Comparison of Psychotherapy Programs to Treat Panic Disorder

Anxiety Disorders Clinical Trial

Official title:

Dynamic Treatment vs. CBT for Panic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353470
• Other study ID #: R01MH070918
• Secondary ID: R01MH070664
• Status: Completed
• Phase: Phase 3
• Start date: September 2006
• Est. completion date: September 2012

Study information

• Verified date: November 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Disease
• Panic Disorder

Intervention

Behavioral:
• Cognitive behavioral therapy
CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
• Applied relaxation training (ART)
ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
• Panic focused psychodynamic psychotherapy (PFPP)
PFPP will include 19 to 24 sessions over 12 weeks.

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Erratum In: Am J Psychiatry. 2007 Jul;164(7):1123. Am J Psychiatry. 2007 Mar;164(3):529. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Panic Disorder Severity Scale	A composite score of panic severity. High value = 28, lowest value =0. Higher=worse	12 weeks
Secondary	Sheehan Disability Scale	Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction	12 weeks
Secondary	Clinical Global Impressions Scale	Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse	12 weeks
Secondary	Hamilton Depression Rating Scale	Level of state depression. scale 0-81, 0 symptom free, 81 worst severity	12 weeks
Secondary	Hamilton Anxiety Rating Scale	level of state anxiety. 0=symptom free, 56 most severe	12 weeks
Secondary	Anxiety Disorder Sensitivity Index	Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety	12 weeks
Secondary	Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)	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
Secondary	Panic-Specific Reflective Function	Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better	12 weeks