Mechanisms of Treatment Change in Panic Disorder and Agoraphobia

NCT03547180 | Completed

• 1 other identifier: MEUA-2005
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder With Agoraphobia

Keywords

Respiration panic; Cognitions; Panic; Treatment; Mediators; Moderators

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cortisol assessments collecting 8 saliva samples per day

  Phase II (Weeks 7 - 9)

Study Arms (3)

Cognitive Therapy

ACTIVE COMPARATOR

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

Capnometry-Assisted Respiratory Training

ACTIVE COMPARATOR

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

In-vivo exposure therapy

OTHER

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

Interventions

Cognitive Therapy BEHAVIORAL

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.

Also known as: CT

Cognitive Therapy

Capnometry-Assisted Respiratory Training BEHAVIORAL

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.

Also known as: CART

Capnometry-Assisted Respiratory Training

In-vivo exposure BEHAVIORAL

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.

Also known as: EXP

In-vivo exposure therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Southern Methodist University: lead
• Boston University: collaborator
• University of Michigan: collaborator

Study Sites (1)

Southern Methodist University, Department of Psychology

Dallas, Texas, 75205, United States

Location

Related Publications (4)

• 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.

  PMID: 22486408 RESULT

• 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.

  PMID: 20873904 RESULT

• 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.

  PMID: 21088704 RESULT

• 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.

  PMID: 25462905 RESULT

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alicia E Meuret, Ph.D.

  Southern Methodist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Compliance

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: June 6, 2018
• Study Start: January 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)