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Psychodynamic Therapy for Treating Panic Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00128388
First received: August 5, 2005
Last updated: February 13, 2008
Last verified: February 2008
History of Changes
  Purpose

This study will determine the effectiveness of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training in treating adults with panic disorder.


Condition Intervention Phase
Panic Disorder
 Other: PFPP
Other: ART
 Phase 2
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: Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • PDSS (panic disorder severity scale) [ Time Frame: termination, 2, 4, 6, 12 month f/u ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SDS (Sheehan disability scale) [ Time Frame: termination, 2, 4, 6, 12 month f/u ] [ Designated as safety issue: No ]
  • HARS (Hamilton anxiety rating scale) [ Time Frame: termination, 2, 4, 6, 12 month f/u ] [ Designated as safety issue: No ]
  • HDRS (Hamilton depression rating scale) [ Time Frame: termination, 2, 4, 6, 12 month f/u ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: February 2000
Study Completion Date: July 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 PFPP
Panic Focused Psychodynamic Psychotherapy
 Other: PFPP
Psychoanalytic Psychotherapy for panic disorder
Other Names:
  • PFPP
  • Psychodynamic psychotherapy
Active Comparator: 2 ART
Applied Relaxation Training
 Other: ART
Applied Relaxation Training
Other Names:
  • ART
  • Applied Relaxation Training
  • Behavioral Therapy

Detailed Description:

This is a randomized controlled trial of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training, a less active form of treatment in other studies, for adults with primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) panic disorder.

Forty nine patients who have signed written consent who have primary DSM-IV panic disorder have been entered into the study. Randomization has been stratified by presence of major depression and use of psychoactive, anti-panic medications. Medications, if present, have been held constant. All patients have received 24 sessions of either psychodynamic psychotherapy, or applied relaxation training for panic disorder. This study is currently closed for recruitment, although final follow-up assessments have yet to be completed.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-55 years old
  • Primary DSM-IV panic disorder with or without agoraphobia
  • Severity 5/8 minimum on the Anxiety Disorders Interview Schedule

Exclusion Criteria:

  • Psychosis
  • Unstable medication dosage
  • Unwilling to discontinue ongoing psychotherapy
  • Organic mental syndrome
  • Substance use or abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128388

Locations
United States, New York
Weill Medical College
New York City, New York, United States, 10021
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Barbara Milrod, M.D. Weill Medical College
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Barbara Milrod, M.D., Professor of Psychiatry, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00128388     History of Changes
Other Study ID Numbers: K23 MH01849, DSIR AT-CD
Study First Received: August 5, 2005
Last Updated: February 13, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
panic disorder,
psychodynamic psychotherapy,
efficacy trial

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 13, 2013