Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Capnometry Assisted Respiratory Training (CART)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75206
      • Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cognitive Behavioral Therapy (CBT); 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.	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.
EXPERIMENTAL: Capnometry Assisted Respiratory Training (CART); Capnometry-assisted respiratory therapy is a five-week treatment based on the theory that hyperventilation causes or maintains panic disorder.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Panic Disorder Symptoms Severity change	Panic Disorder Severity Scale (PDSS)	During treatment (weeks 1- 12) and 2-months and 6-months follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-tidal PCO2 (carbon dioxide partial pressure) change	End-tidal PCO2	during treatment (weeks 1-12), 2 -and 6 months follow-up

Collaborators and Investigators

• Sponsor: Southern Methodist University
• Investigators: Principal Investigator: Alicia E Meuret, PhD, Southern Methodist University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (ACTUAL): April 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: 2011AM/AJ002