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Completed

NCT Number: NCT04366011

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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University

Dallas, Texas, 75206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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)

Behavioral

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 outcomes

  1. Panic Disorder Symptoms Severity change

    Time frame: During treatment (weeks 1- 12) and 2-months and 6-months follow-ups

    Panic Disorder Severity Scale (PDSS)

Secondary outcomes

  1. End-tidal PCO2 (carbon dioxide partial pressure) change

    Time frame: during treatment (weeks 1-12), 2 -and 6 months follow-up

    End-tidal PCO2

Sponsors and collaborators

Lead sponsor

Southern Methodist University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2020
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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