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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00353470 |
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 |
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 |
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
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Behavioral: Panic focused psychodynamic psychotherapy (PFPP)
PFPP will include 19 to 24 sessions over 12 weeks.
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2: Active Comparator
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
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Behavioral: Cognitive behavioral therapy
CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
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3: Active Comparator
Participants will receive applied relaxation training for 12 weeks
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Behavioral: Applied relaxation training (ART)
ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara Milrod, MD | 212-746-5868 | bmilrod@med.cornell.edu |
Contact: Jacques P. Barber, PhD | 215-662-2306 | barberj@mail.med.upenn.edu |
United States, New York | |
Weill Medical College of Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Tempe Watts, B.A. 646-253-2841 tempe.watts@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 |
Principal Investigator: | Barbara Milrod, MD | Weill Medical College of Cornell University |
Principal Investigator: | Jacques P. Barber, PhD | University of Pennsylvania |
Responsible Party: | Weill Medical College of Cornell University ( Barbara Milrod, MD, Professor of Psychiatry ) |
Study ID Numbers: | R01 MH70918, R01 MH70664, DSIR 83-ATAS |
Study First Received: | July 14, 2006 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00353470 |
Health Authority: | United States: Federal Government |
PD CBT PFPP |
Panic Disorder Anxiety Disorders Mental Disorders Agoraphobia |
Pathologic Processes Disease |