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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH070664 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive panic focused psychodynamic psychotherapy for 12 weeks |
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| 2 | Active Comparator | Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks |
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| 3 | Active Comparator | Participants will receive applied relaxation training for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral | CBT for panic disorder will include 19 to 24 sessions over 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Panic Disorder Severity Scale | A composite score of panic severity. High value = 28, lowest value =0. Higher=worse | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sheehan Disability Scale | Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction | 12 weeks |
| Clinical Global Impressions Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Milrod, MD | Weill Medical College of Cornell University | Principal Investigator |
| Jacques P. Barber, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Medical College of Cornell University | New York | New York | 10065 | United States | ||
| University of Pennsylvania School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17267789 | Background | 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. | |
| 17592913 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PFPP | Participants will receive panic focused psychodynamic psychotherapy for 12 weeks Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks. |
| FG001 | C.B.T. | Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks. |
| FG002 | A.R.T. | Participants will receive applied relaxation training for 12 weeks Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PFPP | Participants will receive panic focused psychodynamic psychotherapy for 12 weeks Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks. |
| BG001 | C.B.T. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Panic Disorder Severity Scale | A composite score of panic severity. High value = 28, lowest value =0. Higher=worse | one subject was eliminated from analyses with DSMB consent as they lied about symptoms at intake and did not meet inclusion criteria | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
Subjects assessed for AEs for three months of therapy, 3 months of crossover (if eligible) and 12 months of follow-up; 15-18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PFPP | Participants will receive panic focused psychodynamic psychotherapy for 12 weeks Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Psychiatric disorders | patient history | Non-systematic Assessment | Psychiatric hospitalization required-1 pt with PTSD and depression; 1 pt developed psychotic depression |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Milrod, M.D., PI | Albert Einstein College of Medicine | 212-595-0806 | bmilrod@montefiore.org |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D016584 | Panic Disorder |
| D000379 | Agoraphobia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Applied relaxation training (ART) | Behavioral | ART with exposure protocol will include 19 to 24 sessions over 12 weeks. |
|
|
| Panic focused psychodynamic psychotherapy (PFPP) | Behavioral | PFPP will include 19 to 24 sessions over 12 weeks. |
|
Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
| 12 weeks |
| Hamilton Depression Rating Scale | Level of state depression. scale 0-81, 0 symptom free, 81 worst severity | 12 weeks |
| Hamilton Anxiety Rating Scale | level of state anxiety. 0=symptom free, 56 most severe | 12 weeks |
| 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 |
| 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 |
| Panic-Specific Reflective Function | Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better | 12 weeks |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| 27464313 | Result | 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. |
| 32584211 | Derived | 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. |
| 32105128 | Derived | 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. |
| 30869969 | Derived | 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. |
| 30821630 | Derived | 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. |
| 30773148 | Derived | 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. |
| 30256548 | Derived | 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. |
| 29336228 | Derived | 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. |
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
| BG002 | A.R.T. | Participants will receive applied relaxation training for 12 weeks Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | A.R.T. | Participants will receive applied relaxation training for 12 weeks Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks. |
|
|
|
| Secondary | Sheehan Disability Scale | Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction | Data is presented for those subjects from whom data was collected for this measure. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Clinical Global Impressions Scale | Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse | Data is presented for those subjects from whom data was collected for this measure. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Hamilton Depression Rating Scale | Level of state depression. scale 0-81, 0 symptom free, 81 worst severity | Data is presented for those subjects from whom data was collected for this measure. | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| Secondary | Hamilton Anxiety Rating Scale | level of state anxiety. 0=symptom free, 56 most severe | Data is presented for those subjects from whom data was collected for this measure. | Posted | Mean | Standard Deviation | units on a scale | 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 | Data is presented for those subjects from whom data was collected for this measure. | Posted | Mean | Standard Deviation | score on a scale | 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 | Data is presented for those subjects from whom data was collected for this measure. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Panic-Specific Reflective Function | Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better | Data is presented for those subjects from whom data was collected for this measure. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | C.B.T. | Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks. | 0 | 81 | 0 | 81 | 0 | 81 |
| EG002 | A.R.T. | Participants will receive applied relaxation training for 12 weeks Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks. | 0 | 39 | 2 | 39 | 0 | 39 |
|
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