Psychodynamic Therapy for Treating Panic Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00128388

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 II Phase III

MedlinePlus related topics: Anxiety Panic Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder

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
1 PFPP: Experimental Panic Focused Psychodynamic Psychotherapy	Other: PFPP Psychoanalytic Psychotherapy for panic disorder
2 ART: Active Comparator Applied Relaxation Training	Other: ART Applied Relaxation Training

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

Publications indexed to this study:

Milrod BL, Leon AC, Barber JP, Markowitz JC, Graf E. Do comorbid personality disorders moderate panic-focused psychotherapy? An exploratory examination of the American Psychiatric Association practice guideline. J Clin Psychiatry. 2007 Jun;68(6):885-91.

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

Keywords provided by National Institute of Mental Health (NIMH):

panic disorder,
psychodynamic psychotherapy,
efficacy trial

Study placed in the following topic categories:

Panic Disorder
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009