Comparison of Psychotherapy Programs to Treat Panic Disorder

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00353470

Collaborator

National Institute of Mental Health (NIMH) (NIH)

201

Enrollment

Locations

Arms

Duration (Months)

100.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2006

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Panic Disorder Severity Scale [Measured at Month 12 post-treatment]

Secondary Outcome Measures

Sheehan Disability Scale [Measured at Month 12 post-treatment]
Clinical Global Impressions Scale [Measured at Month 12 post-treatment]
Hamilton Depression Rating Scale [Measured at Month 12 post-treatment]
Hamilton Anxiety Rating Scale [Measured at Month 12 post-treatment]
Anxiety Disorder Sensitivity Index [Measured at Month 12 post-treatment]
Brief Body Sensitivity Interpretation Questionnaire [Measured at Month 12 post-treatment]
Panic-Specific Reflective Function [Measured at Month 12 post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Medical College of Cornell University	New York	New York	United States	10065
2	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

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