A Phase 3 interventional study of Cognitive behavioral therapy and Applied relaxation training (ART) in Anxiety Disorders, Panic Disorder and Agoraphobia, sponsored by Weill Medical College of Cornell University. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by Weill Medical College of Cornell University · Phase 3, Interventional, and Treatment
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 201 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Behavioral: Panic focused psychodynamic psychotherapy (PFPP)
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Behavioral: Cognitive behavioral therapy
Participants will receive applied relaxation training for 12 weeks
Behavioral: Applied relaxation training (ART)
CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
Also known as: Panic control treatment
ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
Also known as: ART
PFPP will include 19 to 24 sessions over 12 weeks.
Panic Disorder Severity Scale
A composite score of panic severity. High value = 28, lowest value =0. Higher=worse
Time frame: 12 weeks
Sheehan Disability Scale
Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction
Time frame: 12 weeks
Clinical Global Impressions Scale
Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
Time frame: 12 weeks
Hamilton Depression Rating Scale
Level of state depression. scale 0-81, 0 symptom free, 81 worst severity
Time frame: 12 weeks
Hamilton Anxiety Rating Scale
level of state anxiety. 0=symptom free, 56 most severe
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Panic-Specific Reflective Function
Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better
Time frame: 12 weeks
| Milestone | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Started | 81 | 81 | 39 |
| Completed | 61 | 61 | 23 |
| Not completed | 20 | 20 | 16 |
A composite score of panic severity. High value = 28, lowest value =0. Higher=worse
| score on a scale | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Panic Disorder Severity Scale | 6.72 ± 4.49 | 5.78 ± 3.48 | 7 ± 2.94 |
Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction
| score on a scale | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Sheehan Disability Scale | 6.4 ± 6.74 | 6.28 ± 5.89 | 6.9 ± 4.43 |
Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
| units on a scale | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Clinical Global Impressions Scale | 2.17 ± 1.28 | 2.16 ± 0.90 | 2.38 ± 0.92 |
Level of state depression. scale 0-81, 0 symptom free, 81 worst severity
| units on a scale | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Hamilton Depression Rating Scale | 11.37 (0 to 81) | 10.18 (0 to 81) | 11.55 (0 to 81) |
level of state anxiety. 0=symptom free, 56 most severe
| units on a scale | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Hamilton Anxiety Rating Scale | 7.97 ± 6.13 | 7.87 ± 5.89 | 6.30 ± 3.2 |
Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety
| score on a scale | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Anxiety Disorder Sensitivity Index | 27.07 ± 12.77 | 17.71 ± 9.87 | 19.09 ± 12.28 |
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
| score on a scale | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Brief Body Sensitivity Interpretation Questionnaire (BBSIQ) | 1.80 ± 0.39 | 1.62 ± 0.31 | 1.70 ± 0.27 |
Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better
| units on a scale | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| Panic-Specific Reflective Function | 4.67 ± 1.11 | 3.67 ± 1.15 | 3.20 ± 1.03 |
Collected over Subjects assessed for AEs for three months of therapy, 3 months of crossover (if eligible) and 12 months of follow-up; 15-18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PFPP | 0/81 (0%) | 0/81 (0%) | 0/81 (0%) |
| C.B.T. | 0/81 (0%) | 0/81 (0%) | 0/81 (0%) |
| A.R.T. | 0/39 (0%) | 2/39 (5.1%) | 0/39 (0%) |
| Event | PFPP | C.B.T. | A.R.T. |
|---|---|---|---|
| hospitalizationPsychiatric disorders | 0/81 | 0/81 | 2/2 |
| Age, Categorical(Participants) | PFPP | C.B.T. | A.R.T. | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 81 | 81 | 39 | 201 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | PFPP | C.B.T. | A.R.T. | Total |
|---|---|---|---|---|
| Mean | 39.8 ± 13.2 | 39.3 ± 12.9 | 36 ± 12 | 38.8 ± 13.2 |
| Sex: Female, Male(Participants) | PFPP | C.B.T. | A.R.T. | Total |
|---|---|---|---|---|
| Female | 58 | 46 | 32 | 136 |
| Male | 23 | 35 | 7 | 65 |
| Region of Enrollment(participants) | PFPP | C.B.T. | A.R.T. | Total |
|---|---|---|---|---|
| United States | 81 | 81 | 39 | 201 |
The record gives a start of Sep 2006, a primary completion of Mar 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2022, 10 years 9 months after primary completion.
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