Comparison of Psychotherapy Programs to Treat Panic Disorder
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 14, 2006 | ||||||||
| Last Updated Date | December 18, 2012 | ||||||||
| Start Date ICMJE | September 2006 | ||||||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Panic Disorder Severity Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Panic Disorder Severity Scale (measured 12 months following the end of treatment) | ||||||||
| Change History | Complete list of historical versions of study NCT00353470 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of Psychotherapy Programs to Treat Panic Disorder | ||||||||
| Official Title ICMJE | Dynamic Treatment vs. CBT for Panic Disorder | ||||||||
| Brief Summary | This study will determine the relative effectiveness of three psychotherapies in treating people with a panic disorder. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 201 | ||||||||
| Completion Date | September 2012 | ||||||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00353470 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH070918, R01 MH70664, DSIR 83-ATAS | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Barbara Milrod, Weill Medical College of Cornell University | ||||||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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