- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00128388
Psychodynamic Therapy for Treating Panic Disorder
Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder
Study Overview
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
New York City, New York, United States, 10021
- Weill Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 PFPP
Panic Focused Psychodynamic Psychotherapy
|
Psychoanalytic Psychotherapy for panic disorder
Other Names:
|
Active Comparator: 2 ART
Applied Relaxation Training
|
Applied Relaxation Training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PDSS (panic disorder severity scale)
Time Frame: termination, 2, 4, 6, 12 month f/u
|
termination, 2, 4, 6, 12 month f/u
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SDS (Sheehan disability scale)
Time Frame: termination, 2, 4, 6, 12 month f/u
|
termination, 2, 4, 6, 12 month f/u
|
HARS (Hamilton anxiety rating scale)
Time Frame: termination, 2, 4, 6, 12 month f/u
|
termination, 2, 4, 6, 12 month f/u
|
HDRS (Hamilton depression rating scale)
Time Frame: termination, 2, 4, 6, 12 month f/u
|
termination, 2, 4, 6, 12 month f/u
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Barbara Milrod, M.D., Weill Medical College
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23MH001849 (U.S. NIH Grant/Contract)
- DSIR AT-CD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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