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

September 23, 2020 updated by: Christane Pané-Farré, Philipps University Marburg Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in defensive activation to interoceptive threat
Time Frame: 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 from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in panic symptomatology and severity (PAS)
Time Frame: 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 from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in the severity of anxiety symptomatology (HAM-A=
Time Frame: 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 from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in anxiety sensitivity (ASI)
Time Frame: 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.
change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in agoraphobic avoidance (MI)
Time Frame: 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 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)
Time Frame: 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 from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in depression symptomatology (BDI)
Time Frame: 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 from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in Agoraphobic Cognitions (ACQ)
Time Frame: 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.
change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in fear of body symptoms (BSQ)
Time Frame: 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 from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Federal Ministry of Education and Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alfons Hamm, Ph.D., Department of Psychology, University of Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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