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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jonathan Feldman, Albert Einstein College of Medicine

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jonathan Feldman, PhD Albert Einstein College of Medicine

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Responsible Party: Jonathan Feldman, Associate Professor of Psychology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01583296     History of Changes
Other Study ID Numbers: 2009-223
R34MH087679 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Asthma
Panic Disorder
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anxiety Disorders
Mental Disorders