Clinical trial NCT03547180: 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
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder With Agoraphobia
Keywords: Respiration panic
Cognitions
Panic
Treatment
Mediators
Moderators
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
Collaborators: name: Boston University
name: University of Michigan
First posted: 2018-06-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in panic symptom severity assessed by the Panic Disorder Severity Scale/CGI
timeFrame: Pre (Week 0), Mid (Week 5), Post (Week 9), Follow-Up (Week 17)
Secondary outcomes:
measure: Cortisol assessments collecting 8 saliva samples per day
timeFrame: Phase II (Weeks 7 - 9)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University, Department of Psychology
state: Texas
Study officials:
affiliation: Southern Methodist University
name: Alicia E Meuret, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.