N/A
N=53
LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction
Asthma · Panic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01583296 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale — 2.17; 2.40; 1.64; 1.52 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Music Relaxation Therapy (MRT) (Behavioral); CBT and HRVB (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale |
2.17; 2.40; 1.64; 1.52 | — |
| PRIMARY Asthma Control Based on Rescue Medication Use |
28.99; 23.24; 55.42; 51.48 | — |
| PRIMARY Clinical Global Impression Scale (CGI) |
7; 5; 17; 19 | — |
| SECONDARY Asthma Control Questionnaire (ACQ) |
0.85; 0.85; 0.22; 0.46 | — |
| SECONDARY Medication Adherence Report Scale (Adherence to Controller Medications for Asthma) |
3.51; 4.38; 4.15; 4.40 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01583296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.