Clinical Trials Directory

Trials / Completed

CompletedNCT01583296

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

Adaptation of a Behavioral Treatment for Latinos With Panic Disorder/Asthma

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
53 (actual)
Sponsor
Albert Einstein College of Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMusic Relaxation Therapy (MRT)music relaxation therapy and breathing at resting respiration rate
BEHAVIORALCBT and HRVBcognitive behavioral therapy and heart rate variability biofeedback

Timeline

Start date
2010-07-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2012-04-24
Last updated
2022-10-05
Results posted
2021-11-18

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01583296. Inclusion in this directory is not an endorsement.