Comparison of Psychotherapy Programs to Treat Panic Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Milrod, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00353470
First received: July 14, 2006
Last updated: December 18, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Panic Disorder Severity Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353470

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
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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 April 17, 2014