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

Asthma Clinical Trial

— LUCHAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583296
• Other study ID #: 2009-223
• Secondary ID: R34MH087679
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: December 2013

Study information

• Verified date: September 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Panic Disorder

Intervention

Behavioral:
• Music Relaxation Therapy (MRT)
music relaxation therapy and breathing at resting respiration rate
• CBT and HRVB
cognitive behavioral therapy and heart rate variability biofeedback

Locations

Country	Name	City	State
United States	Jacobi Medical Center/North Central Bronx Hospital (NBHN)	Bronx	New York
United States	Montefiore Medical Center: Moses Division/Weiler Division	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale	The Panic Disorder Severity Scale (PDSS) is a clinician-administered questionnaire used to assess the severity of panic attacks. The PDSS consists of seven items with each ranging in severity from 0 (none) - 4 (extreme); so total score ranges from 0 to 28.	Baseline, Post-Treatment (end of week 8)
Primary	Asthma Control Based on Rescue Medication Use	Dosers (electronic devices used to monitor the usage of metered-dose inhalers) were attached to participants' asthma rescue inhalers to count the number of puffs of medication used during the treatment period. Use of rescue medication was then coded as good asthma control (less than or equal to rescue medication use twice a week) or poor control (rescue medication use greater than two days a week) in accordance with national guidelines (NHLBI, 2007).	Change from Baseline to Post-Intervention (8 weeks)
Primary	Clinical Global Impression Scale (CGI)	The CGI is a 2-item scale rated by clinicians to assesses for a patient's functioning prior and subsequent to the implementation of an intervention. In the current study, the CGI was used to assess panic disorder illness severity in patients as well as identify whether subjects responded to the study intervention. The CGI scale includes a question on level of improvement subsequent to intervention ranging from 1 (very much improved) to 7 (very much worse), and a question on severity of illness ranging from 1 (normal) to 6 (among the most extremely ill of patients). To be a treatment responder, a participant had to have a score of 2 (much improved) or better and be rated as a 3 (mild) or less on their illness severity.	Change from Baseline to Post-Intervention (8 weeks)
Secondary	Asthma Control Questionnaire (ACQ)	The ACQ is a self-report questionnaire to assess asthma control based on asthma symptoms, nighttime awakenings, and use of rescue medication for asthma. Each item is given a score from 0 to 6 with lower scores indicating better asthma control. The ACQ total scale score is an average of the item questions, with scores ranging between 0 (well controlled) and 6 (extremely poorly controlled).	Change from Baseline to Post-Intervention (8 weeks)
Secondary	Medication Adherence Report Scale (Adherence to Controller Medications for Asthma)	Self-report measure of adherence to controller medications with 10 items ranging from 1 (always) to 5 (never). Higher mean scores indicate greater adherence and a score > 4.5 is considered good adherence.	Change from Baseline to Post-Intervention (8 weeks)