LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction (LUCHAR)
Primary Purpose
Asthma, Panic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Relaxation Therapy (MRT)
CBT and HRVB
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
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
Sites / Locations
- Jacobi Medical Center/North Central Bronx Hospital (NBHN)
- Montefiore Medical Center: Moses Division/Weiler Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT and HRVB
Music Relaxation Therapy (MRT)
Arm Description
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Outcomes
Primary Outcome Measures
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.
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).
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT01583296
First Posted
April 19, 2012
Last Updated
September 28, 2022
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01583296
Brief Title
LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction
Acronym
LUCHAR
Official Title
Adaptation of a Behavioral Treatment for Latinos With Panic Disorder/Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT and HRVB
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
Arm Title
Music Relaxation Therapy (MRT)
Arm Type
Active Comparator
Arm Description
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Intervention Type
Behavioral
Intervention Name(s)
Music Relaxation Therapy (MRT)
Intervention Description
music relaxation therapy and breathing at resting respiration rate
Intervention Type
Behavioral
Intervention Name(s)
CBT and HRVB
Intervention Description
cognitive behavioral therapy and heart rate variability biofeedback
Primary Outcome Measure Information:
Title
Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale
Description
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.
Time Frame
Baseline, Post-Treatment (end of week 8)
Title
Asthma Control Based on Rescue Medication Use
Description
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).
Time Frame
Change from Baseline to Post-Intervention (8 weeks)
Title
Clinical Global Impression Scale (CGI)
Description
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.
Time Frame
Change from Baseline to Post-Intervention (8 weeks)
Secondary Outcome Measure Information:
Title
Asthma Control Questionnaire (ACQ)
Description
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).
Time Frame
Change from Baseline to Post-Intervention (8 weeks)
Title
Medication Adherence Report Scale (Adherence to Controller Medications for Asthma)
Description
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.
Time Frame
Change from Baseline to Post-Intervention (8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Feldman, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center/North Central Bronx Hospital (NBHN)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Medical Center: Moses Division/Weiler Division
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Learn more about this trial
LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction
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