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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Music Relaxation Therapy (MRT) | music relaxation therapy and breathing at resting respiration rate |
| BEHAVIORAL | CBT and HRVB | cognitive 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.