LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction

• Sponsor: Albert Einstein College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01583296
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 53
• Locations: 2
• Arms: 2
• Duration (Months): 41
• Patients Per Site: 26.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Panic Disorder	Behavioral: Music Relaxation Therapy (MRT); Behavioral: CBT and HRVB	N/A

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

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Adaptation of a Behavioral Treatment for Latinos With Panic Disorder and Asthma
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBT and HRVB Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)	Behavioral: CBT and HRVB; cognitive behavioral therapy and heart rate variability biofeedback
Active Comparator: Music Relaxation Therapy (MRT) Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate	Behavioral: Music Relaxation Therapy (MRT); music relaxation therapy and breathing at resting respiration rate

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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).

3. 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 Outcome Measures

1. 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).

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jacobi Medical Center/North Central Bronx Hospital (NBHN)	Bronx	New York	United States	10467
2	Montefiore Medical Center: Moses Division/Weiler Division	Bronx	New York	United States	10467

Sponsors and Collaborators

• Albert Einstein College of Medicine
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Jonathan Feldman, PhD, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonathan Feldman, Associate Professor of Psychology, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT01583296
• Other Study ID Numbers: 2009-223; R34MH087679
• First Posted: Apr 24, 2012
• Last Update Posted: Nov 18, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Asthma; Panic Disorder

Study Results

Participant Flow

Arm/Group Title	CBT and HRVB	Music Relaxation Therapy (MRT)
Arm/Group Description	Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB) CBT and HRVB: cognitive behavioral therapy and heart rate variability biofeedback	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
Period Title: Overall Study
STARTED	27	26
COMPLETED	16	16
NOT COMPLETED	11	10

Baseline Characteristics

Arm/Group Title	CBT and HRVB	Music Relaxation Therapy (MRT)	Total
Arm/Group Description	Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)	Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate	Total of all reporting groups
Overall Participants	24	24	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.8 (11.8)	42.6 (12.9)	43.2 (12.3)
Sex: Female, Male (Count of Participants)
Female	22 91.7%	23 95.8%	45 93.8%
Male	2 8.3%	1 4.2%	3 6.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	24 100%	24 100%	48 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Continental US-Born	14 58.3%	13 54.2%	27 56.3%
Non-Continental US-Born	10 41.7%	11 45.8%	21 43.8%
Household Income (Count of Participants)
>$16000	10 41.7%	14 58.3%	24 50%
< $16000	14 58.3%	10 41.7%	24 50%
Education (Count of Participants)
At least some college	8 33.3%	14 58.3%	22 45.8%
High School	6 25%	7 29.2%	13 27.1%
Less than high school	10 41.7%	3 12.5%	13 27.1%
Marital Status (Count of Participants)
Married	6 25%	5 20.8%	11 22.9%
Never married	11 45.8%	11 45.8%	22 45.8%
Separated/Divorced/Widowed	7 29.2%	8 33.3%	15 31.3%
Employment Status (Count of Participants)
Employed or Student	9 37.5%	9 37.5%	18 37.5%
Unemployed	15 62.5%	15 62.5%	30 62.5%
Health Insurance (Count of Participants)
Medicaid or Medicare	21 87.5%	20 83.3%	41 85.4%
Other	3 12.5%	4 16.7%	7 14.6%
Cigarette Smoking History (Count of Participants)
Current Smoker	5 20.8%	6 25%	11 22.9%
Ex-Smoker	6 25%	3 12.5%	9 18.8%
Never Smoked	13 54.2%	15 62.5%	28 58.3%
Asthma Severity (Count of Participants)
Intermittent/Mild Persistent	3 12.5%	4 16.7%	7 14.6%
Moderate Persistent	19 79.2%	19 79.2%	38 79.2%
Severe Persistent	2 8.3%	1 4.2%	3 6.3%
Language (Count of Participants)
English	20 83.3%	17 70.8%	37 77.1%
Spanish	4 16.7%	7 29.2%	11 22.9%

Outcome Measures

1. Primary Outcome

Title	Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	CBT and HRVB	Music Relaxation Therapy (MRT)
Arm/Group Description	Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)	Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Measure Participants	24	24
Baseline	2.17 (0.16)	2.40 (0.17)
Post-Treatment	1.64 (0.18)	1.52 (0.19)

2. Primary Outcome

Title	Asthma Control Based on Rescue Medication Use
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	CBT and HRVB	Music Relaxation Therapy (MRT)
Arm/Group Description	Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)	Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Measure Participants	24	24
Baseline	28.99 (10.69)	23.24 (9.69)
Post-Treatment	55.42 (12.83)	51.48 (13.36)

3. Primary Outcome

Title	Clinical Global Impression Scale (CGI)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	CBT and HRVB	Music Relaxation Therapy (MRT)
Arm/Group Description	Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)	Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Measure Participants	24	24
Responders	7 29.2%	5 20.8%
Non-Responders	17 70.8%	19 79.2%

4. Secondary Outcome

Title	Asthma Control Questionnaire (ACQ)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	CBT and HRVB	Music Relaxation Therapy (MRT)
Arm/Group Description	Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)	Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Measure Participants	24	24
Baseline	0.85 (0.14)	0.85 (0.15)
Post-Treatment	0.22 (0.17)	0.46 (0.18)

5. Secondary Outcome

Title	Medication Adherence Report Scale (Adherence to Controller Medications for Asthma)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CBT and HRVB	Music Relaxation Therapy (MRT)
Arm/Group Description	Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)	Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Measure Participants	24	24
Baseline	3.51 (0.17)	4.38 (0.18)
Post-Treatment	4.15 (0.17)	4.40 (0.20)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	CBT and HRVB		Music Relaxation Therapy (MRT)
Arm/Group Description	Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)		Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
All Cause Mortality
	CBT and HRVB		Music Relaxation Therapy (MRT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Serious Adverse Events
	CBT and HRVB		Music Relaxation Therapy (MRT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	CBT and HRVB		Music Relaxation Therapy (MRT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.