Back to resultsEfficacy and Mechanisms of Psychosocial Treatments for Panic Disorder
Primary Purpose
Panic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Capnometry Assisted Respiratory Training (CART)
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility Criteria
Inclusion Criteria:
- A current DSM-IV (Diagnostic and Statistical Manual IV) diagnosis of panic disorder with or without agoraphobia that is designated by the patient as the most important source of current distress
- Patients must be willing to engage in exposure to fearful situations and sensations.
Exclusion Criteria:
Diagnostic Exclusion Criteria:
1) A history of bipolar disorder, psychosis or delusional disorders (as evaluated by the SCID-IV-L (Structured Clinical Interview for the DSM IV) screening questions), substance abuse or dependence or alcohol abuse or dependence (other than nicotine in the last 3 months)
Medical exclusion factors:
- Patients with severe unstable medical illness, clinically significant laboratory findings, or serious medical illness for which hospitalization may be likely within the next three months
- Patients with a history of seizures, angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, transient ischemic attacks, cerebrovascular accidents, diabetes mellitus, significant asthma, emphysema, or chronic obstructive pulmonary disease
Sites / Locations
- Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cognitive Behavioral Therapy (CBT)
Capnometry Assisted Respiratory Training (CART)
Arm Description
Cognitive Behavioral Therapy is a twelve-week therapeutic intervention based on the theory that maladaptive thoughts contribute to symptom development and maintenance of PD/A.
Capnometry-assisted respiratory therapy is a five-week treatment based on the theory that hyperventilation causes or maintains panic disorder.
Outcomes
Primary Outcome Measures
Panic Disorder Symptoms Severity change
Panic Disorder Severity Scale (PDSS)
Secondary Outcome Measures
End-tidal PCO2 (carbon dioxide partial pressure) change
End-tidal PCO2
Full Information
NCT ID
NCT04366011
First Posted
May 13, 2013
Last Updated
April 27, 2020
Sponsor
Southern Methodist University
1. Study Identification
Unique Protocol Identification Number
NCT04366011
Brief Title
Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder
Official Title
Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Methodist University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study is to a) determine the comparative efficacy of the brief capnometry-assisted respiratory therapy (CART) and standard cognitive behavioural therapy (CBT), and b) to determine moderators and mediators.
With the data collected from the study, the investigators will test the following hypotheses: (a) CART will be as effective in treating PD/A as CBT, albeit in shorter time, b) patients with greater respiratory dysregulations, especially hyperventilation, at pretreatment will benefit more from CART, whereas patients with greater cognitive dysregulation will benefit more from CBT. CART, but not CBT, will result in reversal of hyperventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy is a twelve-week therapeutic intervention based on the theory that maladaptive thoughts contribute to symptom development and maintenance of PD/A.
Arm Title
Capnometry Assisted Respiratory Training (CART)
Arm Type
Experimental
Arm Description
Capnometry-assisted respiratory therapy is a five-week treatment based on the theory that hyperventilation causes or maintains panic disorder.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
CBT teaches a set of cognitive and somatic coping skills to manage panic and anxiety as patients conduct repeated exposure to feared situations and sensations.
Intervention Type
Behavioral
Intervention Name(s)
Capnometry Assisted Respiratory Training (CART)
Intervention Description
CART has four major treatment components: educating patients about the etiology and maintenance of PD according to a hyperventilation centered rationale, directing patients' attention to potentially aberrant respiratory patterns, instructing patients in respiratory control techniques, and instructing patients in home breathing exercises.
Primary Outcome Measure Information:
Title
Panic Disorder Symptoms Severity change
Description
Panic Disorder Severity Scale (PDSS)
Time Frame
During treatment (weeks 1- 12) and 2-months and 6-months follow-ups
Secondary Outcome Measure Information:
Title
End-tidal PCO2 (carbon dioxide partial pressure) change
Description
End-tidal PCO2
Time Frame
during treatment (weeks 1-12), 2 -and 6 months follow-up
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:
A current DSM-IV (Diagnostic and Statistical Manual IV) diagnosis of panic disorder with or without agoraphobia that is designated by the patient as the most important source of current distress
Patients must be willing to engage in exposure to fearful situations and sensations.
Exclusion Criteria:
Diagnostic Exclusion Criteria:
1) A history of bipolar disorder, psychosis or delusional disorders (as evaluated by the SCID-IV-L (Structured Clinical Interview for the DSM IV) screening questions), substance abuse or dependence or alcohol abuse or dependence (other than nicotine in the last 3 months)
Medical exclusion factors:
Patients with severe unstable medical illness, clinically significant laboratory findings, or serious medical illness for which hospitalization may be likely within the next three months
Patients with a history of seizures, angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, transient ischemic attacks, cerebrovascular accidents, diabetes mellitus, significant asthma, emphysema, or chronic obstructive pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia E Meuret, PhD
Organizational Affiliation
Southern Methodist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
12. IPD Sharing Statement
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Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder
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