NCT00128388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

4.9 years

First QC Date

August 5, 2005

Last Update Submit

June 26, 2013

Conditions

Keywords

panic disorder,psychodynamic psychotherapy,efficacy trial

Outcome Measures

Primary Outcomes (1)

  • PDSS (panic disorder severity scale)

    termination, 2, 4, 6, 12 month f/u

Secondary Outcomes (3)

  • SDS (Sheehan disability scale)

    termination, 2, 4, 6, 12 month f/u

  • HARS (Hamilton anxiety rating scale)

    termination, 2, 4, 6, 12 month f/u

  • HDRS (Hamilton depression rating scale)

    termination, 2, 4, 6, 12 month f/u

Study Arms (2)

1 PFPP

EXPERIMENTAL

Panic Focused Psychodynamic Psychotherapy

Other: PFPP

2 ART

ACTIVE COMPARATOR

Applied Relaxation Training

Other: ART

Interventions

PFPPOTHER

Psychoanalytic Psychotherapy for panic disorder

Also known as: Psychodynamic psychotherapy
1 PFPP
ARTOTHER

Applied Relaxation Training

Also known as: Applied Relaxation Training, Behavioral Therapy
2 ART

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Primary DSM-IV panic disorder with or without agoraphobia
  • Severity 5/8 minimum on the Anxiety Disorders Interview Schedule

You may not qualify if:

  • Psychosis
  • Unstable medication dosage
  • Unwilling to discontinue ongoing psychotherapy
  • Organic mental syndrome
  • Substance use or abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College

New York, New York, 10021, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Panic Disorder

Interventions

Psychotherapy, PsychodynamicBehavior Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Barbara Milrod, M.D.

    Weill Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 9, 2005

Study Start

February 1, 2000

Primary Completion

January 1, 2005

Study Completion

July 1, 2005

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations