Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder

Not Applicable

Completed

• Conditions: Panic Disorder
• Interventions: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Capnometry Assisted Respiratory Training (CART)

• Registration Number: NCT04366011
• Lead Sponsor: Southern Methodist University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-05-13
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy (CBT)	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.
Capnometry Assisted Respiratory Training (CART)	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.

Primary Outcome Measures

Name	Time	Method
Panic Disorder Symptoms Severity change	During treatment (weeks 1- 12) and 2-months and 6-months follow-ups	Panic Disorder Severity Scale (PDSS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University; 🇺🇸 Dallas, Texas, United States