Clinical trial NCT00128388: Psychodynamic Therapy for Treating Panic Disorder
Official title: Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Panic Disorder
Keywords: panic disorder,
psychodynamic psychotherapy,
efficacy trial
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-08-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PDSS (panic disorder severity scale)
timeFrame: termination, 2, 4, 6, 12 month f/u
Secondary outcomes:
measure: SDS (Sheehan disability scale)
timeFrame: termination, 2, 4, 6, 12 month f/u
measure: HARS (Hamilton anxiety rating scale)
timeFrame: termination, 2, 4, 6, 12 month f/u
measure: HDRS (Hamilton depression rating scale)
timeFrame: termination, 2, 4, 6, 12 month f/u
Other outcomes:
Locations:
city: New York City
country: United States
facility: Weill Medical College
state: New York
Study officials:
affiliation: Weill Medical College
name: Barbara Milrod, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.