Back to resultsEffect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder
Primary Purpose
Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive-behavior therapy
Sponsored by
About this trial
This is an interventional basic science trial for Panic Disorder With Agoraphobia
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
Sites / Locations
- University of Greifswald
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exposure-based cognitive-behavior therapy
Wait-List control condition
Arm Description
Patients are treated in accordance with a manualized protocol (Gloster et al., 2011)
Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay.
Outcomes
Primary Outcome Measures
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 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 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 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.
Secondary Outcome Measures
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 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 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 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 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.
Full Information
NCT ID
NCT04568109
First Posted
September 17, 2020
Last Updated
September 23, 2020
Sponsor
Philipps University Marburg Medical Center
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT04568109
Brief Title
Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2010 (Actual)
Primary Completion Date
April 10, 2014 (Actual)
Study Completion Date
May 31, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposure-based cognitive-behavior therapy
Arm Type
Experimental
Arm Description
Patients are treated in accordance with a manualized protocol (Gloster et al., 2011)
Arm Title
Wait-List control condition
Arm Type
No Intervention
Arm Description
Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavior therapy
Intervention Description
The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises.
Primary Outcome Measure Information:
Title
Change in defensive activation to interoceptive threat
Description
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
Title
Change in panic symptomatology and severity (PAS)
Description
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
Title
Change in the severity of anxiety symptomatology (HAM-A=
Description
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
Title
Change in anxiety sensitivity (ASI)
Description
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
Secondary Outcome Measure Information:
Title
Change in agoraphobic avoidance (MI)
Description
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
Title
Change in Clinical global impression (CGI) (adapted for panic disorder symptomatology)
Description
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
Title
Change in depression symptomatology (BDI)
Description
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
Title
Change in Agoraphobic Cognitions (ACQ)
Description
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
Title
Change in fear of body symptoms (BSQ)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfons Hamm, Ph.D.
Organizational Affiliation
Department of Psychology, University of Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Greifswald
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder
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