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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH087679 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The research plan involves two aims: 1) Cultural adaptation of the Panic-Asthma Treatment and 2) a randomized, placebo-controlled pilot study. Participants will be primarily recruited from two major, inner-city hospitals in the Bronx, NY. Diagnosis of Panic Disorder (PD) will be based on the Structured Clinical Interview for DSM-IV. Diagnosis of asthma will be based on national guidelines. The first year of the project will be devoted to approximately 5 focus groups with Latino (primarily Puerto Rican) participants, pilot treatment and participant feedback. The protocol will be adapted based on key cultural issues that are systematically observed during Phase 1. During Years 2-3, 40 participants with PD and asthma will be randomized into two treatment arms: Panic-Asthma Treatment and an active placebo condition involving music therapy and paced breathing at resting respiration rates. Each treatment will involve 8 weekly sessions. An interviewer, who will be blind to treatment condition, will conduct assessments at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up. The primary hypotheses are that participants in the Panic-Asthma treatment group will have greater decreases than subjects in the placebo condition on the PD severity scale and albuterol use (i.e., rescue asthma medication) from pre-test to post-test and across 3-month follow-up.
Asthma and panic disorder (PD) share strikingly similar phenomenology. Respiratory related symptoms, such as dyspnea, dizziness, chest tightness, feelings of choking and sensations of smothering are common in both disorders. The overlap in symptoms between asthma and panic may lead an individual to mistake a panic attack as an asthma attack. In order to better understand this overlap, we hypothesized that participants who received Cognitive Behavioral Psychophysiological Therapy (CBPT) would display greater reductions in PD severity and improvements in asthma control at post- treatment and 3-month follow-up. We predicted that improvements in PD severity in the CBPT group would be mediated by reductions in the perceived physical consequences of anxiety. We selected music therapy and paced breathing at each participant's average respiration rate for the comparison active treatment. Randomized participants will undergo either the CBPT or MRT protocol, be given the same psychological assessments, and have their physiological data collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT and HRVB | Experimental | Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB) |
|
| Music Relaxation Therapy (MRT) | Active Comparator | Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Relaxation Therapy (MRT) | Behavioral | music relaxation therapy and breathing at resting respiration rate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale | The Panic Disorder Severity Scale (PDSS) is a clinician-administered questionnaire used to assess the severity of panic attacks. The PDSS consists of seven items with each ranging in severity from 0 (none) - 4 (extreme); so total score ranges from 0 to 28. | Baseline, Post-Treatment (end of week 8) |
| Asthma Control Based on Rescue Medication Use | Dosers (electronic devices used to monitor the usage of metered-dose inhalers) were attached to participants' asthma rescue inhalers to count the number of puffs of medication used during the treatment period. Use of rescue medication was then coded as good asthma control (less than or equal to rescue medication use twice a week) or poor control (rescue medication use greater than two days a week) in accordance with national guidelines (NHLBI, 2007). | Change from Baseline to Post-Intervention (8 weeks) |
| Clinical Global Impression Scale (CGI) | The CGI is a 2-item scale rated by clinicians to assesses for a patient's functioning prior and subsequent to the implementation of an intervention. In the current study, the CGI was used to assess panic disorder illness severity in patients as well as identify whether subjects responded to the study intervention. The CGI scale includes a question on level of improvement subsequent to intervention ranging from 1 (very much improved) to 7 (very much worse), and a question on severity of illness ranging from 1 (normal) to 6 (among the most extremely ill of patients). To be a treatment responder, a participant had to have a score of 2 (much improved) or better and be rated as a 3 (mild) or less on their illness severity. | Change from Baseline to Post-Intervention (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire (ACQ) | The ACQ is a self-report questionnaire to assess asthma control based on asthma symptoms, nighttime awakenings, and use of rescue medication for asthma. Each item is given a score from 0 to 6 with lower scores indicating better asthma control. The ACQ total scale score is an average of the item questions, with scores ranging between 0 (well controlled) and 6 (extremely poorly controlled). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Feldman, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center/North Central Bronx Hospital (NBHN) | The Bronx | New York | 10467 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT and HRVB | Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB) CBT and HRVB: cognitive behavioral therapy and heart rate variability biofeedback |
| FG001 | Music Relaxation Therapy (MRT) | Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate Music Relaxation Therapy (MRT): music relaxation therapy and breathing at resting respiration rate |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, in each of the study arms 24 participants completed the baseline session.
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT and HRVB | Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB) |
| BG001 | Music Relaxation Therapy (MRT) | Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale | The Panic Disorder Severity Scale (PDSS) is a clinician-administered questionnaire used to assess the severity of panic attacks. The PDSS consists of seven items with each ranging in severity from 0 (none) - 4 (extreme); so total score ranges from 0 to 28. | While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, outcome measures were analyzed for the 48 participants (24 in each arm) that completed their baseline sessions. | Posted | Mean | Standard Error | score on a scale | Baseline, Post-Treatment (end of week 8) |
|
Data on participant adverse events were collected over the course of approximately 3 months, from the participant's baseline session to their 3- month follow-up session.
The study utilized the clinicaltrials.gov definition of adverse events. At each study session participants were asked if any adverse events had occurred since the last study session, with the PI reporting any deaths and serious events (within 48 hours of PI's knowledge) and Unanticipated Events (within 30 days of PI's knowledge) to the IRB committee.
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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 | CBT and HRVB | Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB) |
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The main limitations of this study were the small sample size and high drop-out rate (40%). The MARS was not applicable to 25% of participants who were not taking ICS medications. The use of %FEV1 as the sole measure of pulmonary function was limited by its snapshot measure of asthma control. Finally, the findings of this study are specific to a narrow sample of Latinos and may not generalize.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan M. Feldman | Ferkauf Graduate School of Psychology, Yeshiva University | 6465924508 | jonathan.feldman@einstein.yu.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| CBT and HRVB | Behavioral | cognitive behavioral therapy and heart rate variability biofeedback |
|
| Change from Baseline to Post-Intervention (8 weeks) |
| Medication Adherence Report Scale (Adherence to Controller Medications for Asthma) | Self-report measure of adherence to controller medications with 10 items ranging from 1 (always) to 5 (never). Higher mean scores indicate greater adherence and a score > 4.5 is considered good adherence. | Change from Baseline to Post-Intervention (8 weeks) |
| Montefiore Medical Center: Moses Division/Weiler Division |
| The Bronx |
| New York |
| 10467 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Household Income | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Health Insurance | Count of Participants | Participants |
|
| Cigarette Smoking History | Count of Participants | Participants |
|
| Asthma Severity | Count of Participants | Participants |
|
| Language | Count of Participants | Participants |
|
| OG001 | Music Relaxation Therapy (MRT) | Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate |
|
|
| Primary | Asthma Control Based on Rescue Medication Use | Dosers (electronic devices used to monitor the usage of metered-dose inhalers) were attached to participants' asthma rescue inhalers to count the number of puffs of medication used during the treatment period. Use of rescue medication was then coded as good asthma control (less than or equal to rescue medication use twice a week) or poor control (rescue medication use greater than two days a week) in accordance with national guidelines (NHLBI, 2007). | While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, outcome measures were analyzed for the 48 participants (24 in each arm) that completed their baseline sessions. | Posted | Mean | Standard Error | % good asthma control | Change from Baseline to Post-Intervention (8 weeks) |
|
|
|
| Primary | Clinical Global Impression Scale (CGI) | The CGI is a 2-item scale rated by clinicians to assesses for a patient's functioning prior and subsequent to the implementation of an intervention. In the current study, the CGI was used to assess panic disorder illness severity in patients as well as identify whether subjects responded to the study intervention. The CGI scale includes a question on level of improvement subsequent to intervention ranging from 1 (very much improved) to 7 (very much worse), and a question on severity of illness ranging from 1 (normal) to 6 (among the most extremely ill of patients). To be a treatment responder, a participant had to have a score of 2 (much improved) or better and be rated as a 3 (mild) or less on their illness severity. | While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, outcome measures were analyzed for the 48 participants (24 in each arm) that completed their baseline sessions. | Posted | Count of Participants | Participants | Change from Baseline to Post-Intervention (8 weeks) |
|
|
|
| Secondary | Asthma Control Questionnaire (ACQ) | The ACQ is a self-report questionnaire to assess asthma control based on asthma symptoms, nighttime awakenings, and use of rescue medication for asthma. Each item is given a score from 0 to 6 with lower scores indicating better asthma control. The ACQ total scale score is an average of the item questions, with scores ranging between 0 (well controlled) and 6 (extremely poorly controlled). | While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, outcome measures were analyzed for the 48 participants (24 in each arm) that completed their baseline sessions. | Posted | Mean | Standard Error | natural log transformed score on a scale | Change from Baseline to Post-Intervention (8 weeks) |
|
|
|
| Secondary | Medication Adherence Report Scale (Adherence to Controller Medications for Asthma) | Self-report measure of adherence to controller medications with 10 items ranging from 1 (always) to 5 (never). Higher mean scores indicate greater adherence and a score > 4.5 is considered good adherence. | Posted | Mean | Standard Error | score on a scale | Change from Baseline to Post-Intervention (8 weeks) |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Music Relaxation Therapy (MRT) | Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate | 0 | 24 | 0 | 24 | 0 | 24 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |