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Psychodynamic Therapy for Treating Panic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128388
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : June 27, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE August 5, 2005
First Posted Date  ICMJE August 9, 2005
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE February 2000
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
PDSS (panic disorder severity scale) [ Time Frame: termination, 2, 4, 6, 12 month f/u ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2005)
PDSS (panic disorder severity scale)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
  • SDS (Sheehan disability scale) [ Time Frame: termination, 2, 4, 6, 12 month f/u ]
  • HARS (Hamilton anxiety rating scale) [ Time Frame: termination, 2, 4, 6, 12 month f/u ]
  • HDRS (Hamilton depression rating scale) [ Time Frame: termination, 2, 4, 6, 12 month f/u ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2005)
  • SDS (Sheehan disability scale)
  • HARS (Hamilton anxiety rating scale)
  • HDRS (Hamilton depression rating scale)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychodynamic Therapy for Treating Panic Disorder
Official Title  ICMJE Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Panic Disorder
Intervention  ICMJE
  • Other: PFPP
    Psychoanalytic Psychotherapy for panic disorder
    Other Name: Psychodynamic psychotherapy
  • Other: ART
    Applied Relaxation Training
    Other Names:
    • Applied Relaxation Training
    • Behavioral Therapy
Study Arms  ICMJE
  • Experimental: 1 PFPP
    Panic Focused Psychodynamic Psychotherapy
    Intervention: Other: PFPP
  • Active Comparator: 2 ART
    Applied Relaxation Training
    Intervention: Other: ART
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2008)
49
Original Enrollment  ICMJE
 (submitted: August 5, 2005)
52
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00128388
Other Study ID Numbers  ICMJE K23MH001849( U.S. NIH Grant/Contract )
K23MH001849 ( U.S. NIH Grant/Contract )
DSIR AT-CD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara Milrod, M.D., Professor of Psychiatry, 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
Principal Investigator: Barbara Milrod, M.D. Weill Medical College
PRS Account Weill Medical College of Cornell University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP