Comparison of Psychotherapy Programs to Treat Panic Disorder
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Dynamic Treatment vs. CBT for Panic Disorder |
- Panic Disorder Severity Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 201 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
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 |
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| 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 |
More Information
Publications:
| Responsible Party: | Barbara Milrod, Professor of Psychiatry, Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00353470 History of Changes |
| Other Study ID Numbers: | R01 MH070918, R01 MH70664, DSIR 83-ATAS |
| Study First Received: | July 14, 2006 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Weill Medical College of Cornell University:
|
PD CBT PFPP |
Additional relevant MeSH terms:
|
Agoraphobia Anxiety Disorders Panic Disorder Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013