Expired Study
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New York City, New York 10021


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.


Study summary:

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.


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


Study is Available At:


Original ID:

K23 MH01849


NCT ID:

NCT00128388


Secondary ID:

K23MH001849


Study Acronym:


Brief Title:

Psychodynamic Therapy for Treating Panic Disorder


Official Title:

Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Weill Medical College of Cornell University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

49


Enrollment Type:

Actual


Overall Contact Information

Official Name:Barbara Milrod, M.D.
Principal Investigator
Weill Medical College

Study Dates

Start Date:February 2000
Completion Date:July 2005
Completion Type:Actual
Primary Completion Date:January 2005
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 26, 2013
First Received Date:August 5, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:HDRS (Hamilton depression rating scale)
Time Frame:termination, 2, 4, 6, 12 month f/u
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:HARS (Hamilton anxiety rating scale)
Time Frame:termination, 2, 4, 6, 12 month f/u
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:SDS (Sheehan disability scale)
Time Frame:termination, 2, 4, 6, 12 month f/u
Safety Issues:False
Outcome Type:Primary Outcome
Measure:PDSS (panic disorder severity scale)
Time Frame:termination, 2, 4, 6, 12 month f/u
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:PFPP
Description:Psychoanalytic Psychotherapy for panic disorder
Arm Name:1 PFPP
Other Name:PFPP
Intervention Type:Other
Name:ART
Description:Applied Relaxation Training
Arm Name:2 ART
Other Name:ART

Study Arms

Study Arm Type:Experimental
Arm Name:1 PFPP
Description:Panic Focused Psychodynamic Psychotherapy
Study Arm Type:Active Comparator
Arm Name:2 ART
Description:Applied Relaxation Training

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Weill Medical College of Cornell University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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