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Clinical Trials/NCT00353470
NCT00353470
Completed
Phase 3

Dynamic Treatment vs. CBT for Panic Disorder

Weill Medical College of Cornell University2 sites in 1 country201 target enrollmentSeptember 2006

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Weill Medical College of Cornell University
Enrollment
201
Locations
2
Primary Endpoint
Panic Disorder Severity Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
September 2012
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Panic Disorder Severity Scale

Time Frame: 12 weeks

A composite score of panic severity. High value = 28, lowest value =0. Higher=worse

Secondary Outcomes

  • Sheehan Disability Scale(12 weeks)
  • Anxiety Disorder Sensitivity Index(12 weeks)
  • Panic-Specific Reflective Function(12 weeks)
  • Hamilton Depression Rating Scale(12 weeks)
  • Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)(12 weeks)
  • Clinical Global Impressions Scale(12 weeks)
  • Hamilton Anxiety Rating Scale(12 weeks)

Study Sites (2)

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