Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder

NCT04366011 | Completed

• 1 other identifier: 2011AM/AJ002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (1)

• Panic Disorder Symptoms Severity change

  Panic Disorder Severity Scale (PDSS)

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

Secondary Outcomes (1)

• End-tidal PCO2 (carbon dioxide partial pressure) change

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

Study Arms (2)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

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)

Capnometry Assisted Respiratory Training (CART)

EXPERIMENTAL

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)

Interventions

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.

Cognitive Behavioral Therapy (CBT)

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.

Capnometry Assisted Respiratory Training (CART)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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)
• 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

Sponsors & Collaborators

• Southern Methodist University: lead

Study Sites (1)

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

Dallas, Texas, 75206, United States

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alicia E Meuret, PhD

  Southern Methodist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Compliance

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: April 28, 2020
• Study Start: November 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

US (1)