Comparison of Psychotherapy Programs to Treat Panic Disorder

NCT ID: NCT00353470

Last Updated: 2022-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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Panic disorder (PD) is a debilitating anxiety disorder. It is characterized by unexpected and repeated episodes of intense fear, accompanied by serious physical symptoms, such as chest pain, heart palpitations, shortness of breath, dizziness, or abdominal stress. Available treatments for PD include medication therapy and cognitive behavioral therapy (CBT), a type of psychotherapy that teaches people how to view panic attacks differently and how to reduce anxiety. Approximately 30% of patients refuse medication, however, and nearly 50% do not achieve remission with CBT alone. Therefore, there is a pressing need for additional non-pharmacologic treatment methods. Panic-focused psychodynamic psychotherapy (PFPP) and applied relaxation training (ART) are among some of the other available treatments for PD. During ART, individuals are taught to relax their muscles while being exposed to increasingly frightening situations. PFPP combines elements of CBT with other, more extensive approaches aimed at determining the anxiety's origin and at finding ways to reduce it. This study will compare the effectiveness of PFPP, CBT, and ART in treating PD.

Participants in this single blind study will be randomly assigned to receive PFPP, CBT, or ART for 12 weeks. All participants will attend between 19 and 24 treatment sessions over the course of the study. Upon completing the study, participants will attend monthly follow-up visits for an additional 12 months. Participants assigned to ART who have not responded by the end of treatment may opt to receive PFPP or CBT. Outcomes will be assessed using a variety of scales to determine depression and anxiety symptoms.

Conditions

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Anxiety Disorders Panic Disorder Agoraphobia

Keywords

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PD CBT PFPP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive panic focused psychodynamic psychotherapy for 12 weeks

Group Type EXPERIMENTAL

Panic focused psychodynamic psychotherapy (PFPP)

Intervention Type BEHAVIORAL

PFPP will include 19 to 24 sessions over 12 weeks.

2

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

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

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

3

Participants will receive applied relaxation training for 12 weeks

Group Type ACTIVE_COMPARATOR

Applied relaxation training (ART)

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive behavioral therapy

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

Intervention Type BEHAVIORAL

Applied relaxation training (ART)

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

Intervention Type BEHAVIORAL

Panic focused psychodynamic psychotherapy (PFPP)

PFPP will include 19 to 24 sessions over 12 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Panic control treatment ART

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Milrod, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Jacques P. Barber, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Weill Medical College of Cornell University

New York, New York, United States

Site Status

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17267789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17592913 (View on PubMed)

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.

Reference Type RESULT
PMID: 27464313 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32584211 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32105128 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30869969 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30821630 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30773148 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30256548 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29336228 (View on PubMed)

Other Identifiers

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R01MH070664

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH070918

Identifier Type: NIH

Identifier Source: org_study_id

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