AsthmaLUCHARNCT01583296
LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction
A study testing Music Relaxation Therapy (MRT) and CBT and HRVB in people with Asthma and Panic Disorder, run by Albert Einstein College of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Panic Disorder
- What is being tested?
- Music Relaxation Therapy (MRT) and CBT and HRVB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jacobi Medical Center/North Central Bronx Hospital (NBHN)
The Bronx, New York, 10467
Montefiore Medical Center: Moses Division/Weiler Division
The Bronx, New York, 10467
About this study
Official title: Adaptation of a Behavioral Treatment for Latinos With Panic Disorder/Asthma
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.
Read the 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.
- Conditions
- Asthma, Panic Disorder
- Being tested
- Music Relaxation Therapy (MRT), CBT and HRVB
- Medical subject headings
- Asthma, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Relaxation Therapy (MRT)Behavioural
music relaxation therapy and breathing at resting respiration rate
CBT and HRVBBehavioural
cognitive behavioral therapy and heart rate variability biofeedback
| Study group | Role | What they receive |
|---|---|---|
| CBT and HRVB | Experimental | Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB) Receives: Behavioral: CBT and HRVB |
| Music Relaxation Therapy (MRT) | Active comparator | Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate Receives: Behavioral: Music Relaxation Therapy (MRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Change from Baseline to Post-Intervention (8 weeks)
Secondary outcomes (2)
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).
Measured: 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.
Measured: Change from Baseline to Post-Intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJul 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jonathan Feldman, Albert Einstein College of Medicine
- Investigators
- Jonathan Feldman, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583296
- Sponsor's protocol ID
- 2009-223
- Other IDs
- R34MH087679
- Acronym
- LUCHAR
- Status last verified
- Sep 2022
- First submitted
- 19 Apr 2012
- Last updated
- 5 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Behavioral Treatment for Latinos With Panic Disorder/Asthma
- ClinicalTrials.gov ID
- NCT01583296
- Acronym / sponsor ID
- LUCHAR / 2009-223
- Conditions
- Asthma, Panic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Posted 18 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT and HRVB | Experimental | Behavioral: CBT and HRVBCognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB) |
| Music Relaxation Therapy (MRT) | Active comparator | Behavioral: Music Relaxation Therapy (MRT)Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Relaxation Therapy (MRT)music relaxation therapy and breathing at resting respiration rate | Behavioural | Music Relaxation Therapy (MRT) |
| CBT and HRVBcognitive behavioral therapy and heart rate variability biofeedback | Behavioural | CBT and HRVB |
Primary outcome
Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale
Time frame: 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
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Asthma Control Questionnaire (ACQ)
Time frame: Change from Baseline to Post-Intervention (8 weeks)
Medication Adherence Report Scale (Adherence to Controller Medications for Asthma)
Time frame: Change from Baseline to Post-Intervention (8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Feldman, PhD principal investigator
Albert Einstein College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Relaxation Therapy (MRT) and CBT and HRVB in people with Asthma and Panic Disorder, run by Albert Einstein College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale (time frame: Baseline, Post-Treatment (end of week 8)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.