LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction (LUCHAR)
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|ClinicalTrials.gov Identifier: NCT01583296|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : July 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthma Panic Disorder||Behavioral: Music Relaxation Therapy (MRT) Behavioral: CBT and HRVB||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Adaptation of a Behavioral Treatment for Latinos With Panic Disorder and Asthma|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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
- 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.
- Frequency of asthma medication use [ Time Frame: Change from Baseline to Post-Intervention (8 weeks) ]Doser devices are electronic devices used to monitor usage of metered-dose inhalers. Doser devices were attached to quick-relief asthma medication inhalers in order to count the number of puffs of medication used during the treatment period.
- Asthma control as measured by the Asthma Control Questionnaire [ Time Frame: Change from Baseline to Post-Intervention (8 weeks) ]Participants are given a self-report questionnaire to assess 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.
- Treatment responder as measured by Clinical Global Impression Scale [ Time Frame: Change from Baseline to Post-Intervention (8 weeks) ]A 2-item scale rated by clinicians to assess panic disorder illness severity in patients and to identify subjects as treatment responders or not. The question on level of improvement ranges from 1 (very much improved) to 7 (very much worse). The question on severity of illness ranges from 1 (normal) to 6 (among the most extremely ill of patients)
- Adherence to controller medications for asthma as measured by the Medication Adherence Report Scale [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583296
|United States, New York|
|Jacobi Medical Center/North Central Bronx Hospital (NBHN)|
|Bronx, New York, United States, 10467|
|Montefiore Medical Center: Moses Division/Weiler Division|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Jonathan Feldman, PhD||Albert Einstein College of Medicine|