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Mechanisms of Treatment Change in Panic Disorder and Agoraphobia

Primary Purpose

Panic Disorder With Agoraphobia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Therapy
Capnometry-Assisted Respiratory Training
In-vivo exposure
Sponsored by
Southern Methodist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder With Agoraphobia focused on measuring Respiration panic, Cognitions, Panic, Treatment, Mediators, Moderators

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Methodist University, Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Cognitive Therapy

Capnometry-Assisted Respiratory Training

In-vivo exposure therapy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cortisol assessments collecting 8 saliva samples per day
was administered to subset of patients for exposure and non exposure days

Full Information

First Posted
February 1, 2016
Last Updated
April 29, 2020
Sponsor
Southern Methodist University
Collaborators
Boston University, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03547180
Brief Title
Mechanisms of Treatment Change in Panic Disorder and Agoraphobia
Official Title
Moderators and Mediators of Treatment Change in Panic Disorder and Agoraphobia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Methodist University
Collaborators
Boston University, University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder With Agoraphobia
Keywords
Respiration panic, Cognitions, Panic, Treatment, Mediators, Moderators

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Capnometry-Assisted Respiratory Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
In-vivo exposure therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Other Intervention Name(s)
CT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Capnometry-Assisted Respiratory Training
Other Intervention Name(s)
CART
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
In-vivo exposure
Other Intervention Name(s)
EXP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in panic symptom severity assessed by the Panic Disorder Severity Scale/CGI
Description
Clinician administered; 7 items rated on 0 - 4 scale; scores over 9 suggest the need for formal diagnostic assessment
Time Frame
Pre (Week 0), Mid (Week 5), Post (Week 9), Follow-Up (Week 17)
Secondary Outcome Measure Information:
Title
Cortisol assessments collecting 8 saliva samples per day
Description
was administered to subset of patients for exposure and non exposure days
Time Frame
Phase II (Weeks 7 - 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia E Meuret, Ph.D.
Organizational Affiliation
Southern Methodist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Methodist University, Department of Psychology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is available upon request
Citations:
PubMed Identifier
22486408
Citation
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.
Results Reference
result
PubMed Identifier
20873904
Citation
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.
Results Reference
result
PubMed Identifier
21088704
Citation
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.
Results Reference
result
PubMed Identifier
25462905
Citation
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.
Results Reference
result

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Mechanisms of Treatment Change in Panic Disorder and Agoraphobia

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