Comparison of Psychotherapy Programs to Treat Panic Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Milrod, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00353470
First received: July 14, 2006
Last updated: December 18, 2012
Last verified: December 2012

July 14, 2006
December 18, 2012
September 2006
March 2012   (final data collection date for primary outcome measure)
Panic Disorder Severity Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
Panic Disorder Severity Scale (measured 12 months following the end of treatment)
Complete list of historical versions of study NCT00353470 on ClinicalTrials.gov Archive Site
  • Sheehan Disability Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: Yes ]
  • Hamilton Anxiety Rating Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
  • Anxiety Disorder Sensitivity Index [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
  • Brief Body Sensitivity Interpretation Questionnaire [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
  • Panic-Specific Reflective Function [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale
  • Adolescent Drug Involvement Scale-Superlite
  • Clinical Global Impressions Scale
  • Hamilton Depression Rating Scale
  • Hamilton Anxiety Rating Scale
  • Anxiety Disorder Sensitivity Index
  • Brief Body Sensitivity Interpretation Questionnaire
  • Panic-Specific Reflective (all measured 12 months following the end of treatment)
Not Provided
Not Provided
 
Comparison of Psychotherapy Programs to Treat Panic Disorder
Dynamic Treatment vs. CBT for Panic Disorder

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety Disorders
  • Panic Disorder
  • Agoraphobia
  • Behavioral: Cognitive behavioral therapy
    CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
    Other Name: Panic control treatment
  • Behavioral: Applied relaxation training (ART)
    ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
    Other Name: ART
  • Behavioral: Panic focused psychodynamic psychotherapy (PFPP)
    PFPP will include 19 to 24 sessions over 12 weeks.
  • Experimental: 1
    Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
    Intervention: Behavioral: Panic focused psychodynamic psychotherapy (PFPP)
  • Active Comparator: 2
    Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
    Intervention: Behavioral: Cognitive behavioral therapy
  • Active Comparator: 3
    Participants will receive applied relaxation training for 12 weeks
    Intervention: Behavioral: Applied relaxation training (ART)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
September 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00353470
R01 MH070918, R01 MH70664, DSIR 83-ATAS
Yes
Barbara Milrod, Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: Barbara Milrod, MD Weill Medical College of Cornell University
Principal Investigator: Jacques P. Barber, PhD University of Pennsylvania
Weill Medical College of Cornell University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP