Comparison of Psychotherapy Programs to Treat Panic Disorder

November 30, 2022 updated by: Weill Medical College of Cornell University

Dynamic Treatment vs. CBT for Panic Disorder

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Behavioral: Panic focused psychodynamic psychotherapy (PFPP)
PFPP will include 19 to 24 sessions over 12 weeks.
Active Comparator: 2
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Behavioral: Cognitive behavioral therapy
CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
Other Names:
  • Panic control treatment
Active Comparator: 3
Participants will receive applied relaxation training for 12 weeks
Behavioral: Applied relaxation training (ART)
ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
Other Names:
  • ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Panic Disorder Severity Scale
Time Frame: 12 weeks
A composite score of panic severity. High value = 28, lowest value =0. Higher=worse
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sheehan Disability Scale
Time Frame: 12 weeks
Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction
12 weeks
Clinical Global Impressions Scale
Time Frame: 12 weeks
Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
12 weeks
Hamilton Depression Rating Scale
Time Frame: 12 weeks
Level of state depression. scale 0-81, 0 symptom free, 81 worst severity
12 weeks
Hamilton Anxiety Rating Scale
Time Frame: 12 weeks
level of state anxiety. 0=symptom free, 56 most severe
12 weeks
Anxiety Disorder Sensitivity Index
Time Frame: 12 weeks
Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety
12 weeks
Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)
Time Frame: 12 weeks
The BBSIQ measures how physically sensitive the person is to physical symptoms of anxiety; (scores range 0-63) 0= no anxiety; 63= highest levels of physical anxiety
12 weeks
Panic-Specific Reflective Function
Time Frame: 12 weeks
Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Barbara Milrod, MD, Weill Medical College of Cornell University
  • Principal Investigator: Jacques P. Barber, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 14, 2006

First Submitted That Met QC Criteria

July 14, 2006

First Posted (Estimate)

July 18, 2006

Study Record Updates

Last Update Posted (Estimate)

December 23, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH070918 (U.S. NIH Grant/Contract)
  • R01MH070664 (U.S. NIH Grant/Contract)

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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