Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder

Panic Disorder Clinical Trial

Official title:

Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366011
• Other study ID #: 2011AM/AJ002
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: October 2015

Study information

• Verified date: April 2020
• Source: Southern Methodist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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

2. 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:

1. 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

2. 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

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT)
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.
• Capnometry Assisted Respiratory Training (CART)
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.

Locations

Country	Name	City	State
United States	Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Panic Disorder Symptoms Severity change	Panic Disorder Severity Scale (PDSS)	During treatment (weeks 1- 12) and 2-months and 6-months follow-ups
Secondary	End-tidal PCO2 (carbon dioxide partial pressure) change	End-tidal PCO2	during treatment (weeks 1-12), 2 -and 6 months follow-up