NCT00353470

Brief Summary

This study will determine the relative effectiveness of three psychotherapies in treating people with a panic disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

November 1, 2022

Enrollment Period

5.5 years

First QC Date

July 14, 2006

Results QC Date

November 2, 2022

Last Update Submit

November 30, 2022

Conditions

Anxiety DisordersPanic DisorderAgoraphobia

Keywords

PDCBTPFPP

Outcome Measures

Primary Outcomes (1)

  • Panic Disorder Severity Scale

    A composite score of panic severity. High value = 28, lowest value =0. Higher=worse

    12 weeks

Secondary Outcomes (7)

  • Sheehan Disability Scale

    12 weeks

  • Clinical Global Impressions Scale

    12 weeks

  • Hamilton Depression Rating Scale

    12 weeks

  • Hamilton Anxiety Rating Scale

    12 weeks

  • Anxiety Disorder Sensitivity Index

    12 weeks

  • +2 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Participants will receive panic focused psychodynamic psychotherapy for 12 weeks

Behavioral: Panic focused psychodynamic psychotherapy (PFPP)

2

ACTIVE COMPARATOR

Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks

Behavioral: Cognitive behavioral therapy

3

ACTIVE COMPARATOR

Participants will receive applied relaxation training for 12 weeks

Behavioral: Applied relaxation training (ART)

Interventions

Cognitive behavioral therapyBEHAVIORAL

CBT for panic disorder will include 19 to 24 sessions over 12 weeks.

Also known as: Panic control treatment
2
Applied relaxation training (ART)BEHAVIORAL

ART with exposure protocol will include 19 to 24 sessions over 12 weeks.

Also known as: ART
3
Panic focused psychodynamic psychotherapy (PFPP)BEHAVIORAL

PFPP will include 19 to 24 sessions over 12 weeks.

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia
  • History of at least one spontaneous panic attack per week within the month prior to study entry

You may not qualify if:

  • Active substance dependence within 6 months prior to study entry
  • Lifetime history of any psychotic disorder, including bipolar disorder
  • Acutely suicidal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (10)

  • Milrod B, Leon AC, Busch F, Rudden M, Schwalberg M, Clarkin J, Aronson A, Singer M, Turchin W, Klass ET, Graf E, Teres JJ, Shear MK. A randomized controlled clinical trial of psychoanalytic psychotherapy for panic disorder. Am J Psychiatry. 2007 Feb;164(2):265-72. doi: 10.1176/ajp.2007.164.2.265.

    PMID: 17267789BACKGROUND

  • 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.

    PMID: 17592913BACKGROUND

  • Milrod B, Chambless DL, Gallop R, Busch FN, Schwalberg M, McCarthy KS, Gross C, Sharpless BA, Leon AC, Barber JP. Psychotherapies for Panic Disorder: A Tale of Two Sites. J Clin Psychiatry. 2016 Jul;77(7):927-35. doi: 10.4088/JCP.14m09507.

    PMID: 27464313RESULT

  • Keefe JR, Chambless DL, Barber JP, Milrod BL. Predictors and moderators of treatment dropout in cognitive-behavioral and psychodynamic therapies for panic disorder. Psychother Res. 2021 Apr;31(4):432-442. doi: 10.1080/10503307.2020.1784487. Epub 2020 Jun 25.

    PMID: 32584211DERIVED

  • Barber JP, Milrod B, Gallop R, Solomonov N, Rudden MG, McCarthy KS, Chambless DL. Processes of therapeutic change: Results from the Cornell-Penn Study of Psychotherapies for Panic Disorder. J Couns Psychol. 2020 Mar;67(2):222-231. doi: 10.1037/cou0000417.

    PMID: 32105128DERIVED

  • Keefe JR, Huque ZM, DeRubeis RJ, Barber JP, Milrod BL, Chambless DL. In-session emotional expression predicts symptomatic and panic-specific reflective functioning improvements in panic-focused psychodynamic psychotherapy. Psychotherapy (Chic). 2019 Dec;56(4):514-525. doi: 10.1037/pst0000215. Epub 2019 Mar 14.

    PMID: 30869969DERIVED

  • Solomonov N, Falkenstrom F, Gorman BS, McCarthy KS, Milrod B, Rudden MG, Chambless DL, Barber JP. Differential effects of alliance and techniques on Panic-Specific Reflective Function and misinterpretation of bodily sensations in two treatments for panic. Psychother Res. 2020 Jan;30(1):97-111. doi: 10.1080/10503307.2019.1585591. Epub 2019 Mar 1.

    PMID: 30821630DERIVED

  • Suarez-Jimenez B, Zhu X, Lazarov A, Mann JJ, Schneier F, Gerber A, Barber JP, Chambless DL, Neria Y, Milrod B, Markowitz JC. Anterior hippocampal volume predicts affect-focused psychotherapy outcome. Psychol Med. 2020 Feb;50(3):396-402. doi: 10.1017/S0033291719000187. Epub 2019 Feb 18.

    PMID: 30773148DERIVED

  • McCarthy KS, Chambless DL, Solomonov N, Milrod B, Barber JP. Twelve-Month Outcomes Following Successful Panic-Focused Psychodynamic Psychotherapy, Cognitive-Behavioral Therapy, or Applied Relaxation Training for Panic Disorder. J Clin Psychiatry. 2018 Sep 11;79(5):17m11807. doi: 10.4088/JCP.17m11807.

    PMID: 30256548DERIVED

  • Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.

    PMID: 29336228DERIVED

MeSH Terms

Conditions

Anxiety DisordersPanic DisorderAgoraphobia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Barbara Milrod, M.D., PI
Organization
Albert Einstein College of Medicine
bmilrod@montefiore.org
212-595-0806

Study Officials

  • Barbara Milrod, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Jacques P. Barber, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 18, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

December 23, 2022

Results First Posted

December 23, 2022

Record last verified: 2022-11

Locations

US(2)