Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder

NCT ID: NCT04366011

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: 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)

Capnometry-assisted respiratory therapy is a five-week treatment based on the theory that hyperventilation causes or maintains panic disorder.

Group Type: EXPERIMENTAL

Capnometry Assisted Respiratory Training (CART)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Methodist University

OTHER

Sponsor Role: lead

Responsible Party

Heather McClary

Director of Research Compliance

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alicia E Meuret, PhD

Role: PRINCIPAL_INVESTIGATOR

Southern Methodist University

Locations

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

Dallas, Texas, United States

Countries

United States

Other Identifiers

2011AM/AJ002

Identifier Type: -

Identifier Source: org_study_id