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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 : February 16, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jonathan Feldman, Albert Einstein College of Medicine, Inc.

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.

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. Panic Disorder Severity Scale [ Time Frame: Change from Baseline to Post-Intervention (8 weeks) ]
    A self-report measure used to assess the severity and frequency of panic attacks

  2. Quick-Relief Medication for Asthma [ Time Frame: Change from Baseline to Post-Intervention (8 weeks) ]
    Frequency of use of quick-relief medication for asthma


Secondary Outcome Measures :
  1. Asthma Control Questionnaire [ Time Frame: Change from Baseline to Post-Intervention (8 weeks) ]
    Self-report questionnaire for adolescents and parents to assess asthma management

  2. Clinical Global Impression Scale [ Time Frame: Change from Baseline to Post-Intervention (8 weeks) ]
    Scale used by clinicians to rate illness severity in patients

  3. Adherence with Controller Medications for Asthma [ Time Frame: Change from Baseline to Post-Intervention (8 weeks) ]
    Percentage of total doses taken per day/prescribed per day



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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
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, Inc.
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jonathan Feldman, PhD Albert Einstein College of Medicine, Inc.

Responsible Party: Jonathan Feldman, Associate Professor of Psychology, Albert Einstein College of Medicine, Inc.
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: February 16, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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