Asthma, Panic Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMusic Relaxation Therapy (MRT)
music relaxation therapy and breathing at resting respiration rate
BEHAVIORALCBT and HRVB
cognitive behavioral therapy and heart rate variability biofeedback
Sponsors
National Institute of Mental Health (NIMH)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* DSM-IV criteria for current PD with or without agoraphobia * fluency in spoken English or Spanish * no changes in prescribed levels of panicolytic medication for two months prior to the study and no changes in panicolytic medication during the two months of the active protocol * history or presence of episodic symptoms of airflow obstruction, namely, wheezing, shortness of breath, chest tightness, or cough * airflow obstruction showing FEV1 \< 80% predicted and FEV1/FVC \< 65% or below the lower limit of normal * airflow obstruction must be at least partly reversible, as demonstrated by: * Positive Bronchodilator test in past year from Medical Chart Review or Baseline session * Positive Bronchodilator test during past 10 years (from Medical Chart Review) and asthma symptoms reported past 12 months (from Medical Chart Review or Baseline Questionnaires) * Improvement in PEF of ≥20% from Medical Chart Review past 10 years (from Medical Chart Review) and asthma symptoms reported past 12 months (from Medical Chart Review or Baseline Questionnaires) * Clinical improvement in asthma symptoms after initiation of anti-inflammatory medication, as documented in medical records.
Exclusion criteria
* evidence of active bipolar disorder or psychosis * mental retardation or organic brain syndrome * current alcohol or substance abuse/dependence * foreign body aspiration, vocal cord dysfunction, or other pulmonary diseases * history of smoking 20 pack-years or more * history consistent with emphysema, sarcoidosis, bronchiectasis, pulmonary tuberculosis, lung cancer, cardiovascular or neurological disease * current participation in alternative psychotherapy for anxiety or panic for less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale | Baseline, Post-Treatment (end of week 8) | 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. |
| Asthma Control Based on Rescue Medication Use | Change from Baseline to Post-Intervention (8 weeks) | 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). |
| Clinical Global Impression Scale (CGI) | Change from Baseline to Post-Intervention (8 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Questionnaire (ACQ) | Change from Baseline to Post-Intervention (8 weeks) | 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). |
| Medication Adherence Report Scale (Adherence to Controller Medications for Asthma) | Change from Baseline to Post-Intervention (8 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT and HRVB Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB) | 24 |
| Music Relaxation Therapy (MRT) Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 11 | 10 |
Baseline characteristics
| Characteristic | CBT and HRVB | Music Relaxation Therapy (MRT) | Total |
|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 11.8 | 42.6 years STANDARD_DEVIATION 12.9 | 43.2 years STANDARD_DEVIATION 12.3 |
| Asthma Severity Intermittent/Mild Persistent | 3 Participants | 4 Participants | 7 Participants |
| Asthma Severity Moderate Persistent | 19 Participants | 19 Participants | 38 Participants |
| Asthma Severity Severe Persistent | 2 Participants | 1 Participants | 3 Participants |
| Cigarette Smoking History Current Smoker | 5 Participants | 6 Participants | 11 Participants |
| Cigarette Smoking History Ex-Smoker | 6 Participants | 3 Participants | 9 Participants |
| Cigarette Smoking History Never Smoked | 13 Participants | 15 Participants | 28 Participants |
| Education At least some college | 8 Participants | 14 Participants | 22 Participants |
| Education High School | 6 Participants | 7 Participants | 13 Participants |
| Education Less than high school | 10 Participants | 3 Participants | 13 Participants |
| Employment Status Employed or Student | 9 Participants | 9 Participants | 18 Participants |
| Employment Status Unemployed | 15 Participants | 15 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 24 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Health Insurance Medicaid or Medicare | 21 Participants | 20 Participants | 41 Participants |
| Health Insurance Other | 3 Participants | 4 Participants | 7 Participants |
| Household Income < $16000 | 14 Participants | 10 Participants | 24 Participants |
| Household Income >$16000 | 10 Participants | 14 Participants | 24 Participants |
| Language English | 20 Participants | 17 Participants | 37 Participants |
| Language Spanish | 4 Participants | 7 Participants | 11 Participants |
| Marital Status Married | 6 Participants | 5 Participants | 11 Participants |
| Marital Status Never married | 11 Participants | 11 Participants | 22 Participants |
| Marital Status Separated/Divorced/Widowed | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States Continental US-Born | 14 Participants | 13 Participants | 27 Participants |
| Region of Enrollment United States Non-Continental US-Born | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
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).
Time frame: Change from Baseline to Post-Intervention (8 weeks)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT and HRVB | Asthma Control Based on Rescue Medication Use | Baseline | 28.99 % good asthma control | Standard Error 10.69 |
| CBT and HRVB | Asthma Control Based on Rescue Medication Use | Post-Treatment | 55.42 % good asthma control | Standard Error 12.83 |
| Music Relaxation Therapy (MRT) | Asthma Control Based on Rescue Medication Use | Baseline | 23.24 % good asthma control | Standard Error 9.69 |
| Music Relaxation Therapy (MRT) | Asthma Control Based on Rescue Medication Use | Post-Treatment | 51.48 % good asthma control | Standard Error 13.36 |
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.
Time frame: Baseline, Post-Treatment (end of week 8)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT and HRVB | Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale | Baseline | 2.17 score on a scale | Standard Error 0.16 |
| CBT and HRVB | Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale | Post-Treatment | 1.64 score on a scale | Standard Error 0.18 |
| Music Relaxation Therapy (MRT) | Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale | Baseline | 2.40 score on a scale | Standard Error 0.17 |
| Music Relaxation Therapy (MRT) | Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale | Post-Treatment | 1.52 score on a scale | Standard Error 0.19 |
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.
Time frame: Change from Baseline to Post-Intervention (8 weeks)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CBT and HRVB | Clinical Global Impression Scale (CGI) | Responders | 7 Participants |
| CBT and HRVB | Clinical Global Impression Scale (CGI) | Non-Responders | 17 Participants |
| Music Relaxation Therapy (MRT) | Clinical Global Impression Scale (CGI) | Responders | 5 Participants |
| Music Relaxation Therapy (MRT) | Clinical Global Impression Scale (CGI) | Non-Responders | 19 Participants |
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).
Time frame: Change from Baseline to Post-Intervention (8 weeks)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT and HRVB | Asthma Control Questionnaire (ACQ) | Baseline | 0.85 natural log transformed score on a scale | Standard Error 0.14 |
| CBT and HRVB | Asthma Control Questionnaire (ACQ) | Post-Treatment | 0.22 natural log transformed score on a scale | Standard Error 0.17 |
| Music Relaxation Therapy (MRT) | Asthma Control Questionnaire (ACQ) | Baseline | 0.85 natural log transformed score on a scale | Standard Error 0.15 |
| Music Relaxation Therapy (MRT) | Asthma Control Questionnaire (ACQ) | Post-Treatment | 0.46 natural log transformed score on a scale | Standard Error 0.18 |
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.
Time frame: Change from Baseline to Post-Intervention (8 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT and HRVB | Medication Adherence Report Scale (Adherence to Controller Medications for Asthma) | Baseline | 3.51 score on a scale | Standard Error 0.17 |
| CBT and HRVB | Medication Adherence Report Scale (Adherence to Controller Medications for Asthma) | Post-Treatment | 4.15 score on a scale | Standard Error 0.17 |
| Music Relaxation Therapy (MRT) | Medication Adherence Report Scale (Adherence to Controller Medications for Asthma) | Baseline | 4.38 score on a scale | Standard Error 0.18 |
| Music Relaxation Therapy (MRT) | Medication Adherence Report Scale (Adherence to Controller Medications for Asthma) | Post-Treatment | 4.40 score on a scale | Standard Error 0.2 |