Clinical trial NCT01583296: LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction
Official title: Adaptation of a Behavioral Treatment for Latinos With Panic Disorder/Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Panic Disorder
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-04-24
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale
timeFrame: Baseline, Post-Treatment (end of week 8)
measure: Asthma Control Based on Rescue Medication Use
timeFrame: Change from Baseline to Post-Intervention (8 weeks)
measure: Clinical Global Impression Scale (CGI)
timeFrame: Change from Baseline to Post-Intervention (8 weeks)
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ)
timeFrame: Change from Baseline to Post-Intervention (8 weeks)
measure: Medication Adherence Report Scale (Adherence to Controller Medications for Asthma)
timeFrame: Change from Baseline to Post-Intervention (8 weeks)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center/North Central Bronx Hospital (NBHN)
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center: Moses Division/Weiler Division
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Jonathan Feldman, PhD
role: PRINCIPAL_INVESTIGATOR
References: