Trial Outcomes & Findings for LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction (NCT NCT01583296)
NCT ID: NCT01583296
Last Updated: 2022-10-05
Results Overview
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.
COMPLETED
NA
53 participants
Baseline, Post-Treatment (end of week 8)
2022-10-05
Participant Flow
Participant milestones
| Measure |
CBT and HRVB
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
CBT and HRVB: cognitive behavioral therapy and heart rate variability biofeedback
|
Music Relaxation Therapy (MRT)
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Music Relaxation Therapy (MRT): music relaxation therapy and breathing at resting respiration rate
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
CBT and HRVB
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
CBT and HRVB: cognitive behavioral therapy and heart rate variability biofeedback
|
Music Relaxation Therapy (MRT)
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
Music Relaxation Therapy (MRT): music relaxation therapy and breathing at resting respiration rate
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
10
|
Baseline Characteristics
LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction
Baseline characteristics by cohort
| Measure |
CBT and HRVB
n=24 Participants
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
|
Music Relaxation Therapy (MRT)
n=24 Participants
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
42.6 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
43.2 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States · Continental US-Born
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
United States · Non-Continental US-Born
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Household Income
>$16000
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Household Income
< $16000
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Education
At least some college
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Education
High School
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Education
Less than high school
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Marital Status
Married
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Marital Status
Never married
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Marital Status
Separated/Divorced/Widowed
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Employment Status
Employed or Student
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Employment Status
Unemployed
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Health Insurance
Medicaid or Medicare
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Health Insurance
Other
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Cigarette Smoking History
Current Smoker
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Cigarette Smoking History
Ex-Smoker
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Cigarette Smoking History
Never Smoked
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Asthma Severity
Intermittent/Mild Persistent
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Asthma Severity
Moderate Persistent
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Asthma Severity
Severe Persistent
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Language
English
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Language
Spanish
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-Treatment (end of week 8)Population: While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, outcome measures were analyzed for the 48 participants (24 in each arm) that completed their baseline sessions.
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.
Outcome measures
| Measure |
CBT and HRVB
n=24 Participants
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
|
Music Relaxation Therapy (MRT)
n=24 Participants
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
|
|---|---|---|
|
Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale
Baseline
|
2.17 score on a scale
Standard Error 0.16
|
2.40 score on a scale
Standard Error 0.17
|
|
Change in Severity of Panic Disorder as Measured by the Panic Disorder Severity Scale
Post-Treatment
|
1.64 score on a scale
Standard Error 0.18
|
1.52 score on a scale
Standard Error 0.19
|
PRIMARY outcome
Timeframe: Change from Baseline to Post-Intervention (8 weeks)Population: While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, outcome measures were analyzed for the 48 participants (24 in each arm) that completed their baseline sessions.
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).
Outcome measures
| Measure |
CBT and HRVB
n=24 Participants
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
|
Music Relaxation Therapy (MRT)
n=24 Participants
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
|
|---|---|---|
|
Asthma Control Based on Rescue Medication Use
Baseline
|
28.99 % good asthma control
Standard Error 10.69
|
23.24 % good asthma control
Standard Error 9.69
|
|
Asthma Control Based on Rescue Medication Use
Post-Treatment
|
55.42 % good asthma control
Standard Error 12.83
|
51.48 % good asthma control
Standard Error 13.36
|
PRIMARY outcome
Timeframe: Change from Baseline to Post-Intervention (8 weeks)Population: While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, outcome measures were analyzed for the 48 participants (24 in each arm) that completed their baseline sessions.
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.
Outcome measures
| Measure |
CBT and HRVB
n=24 Participants
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
|
Music Relaxation Therapy (MRT)
n=24 Participants
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
|
|---|---|---|
|
Clinical Global Impression Scale (CGI)
Responders
|
7 Participants
|
5 Participants
|
|
Clinical Global Impression Scale (CGI)
Non-Responders
|
17 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Post-Intervention (8 weeks)Population: While 27 participants were allocated to the CBPT intervention, 3 dropped out before the baseline session. Similarly, 26 participants were allocated to the MRT intervention but 2 dropped out before the baseline session. Accordingly, outcome measures were analyzed for the 48 participants (24 in each arm) that completed their baseline sessions.
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).
Outcome measures
| Measure |
CBT and HRVB
n=24 Participants
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
|
Music Relaxation Therapy (MRT)
n=24 Participants
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ)
Baseline
|
0.85 natural log transformed score on a scale
Standard Error 0.14
|
0.85 natural log transformed score on a scale
Standard Error 0.15
|
|
Asthma Control Questionnaire (ACQ)
Post-Treatment
|
0.22 natural log transformed score on a scale
Standard Error 0.17
|
0.46 natural log transformed score on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Change from Baseline to Post-Intervention (8 weeks)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.
Outcome measures
| Measure |
CBT and HRVB
n=24 Participants
Cognitive Behavioral Therapy (CBT) and Heart Rate Variability Biofeedback (HRVB)
|
Music Relaxation Therapy (MRT)
n=24 Participants
Music Relaxation Therapy (MRT): music relaxation and breathing at resting respiration rate
|
|---|---|---|
|
Medication Adherence Report Scale (Adherence to Controller Medications for Asthma)
Baseline
|
3.51 score on a scale
Standard Error 0.17
|
4.38 score on a scale
Standard Error 0.18
|
|
Medication Adherence Report Scale (Adherence to Controller Medications for Asthma)
Post-Treatment
|
4.15 score on a scale
Standard Error 0.17
|
4.40 score on a scale
Standard Error 0.20
|
Adverse Events
CBT and HRVB
Music Relaxation Therapy (MRT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jonathan M. Feldman
Ferkauf Graduate School of Psychology, Yeshiva University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place