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

Albert Einstein College of Medicine logo

Albert Einstein College of Medicine

Status

Completed

Conditions

Asthma
Panic Disorder

Treatments

Behavioral: CBT and HRVB
Behavioral: Music Relaxation Therapy (MRT)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01583296
R34MH087679 (U.S. NIH Grant/Contract)
2009-223

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

53 participants in 2 patient groups

CBT and HRVB
Experimental group
Description:
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
Treatment:
Behavioral: CBT and HRVB
Music Relaxation Therapy (MRT)
Active Comparator group
Description:
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Treatment:
Behavioral: Music Relaxation Therapy (MRT)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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