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Comparison of Psychotherapy Programs to Treat Panic Disorder

Primary Purpose

Anxiety Disorders, Panic Disorder, Agoraphobia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Applied relaxation training (ART)
Panic focused psychodynamic psychotherapy (PFPP)
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring PD, CBT, PFPP

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Weill Medical College of Cornell University
  • University of Pennsylvania School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Participants will receive panic focused psychodynamic psychotherapy for 12 weeks

Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks

Participants will receive applied relaxation training for 12 weeks

Outcomes

Primary Outcome Measures

Panic Disorder Severity Scale
A composite score of panic severity. High value = 28, lowest value =0. Higher=worse

Secondary Outcome Measures

Sheehan Disability Scale
Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction
Clinical Global Impressions Scale
Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
Hamilton Depression Rating Scale
Level of state depression. scale 0-81, 0 symptom free, 81 worst severity
Hamilton Anxiety Rating Scale
level of state anxiety. 0=symptom free, 56 most severe
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
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
Panic-Specific Reflective Function
Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better

Full Information

First Posted
July 14, 2006
Last Updated
November 30, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00353470
Brief Title
Comparison of Psychotherapy Programs to Treat Panic Disorder
Official Title
Dynamic Treatment vs. CBT for Panic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Panic Disorder, Agoraphobia
Keywords
PD, CBT, PFPP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Arm Title
3
Arm Type
Active Comparator
Arm Description
Participants will receive applied relaxation training for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Other Intervention Name(s)
Panic control treatment
Intervention Description
CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Applied relaxation training (ART)
Other Intervention Name(s)
ART
Intervention Description
ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Panic focused psychodynamic psychotherapy (PFPP)
Intervention Description
PFPP will include 19 to 24 sessions over 12 weeks.
Primary Outcome Measure Information:
Title
Panic Disorder Severity Scale
Description
A composite score of panic severity. High value = 28, lowest value =0. Higher=worse
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale
Description
Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction
Time Frame
12 weeks
Title
Clinical Global Impressions Scale
Description
Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
Time Frame
12 weeks
Title
Hamilton Depression Rating Scale
Description
Level of state depression. scale 0-81, 0 symptom free, 81 worst severity
Time Frame
12 weeks
Title
Hamilton Anxiety Rating Scale
Description
level of state anxiety. 0=symptom free, 56 most severe
Time Frame
12 weeks
Title
Anxiety Disorder Sensitivity Index
Description
Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety
Time Frame
12 weeks
Title
Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)
Description
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
Time Frame
12 weeks
Title
Panic-Specific Reflective Function
Description
Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Milrod, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques P. Barber, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17267789
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.
Results Reference
background
PubMed Identifier
17592913
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.
Results Reference
background
PubMed Identifier
27464313
Citation
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.
Results Reference
result
PubMed Identifier
32584211
Citation
Keefe JR, Chambless DL, Barber JP, Milrod BL. Predictors and moderators of treatment dropout in cognitive-behavioral and psychodynamic therapies for panic disorder. Psychother Res. 2021 Apr;31(4):432-442. doi: 10.1080/10503307.2020.1784487. Epub 2020 Jun 25.
Results Reference
derived
PubMed Identifier
32105128
Citation
Barber JP, Milrod B, Gallop R, Solomonov N, Rudden MG, McCarthy KS, Chambless DL. Processes of therapeutic change: Results from the Cornell-Penn Study of Psychotherapies for Panic Disorder. J Couns Psychol. 2020 Mar;67(2):222-231. doi: 10.1037/cou0000417.
Results Reference
derived
PubMed Identifier
30869969
Citation
Keefe JR, Huque ZM, DeRubeis RJ, Barber JP, Milrod BL, Chambless DL. In-session emotional expression predicts symptomatic and panic-specific reflective functioning improvements in panic-focused psychodynamic psychotherapy. Psychotherapy (Chic). 2019 Dec;56(4):514-525. doi: 10.1037/pst0000215. Epub 2019 Mar 14.
Results Reference
derived
PubMed Identifier
30821630
Citation
Solomonov N, Falkenstrom F, Gorman BS, McCarthy KS, Milrod B, Rudden MG, Chambless DL, Barber JP. Differential effects of alliance and techniques on Panic-Specific Reflective Function and misinterpretation of bodily sensations in two treatments for panic. Psychother Res. 2020 Jan;30(1):97-111. doi: 10.1080/10503307.2019.1585591. Epub 2019 Mar 1.
Results Reference
derived
PubMed Identifier
30773148
Citation
Suarez-Jimenez B, Zhu X, Lazarov A, Mann JJ, Schneier F, Gerber A, Barber JP, Chambless DL, Neria Y, Milrod B, Markowitz JC. Anterior hippocampal volume predicts affect-focused psychotherapy outcome. Psychol Med. 2020 Feb;50(3):396-402. doi: 10.1017/S0033291719000187. Epub 2019 Feb 18.
Results Reference
derived
PubMed Identifier
30256548
Citation
McCarthy KS, Chambless DL, Solomonov N, Milrod B, Barber JP. Twelve-Month Outcomes Following Successful Panic-Focused Psychodynamic Psychotherapy, Cognitive-Behavioral Therapy, or Applied Relaxation Training for Panic Disorder. J Clin Psychiatry. 2018 Sep 11;79(5):17m11807. doi: 10.4088/JCP.17m11807.
Results Reference
derived
PubMed Identifier
29336228
Citation
Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.
Results Reference
derived

Learn more about this trial

Comparison of Psychotherapy Programs to Treat Panic Disorder

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