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Mechanisms of Treatment Change in Panic Disorder and Agoraphobia

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ClinicalTrials.gov Identifier: NCT03547180
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Boston University
University of Michigan
Information provided by (Responsible Party):
Alicia Meuret, Southern Methodist University

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.

Condition or disease Intervention/treatment Phase
Panic Disorder With Agoraphobia Behavioral: Cognitive Therapy Behavioral: Capnometry-Assisted Respiratory Training Behavioral: In-vivo exposure Not Applicable

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 (Clark, 1986). 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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Moderators and Mediators of Treatment Change in Panic Disorder and Agoraphobia
Study Start Date : January 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder

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 Name: 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 Name: CART

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 Name: EXP




Primary Outcome Measures :
  1. Change in panic symptom severity assessed by the Panic Disorder Severity Scale/CGI [ Time Frame: Pre (Week 0), Mid (Week 5), Post (Week 9), FU (Week 17) ]
    Clinician administered


Secondary Outcome Measures :
  1. Cortisol Assessments collecting 8 saliva samples per day [ Time Frame: Phase II (Weeks 7-9) ]
    was administered to subset of patients for exposure and non exposure days

  2. Heart rate measures using lifeshirt [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    sensor data collected using ECG/heart rate variability and pulse oximetry ppg

  3. CO2 level measures using capnometer [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    CO2 levels measured in mg HH

  4. respiratory rate measures using lifeshirt [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    sensor data collected using dual band respiration

  5. Anxiety Sensitivity Index measuring fear of panic symptoms [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    experiential measure

  6. Beck Depression Inventory measuring mood symptoms [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    experiential measure

  7. Body Sensations Questionnaire measuring fear of panic symptoms [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    experiential measure

  8. The Mobility Inventory for Agoraphobia questionnaire to assess agoraphobic avoidance [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    self-report questionnaire

  9. Agoraphobia Cognition Questionnaire to assess cognitive misappraisal [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    self-report questionnaire

  10. Anxiety Control Questionnaire to assess perceived control [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    self-report questionnaire

  11. self-report (questionnaires) [ Time Frame: Phase I and Phase II (Weeks 1 - 9) ]
    agoraphobic avoidance, cognitive misappraisal, perceived control



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547180


Locations
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United States, Texas
Southern Methodist University, Department of Psychology
Dallas, Texas, United States, 75205
Sponsors and Collaborators
Southern Methodist University
Boston University
University of Michigan
Investigators
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Principal Investigator: Alicia E Meuret, Ph.D. Southern Methodist University

Publications of Results:
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Responsible Party: Alicia Meuret, Associate Professor of Psychology, Southern Methodist University
ClinicalTrials.gov Identifier: NCT03547180     History of Changes
Other Study ID Numbers: MEUA-2005
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is available upon request

Keywords provided by Alicia Meuret, Southern Methodist University:
Respiration panic
Cognitions
Panic
Treatment
Mediators
Moderators

Additional relevant MeSH terms:
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Disease
Panic Disorder
Agoraphobia
Pathologic Processes
Anxiety Disorders
Mental Disorders