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Comparison of Psychotherapy Programs to Treat Panic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00353470
Recruitment Status : Completed
First Posted : July 18, 2006
Results First Posted : December 23, 2022
Last Update Posted : December 23, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Anxiety Disorders Panic Disorder Agoraphobia Behavioral: Cognitive behavioral therapy Behavioral: Applied relaxation training (ART) Behavioral: Panic focused psychodynamic psychotherapy (PFPP) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dynamic Treatment vs. CBT for Panic Disorder
Study Start Date : September 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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 Name: ART




Primary Outcome Measures :
  1. Panic Disorder Severity Scale [ Time Frame: 12 weeks ]
    A composite score of panic severity. High value = 28, lowest value =0. Higher=worse


Secondary Outcome Measures :
  1. Sheehan Disability Scale [ Time Frame: 12 weeks ]
    Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction

  2. Clinical Global Impressions Scale [ Time Frame: 12 weeks ]
    Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse

  3. Hamilton Depression Rating Scale [ Time Frame: 12 weeks ]
    Level of state depression. scale 0-81, 0 symptom free, 81 worst severity

  4. Hamilton Anxiety Rating Scale [ Time Frame: 12 weeks ]
    level of state anxiety. 0=symptom free, 56 most severe

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353470


Locations
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United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Barbara Milrod, MD Weill Medical College of Cornell University
Principal Investigator: Jacques P. Barber, PhD University of Pennsylvania
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00353470    
Other Study ID Numbers: R01MH070918 ( U.S. NIH Grant/Contract )
R01MH070664 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2006    Key Record Dates
Results First Posted: December 23, 2022
Last Update Posted: December 23, 2022
Last Verified: November 2022
Keywords provided by Weill Medical College of Cornell University:
PD
CBT
PFPP
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Panic Disorder
Agoraphobia
Pathologic Processes
Mental Disorders