Mechanisms of Treatment Change in Panic Disorder and Agoraphobia

Moderators and Mediators of Treatment Change in Panic Disorder and Agoraphobia

The primary goal of the present study is to identify mechanisms of therapeutic change of two theoretically contrasting therapeutic procedures: The first phase consists of comparing the outcome of the capnometry-assisted breathing therapy (BRT) with cognitive restructuring (CT). During the second phase participants of both interventions will undergo in-vivo exposure.

Study Overview

• Status: Completed
• Conditions: Panic Disorder With Agoraphobia
• Intervention / Treatment: Behavioral: Cognitive Therapy; Behavioral: Capnometry-Assisted Respiratory Training; Behavioral: In-vivo exposure

Detailed Description

The primary goal of the present study is to identify mechanisms of therapeutic change of two theoretically contrasting therapeutic procedures: While the rationale of breathing training is based on the assumption that hypocapnea (lower than normal levels of pCO2) is responsible for the development and maintenance of panic disorder, the rationale of cognitive interventions is that the primary mechanism in PD is the cognitive misinterpretation of benign bodily sensations. Further, while breathing training should induce a low-anxiety state (through parasympathetic activation) and, therefore, facilitate habituation to fearful situations, voluntary increases in arousal through hyperventilation (sympathetic activation) has been suggested to facilitate cognitive restructuring during exposure.

In order to study mechanisms that potentially produce clinical improvement, the investigators propose a 2-phase therapeutic intervention: The first phase consists of comparing the outcome of the capnometry-assisted respiratory training (CART) with cognitive restructuring (CT). During the second phase participants of both interventions will undergo in-vivo exposure therapy.

With the data collected from the study, the investigators will test the following hypotheses: (a) CART will produce more reduction in psycho-physiologically relevant measures of panic symptoms compared to CT, while cognitive restructuring will produce more reduction in cognitive parameters of panic symptoms; (b) CART will influence the response to voluntary hyperventilation tests by leading to faster recovery compared to CT. Improvement in respiratory psychophysiology will be correlated with improvement in panic symptom severity; (c) Breathing techniques during exposure will lead to a lower-anxiety state, facilitating but not inhibiting fear extinction as suggested by the safety aid theory

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75205
      • Southern Methodist University, Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A current DSM-IV diagnosis of panic disorder with 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:

• A history of bipolar disorder, psychosis or delusional disorders, current substance abuse or dependence

Medical Exclusion Factors:

• Patients with severe unstable medical illness, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Therapy; The training included four components: (a) educating patients about exacerbating panic symptoms through catastrophic thoughts (vicious cycle), (b) identifying negative cognitions associated with physical sensation triggers of recent panic attacks, (c) practicing replacement of maladaptive cognitions with non catastrophic explanations, and (d) instructing patients in between session exercises during Phase I.	Behavioral: Cognitive Therapy; The training included four components: (a) educating patients about exacerbating panic symptoms through catastrophic thoughts (vicious cycle), (b) identifying negative cognitions associated with physical sensation triggers of recent panic attacks, (c) practicing replacement of maladaptive cognitions with non catastrophic explanations, and (d) instructing patients in between session exercises during Phase I.; Other Names: CT
Active Comparator: Capnometry-Assisted Respiratory Training; The training included four components: (a) educating patients about the exacerbation of panic symptoms through hypocapnia; (b) directing patients' attention to potentially detrimental respiratory patterns; (c) teaching patients techniques to control their respiration, in particular end-tidal PCO2; and (d) instructing patients in between-session exercises. Between-session exercises using a portable capnometer were to be performed twice a day for 17 min at home or elsewhere during Phase I.	Behavioral: Capnometry-Assisted Respiratory Training; The training included four components: (a) educating patients about the exacerbation of panic symptoms through hypocapnia; (b) directing patients' attention to potentially detrimental respiratory patterns; (c) teaching patients techniques to control their respiration, in particular end-tidal PCO2; and (d) instructing patients in between-session exercises. Between-session exercises using a portable capnometer were to be performed twice a day for 17 min at home or elsewhere during Phase I.; Other Names: CART
Other: In-vivo exposure therapy; In this two-phase intervention, patients were randomized (within each site) to first receive five individual, weekly, 1-hr sessions of respiratory skill training (CART) or cognitive skill training (CT; Phase I, Skill Acquisition Training), followed by three weekly sessions of in-vivo exposure (Phase II, Application Training) plus a fourth session at 2-month follow-up.	Behavioral: In-vivo exposure; In this two-phase intervention, patients were randomized (within each site) to first receive five individual, weekly, 1-hr sessions of respiratory skill training (CART) or cognitive skill training (CT; Phase I, Skill Acquisition Training), followed by three weekly sessions of in-vivo exposure (Phase II, Application Training) plus a fourth session at 2-month follow-up.; Other Names: EXP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in panic symptom severity assessed by the Panic Disorder Severity Scale/CGI	Clinician administered; 7 items rated on 0 - 4 scale; scores over 9 suggest the need for formal diagnostic assessment	Pre (Week 0), Mid (Week 5), Post (Week 9), Follow-Up (Week 17)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol assessments collecting 8 saliva samples per day	was administered to subset of patients for exposure and non exposure days	Phase II (Weeks 7 - 9)

Collaborators and Investigators

• Sponsor: Southern Methodist University
• Collaborators: Boston University; University of Michigan
• Investigators: Principal Investigator: Alicia E Meuret, Ph.D., Southern Methodist University

Publications and helpful links

General Publications

• Meuret AE, Seidel A, Rosenfield B, Hofmann SG, Rosenfield D. Does fear reactivity during exposure predict panic symptom reduction? J Consult Clin Psychol. 2012 Oct;80(5):773-85. doi: 10.1037/a0028032. Epub 2012 Apr 9.
• Meuret AE, Rosenfield D, Seidel A, Bhaskara L, Hofmann SG. Respiratory and cognitive mediators of treatment change in panic disorder: evidence for intervention specificity. J Consult Clin Psychol. 2010 Oct;78(5):691-704. doi: 10.1037/a0019552.
• Meuret AE, Hofmann SG, Rosenfield D. Catastrophic Appraisal and Perceived Control as Moderators of Treatment Response in Panic Disorder. Int J Cogn Ther. 2010 Sep 1;3:262-277. doi: 10.1521/ijct.2010.3.3.262.
• Meuret AE, Trueba AF, Abelson JL, Liberzon I, Auchus R, Bhaskara L, Ritz T, Rosenfield D. High cortisol awakening response and cortisol levels moderate exposure-based psychotherapy success. Psychoneuroendocrinology. 2015 Jan;51:331-40. doi: 10.1016/j.psyneuen.2014.10.008. Epub 2014 Oct 16.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Treatment; Mediators; Moderators; Panic; Respiration panic; Cognitions
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; Agoraphobia
• Other Study ID Numbers: MEUA-2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data is available upon request