LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction
This study is currently recruiting participants.
Verified April 2012 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Albert Einstein College of Medicine of Yeshiva University
Collaborator:
Information provided by (Responsible Party):
Jonathan Feldman, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01583296
First received: April 19, 2012
Last updated: April 23, 2012
Last verified: April 2012
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Purpose
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 | Intervention |
|---|---|
|
Asthma Panic Disorder |
Behavioral: Music Relaxation Therapy (MRT) Behavioral: Cognitive Behavioral Therapy (CBT) and heart rate variability biofeedback |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Adaptation of a Behavioral Treatment for Latinos With Panic Disorder and Asthma |
Resource links provided by NLM:
Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:
Primary Outcome Measures:
- Panic Disorder Severity Scale [ Time Frame: Change from Pre-Intevention to Post-Intervention (8 weeks) ] [ Designated as safety issue: No ]
- quick-relief medication for asthma [ Time Frame: Change from Pre-Intevention to Post-Intervention (8 weeks) ] [ Designated as safety issue: No ]frequency of use of quick-relief medication for asthma
Secondary Outcome Measures:
- Asthma Control Questionnaire [ Time Frame: Change from Pre-Intevention to Post-Intervention (8 weeks) ] [ Designated as safety issue: No ]
- Clinical Global Impression Scale [ Time Frame: Change from Pre-Intevention to Post-Intervention (8 weeks) ] [ Designated as safety issue: No ]
- adherence with controller medications for asthma [ Time Frame: Change from Pre-Intevention to Post-Intervention (8 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CBT and HRV biofeedback
cognitive behavioral therapy and heart rate variability biofeedback
|
Behavioral: Cognitive Behavioral Therapy (CBT) and heart rate variability biofeedback
cognitive behavioral therapy and heart rate variability biofeedback
|
|
Active Comparator: MRT
music relaxation therapy: music relaxation and breathing at resting respiration rate
|
Behavioral: Music Relaxation Therapy (MRT)
music relaxation therapy and breathing at resting respiration rate
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583296
Locations
| United States, New York | |
| Jacobi Medical Center/North Central Bronx Hospital (NBHN) | Recruiting |
| Bronx, New York, United States | |
| Contact: Jonathan Feldman, Ph.D. 718-430-3968 Jonathan.Feldman@einstein.yu.edu | |
| Principal Investigator: Jonathan Feldman, Ph.D. | |
| Montefiore Medical Center: Moses Division/Weiler Division | Recruiting |
| Bronx, New York, United States | |
| Contact: Jonathan Feldman, Ph.D. 718-430-3968 Jonathan.Feldman@einstein.yu.edu | |
| Principal Investigator: Jonathan Feldman, Ph.D. | |
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
More Information
No publications provided
| Responsible Party: | Jonathan Feldman, Associate Professor of Psychology, Albert Einstein College of Medicine of Yeshiva University |
| ClinicalTrials.gov Identifier: | NCT01583296 History of Changes |
| Other Study ID Numbers: | 2009-223, R34MH087679 |
| Study First Received: | April 19, 2012 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government United States: Data and Safety Monitoring Board |
Additional relevant MeSH terms:
|
Panic Disorder Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013