Comparison of Psychotherapy Programs to Treat Panic Disorder
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|ClinicalTrials.gov Identifier: NCT00353470|
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : December 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders Panic Disorder Agoraphobia||Behavioral: Cognitive behavioral therapy Behavioral: Applied relaxation training (ART) Behavioral: Panic focused psychodynamic psychotherapy (PFPP)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Dynamic Treatment vs. CBT for Panic Disorder|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||September 2012|
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.
Active Comparator: 2
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.
Other Name: Panic control treatment
Active Comparator: 3
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.
Other Name: ART
- Panic Disorder Severity Scale [ Time Frame: Measured at Month 12 post-treatment ]
- Sheehan Disability Scale [ Time Frame: Measured at Month 12 post-treatment ]
- Clinical Global Impressions Scale [ Time Frame: Measured at Month 12 post-treatment ]
- Hamilton Depression Rating Scale [ Time Frame: Measured at Month 12 post-treatment ]
- Hamilton Anxiety Rating Scale [ Time Frame: Measured at Month 12 post-treatment ]
- Anxiety Disorder Sensitivity Index [ Time Frame: Measured at Month 12 post-treatment ]
- Brief Body Sensitivity Interpretation Questionnaire [ Time Frame: Measured at Month 12 post-treatment ]
- Panic-Specific Reflective Function [ Time Frame: Measured at Month 12 post-treatment ]
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): NCT00353470
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|University of Pennsylvania School of Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Barbara Milrod, MD||Weill Medical College of Cornell University|
|Principal Investigator:||Jacques P. Barber, PhD||University of Pennsylvania|