 2011)

Group Type: EXPERIMENTAL

Cognitive-behavior therapy

Intervention Type: 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.

Wait-List control condition

Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Christane Pané-Farré

Prof. Dr. Christiane Pané-Farré

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfons Hamm, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, University of Greifswald

Locations

University of Greifswald

Greifswald, , Germany

Countries

Germany

Other Identifiers

PA_CBT_HV

Identifier Type: -

Identifier Source: org_study_id