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

Tracking Information

First Received Date ^ICMJE

August 5, 2005

Last Updated Date

February 13, 2008

Start Date ^ICMJE

February 2000

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

PDSS (panic disorder severity scale)

Change History

Complete list of historical versions of study NCT00128388 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

SDS (Sheehan disability scale)
HARS (Hamilton anxiety rating scale)
HDRS (Hamilton depression rating scale)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Panic Disorder

Intervention ^ICMJE

Other: PFPP
Psychoanalytic Psychotherapy for panic disorder
Other Names:
- PFPP
- Psychodynamic psychotherapy
Other: ART
Applied Relaxation Training
Other Names:
- ART
- Applied Relaxation Training
- Behavioral Therapy

Study Arm (s)

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

Enrollment ^ICMJE

Completion Date

July 2005

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00128388

Other Study ID Numbers ^ICMJE

K23 MH01849, DSIR AT-CD

Has Data Monitoring Committee

Responsible Party

Barbara Milrod, M.D., Professor of Psychiatry, Weill Medical College of Cornell University

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Barbara Milrod, M.D.

Weill Medical College

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

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

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