Comparison of Psychotherapy Programs to Treat Panic Disorder - Full Text View

Purpose

This study will determine the relative effectiveness of three psychotherapies in treating people with a panic disorder.

Condition	Intervention	Phase
Anxiety Disorders Panic Disorder Agoraphobia	Behavioral: Cognitive behavioral therapy Behavioral: Applied relaxation training (ART) Behavioral: Panic focused psychodynamic psychotherapy (PFPP)	Phase III

MedlinePlus related topics:

Anxiety Panic Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Dynamic Treatment vs. CBT for Panic Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Panic Disorder Severity Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sheehan Disability Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
Clinical Global Impressions Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
Hamilton Depression Rating Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: Yes ]
Hamilton Anxiety Rating Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
Anxiety Disorder Sensitivity Index [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
Brief Body Sensitivity Interpretation Questionnaire [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
Panic-Specific Reflective Function [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	233
Study Start Date:	September 2006
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive panic focused psychodynamic psychotherapy for 12 weeks	Behavioral: Panic focused psychodynamic psychotherapy (PFPP) PFPP will include 19 to 24 sessions over 12 weeks.
2: Active Comparator Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks	Behavioral: Cognitive behavioral therapy CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
3: Active Comparator Participants will receive applied relaxation training for 12 weeks	Behavioral: Applied relaxation training (ART) ART with exposure protocol will include 19 to 24 sessions over 12 weeks.

Detailed Description:

Panic disorder (PD) is a debilitating anxiety disorder. It is characterized by unexpected and repeated episodes of intense fear, accompanied by serious physical symptoms, such as chest pain, heart palpitations, shortness of breath, dizziness, or abdominal stress. Available treatments for PD include medication therapy and cognitive behavioral therapy (CBT), a type of psychotherapy that teaches people how to view panic attacks differently and how to reduce anxiety. Approximately 30% of patients refuse medication, however, and nearly 50% do not achieve remission with CBT alone. Therefore, there is a pressing need for additional non-pharmacologic treatment methods. Panic-focused psychodynamic psychotherapy (PFPP) and applied relaxation training (ART) are among some of the other available treatments for PD. During ART, individuals are taught to relax their muscles while being exposed to increasingly frightening situations. PFPP combines elements of CBT with other, more extensive approaches aimed at determining the anxiety's origin and at finding ways to reduce it. This study will compare the effectiveness of PFPP, CBT, and ART in treating PD.

Participants in this single blind study will be randomly assigned to receive PFPP, CBT, or ART for 12 weeks. All participants will attend between 19 and 24 treatment sessions over the course of the study. Upon completing the study, participants will attend monthly follow-up visits for an additional 12 months. Participants assigned to ART who have not responded by the end of treatment may opt to receive PFPP or CBT. Outcomes will be assessed using a variety of scales to determine depression and anxiety symptoms.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia
History of at least one spontaneous panic attack per week within the month prior to study entry

Exclusion Criteria:

Active substance dependence within 6 months prior to study entry
Lifetime history of any psychotic disorder, including bipolar disorder
Acutely suicidal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353470

Contacts


Contact: Barbara Milrod, MD	212-746-5868	bmilrod@med.cornell.edu

Contact: Jacques P. Barber, PhD	215-662-2306	barberj@mail.med.upenn.edu

Locations


United States, New York
	Weill Medical College of Cornell University	Recruiting
	New York, New York, United States, 10021
	Contact: Libby Graf, M.Phil. 212-746-5725 libbygraf@gmail.com
	Principal Investigator: Barbara Milrod, MD
	Sub-Investigator: Andrew C. Leon, PhD
	Sub-Investigator: Baruch Fishman, PhD

United States, Pennsylvania
	University of Pennsylvania School of Medicine	Recruiting
	Philadelphia, Pennsylvania, United States, 19104
	Principal Investigator: Jacques P. Barber, PhD
	Sub-Investigator: Diane Chambless, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Barbara Milrod, MD	Weill Medical College of Cornell University

Principal Investigator:	Jacques P. Barber, PhD	University of Pennsylvania

More Information

Responsible Party:	Weill Medical College of Cornell University ( Barbara Milrod, MD, Professor of Psychiatry )
Study ID Numbers:	R01 MH70918, R01 MH70664, DSIR 83-ATAS
First Received:	July 14, 2006
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00353470
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

PD

CBT

PFPP

Study placed in the following topic categories:

Panic Disorder

Anxiety Disorders

Mental Disorders

Agoraphobia

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on August 08, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00353470