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Psychodynamic Therapy for Treating Panic Disorder

Primary Purpose

Panic Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PFPP
ART
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring panic disorder,, psychodynamic psychotherapy,, efficacy trial

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 PFPP

2 ART

Arm Description

Panic Focused Psychodynamic Psychotherapy

Applied Relaxation Training

Outcomes

Primary Outcome Measures

PDSS (panic disorder severity scale)

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2005
Last Updated
June 26, 2013
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00128388
Brief Title
Psychodynamic Therapy for Treating Panic Disorder
Official Title
Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
panic disorder,, psychodynamic psychotherapy,, efficacy trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 PFPP
Arm Type
Experimental
Arm Description
Panic Focused Psychodynamic Psychotherapy
Arm Title
2 ART
Arm Type
Active Comparator
Arm Description
Applied Relaxation Training
Intervention Type
Other
Intervention Name(s)
PFPP
Other Intervention Name(s)
Psychodynamic psychotherapy
Intervention Description
Psychoanalytic Psychotherapy for panic disorder
Intervention Type
Other
Intervention Name(s)
ART
Other Intervention Name(s)
Applied Relaxation Training, Behavioral Therapy
Intervention Description
Applied Relaxation Training
Primary Outcome Measure Information:
Title
PDSS (panic disorder severity scale)
Time Frame
termination, 2, 4, 6, 12 month f/u
Secondary Outcome Measure Information:
Title
SDS (Sheehan disability scale)
Time Frame
termination, 2, 4, 6, 12 month f/u
Title
HARS (Hamilton anxiety rating scale)
Time Frame
termination, 2, 4, 6, 12 month f/u
Title
HDRS (Hamilton depression rating scale)
Time Frame
termination, 2, 4, 6, 12 month f/u

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Milrod, M.D.
Organizational Affiliation
Weill Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32880104
Citation
Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
Results Reference
derived
PubMed Identifier
19026262
Citation
Klass ET, Milrod BL, Leon AC, Kay SJ, Schwalberg M, Li C, Markowitz JC. Does interpersonal loss preceding panic disorder onset moderate response to psychotherapy? An exploratory study. J Clin Psychiatry. 2009 Mar;70(3):406-11. doi: 10.4088/jcp.08m04248. Epub 2008 Nov 18.
Results Reference
derived
PubMed Identifier
17592913
Citation
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. doi: 10.4088/jcp.v68n0610.
Results Reference
derived

Learn more about this trial

Psychodynamic Therapy for Treating Panic Disorder

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