Trial Outcomes & Findings for Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension (NCT NCT05387889)
NCT ID: NCT05387889
Last Updated: 2023-11-08
Results Overview
Patient Health Questionnaire-9 is a validated, self-reported questionnaire assessing depressive symptoms over the past few weeks. Possible scores range from 0 to 27, indicating the levels of depression (0-4 = None or Minimal; 5-9 = Mild; 10-14 = Moderate; 15-19 = Moderately Severe; 20- 27 = Severe). Depressive symptoms comparison between Group 1 and Group 2 at the end of the intervention (Week #8). Depressive symptoms comparison at Baseline vs. Week #8 within Group 1 participants who received the intervention. Depressive symptoms comparison at Baseline vs. Week #8 within Group 2 participants who received the intervention.
COMPLETED
NA
15 participants
Baseline and at the end of the study intervention (Week #8)
2023-11-08
Participant Flow
Participant milestones
| Measure |
Treatment Arm - Group 1
This treatment Arm will receive MMPH intervention first, while the wait-listed group waits until this group is complete.
Then the wait-listed group will receive the same intervention after the first group completes it.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
Comparison Arm or Waited List Arm - Group 2
This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension
Baseline characteristics by cohort
| Measure |
Treatment Arm - Group 1
n=9 Participants
This treatment Arm will receive MMPH intervention first, while the wait-listed group waits until this group is complete.
Then the wait-listed group will receive the same intervention after the first group completes it.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
Comparison Arm or Waited List Arm - Group 2
n=6 Participants
This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
54.00 years
STANDARD_DEVIATION 13.92 • n=5 Participants
|
47.50 years
STANDARD_DEVIATION 7.82 • n=7 Participants
|
51.40 years
STANDARD_DEVIATION 11.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Depressive symptoms on the 27-point Patient Health Questionnaire-9 Scales
|
6.12500 units on a scale
STANDARD_DEVIATION 5.30330 • n=5 Participants
|
9.80000 units on a scale
STANDARD_DEVIATION 8.55570 • n=7 Participants
|
7.9625 units on a scale
STANDARD_DEVIATION 6.9295 • n=5 Participants
|
|
PH-related Quality of Life on the 50-point EmPHasis-10 Scale
|
22.7500 units on a scale
STANDARD_DEVIATION 11.5357 • n=5 Participants
|
25.6000 units on a scale
STANDARD_DEVIATION 9.7877 • n=7 Participants
|
24.175 units on a scale
STANDARD_DEVIATION 10.6617 • n=5 Participants
|
|
Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale
|
28.2500 units on a scale
STANDARD_DEVIATION 4.89168 • n=5 Participants
|
25.8000 units on a scale
STANDARD_DEVIATION 2.28035 • n=7 Participants
|
27.025 units on a scale
STANDARD_DEVIATION 3.586 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at the end of the study intervention (Week #8)Population: For this analysis, 9 patients were analyzed for Arm 1, and 6 patients were analyzed for Arm 2.
Patient Health Questionnaire-9 is a validated, self-reported questionnaire assessing depressive symptoms over the past few weeks. Possible scores range from 0 to 27, indicating the levels of depression (0-4 = None or Minimal; 5-9 = Mild; 10-14 = Moderate; 15-19 = Moderately Severe; 20- 27 = Severe). Depressive symptoms comparison between Group 1 and Group 2 at the end of the intervention (Week #8). Depressive symptoms comparison at Baseline vs. Week #8 within Group 1 participants who received the intervention. Depressive symptoms comparison at Baseline vs. Week #8 within Group 2 participants who received the intervention.
Outcome measures
| Measure |
Treatment Arm - Group 1
n=9 Participants
This treatment Arm will receive MMPH intervention first, while the wait-listed group waits until this group is complete.
Then the wait-listed group will receive the same intervention after the first group completes it.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
Comparison Arm or Waited List Arm - Group 2
n=6 Participants
This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
|---|---|---|
|
Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8.
|
3.44444 score on scale
Standard Deviation 2.403
|
7.6666 score on scale
Standard Deviation 2.011
|
SECONDARY outcome
Timeframe: Baseline and at the end of the study intervention (Week #8)Population: For this analysis, 9 patients were analyzed for Arm 1, and 6 patients were analyzed for Arm 2.
EmPHasis-10 (full name, not an abbreviation) is a validated, self-reported standardized questionnaire assessing PH-related quality of life over the past few weeks. The EmPHasis-10 questionnaire is used during clinical assessments to determine how pulmonary hypertension affects someone's life. Possible scores range from 0 to 50, (0 = high quality of life; 50 = poor quality of life) Change = (Week #8 Score - Baseline Score) Health-related quality of life comparison between Group 1 and Group 2 at the end of the intervention (Week #8). Health-related quality of life comparison at Baseline vs. Week #8 within Group 1 participants who received the intervention. Health-related quality of life comparison at Baseline vs. Week #8 within Group 2 participants who received the intervention.
Outcome measures
| Measure |
Treatment Arm - Group 1
n=9 Participants
This treatment Arm will receive MMPH intervention first, while the wait-listed group waits until this group is complete.
Then the wait-listed group will receive the same intervention after the first group completes it.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
Comparison Arm or Waited List Arm - Group 2
n=6 Participants
This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
|---|---|---|
|
Change From Baseline in PH-related Quality of Life on the 50-point EmPHasis-10 Scales to Week #8.
|
19.0 score on scale
Standard Deviation 11.068
|
23.166 score on scale
Standard Deviation 10.10
|
SECONDARY outcome
Timeframe: Baseline and at the end of the study intervention (Week #8)Population: For this analysis, 9 patients were analyzed for Arm 1, and 6 patients were analyzed for Arm 2.
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a validated, self-reported questionnaire assessing the degree of an individual's Mindfulness Level over the past few weeks. Possible scores range from 10 to 40 (10 = low level of mindfulness; 40 = high level of mindfulness) Mindfulness level comparison between Group 1 and Group 2 at the end of the intervention (Week #8). Mindfulness level comparison at Baseline vs. Week #8 within Group 1 participants who received the intervention. Mindfulness level comparison at Baseline vs. Week #8 within Group 2 participants who received the intervention.
Outcome measures
| Measure |
Treatment Arm - Group 1
n=9 Participants
This treatment Arm will receive MMPH intervention first, while the wait-listed group waits until this group is complete.
Then the wait-listed group will receive the same intervention after the first group completes it.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
Comparison Arm or Waited List Arm - Group 2
n=6 Participants
This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.
Mindfulness Meditation for Pulmonary Hypertension (MMPH): Eight weeks of Mindfulness Meditation practice for patients with Pulmonary Hypertension condition. The content will focus on how to apply Mindfulness concepts to the everyday management of symptoms and stress.
|
|---|---|---|
|
Change From Baseline in Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) to Week #8.
|
31.000 score on scale
Standard Deviation 5.567
|
27.00 score on scale
Standard Deviation 4.242
|
Adverse Events
Treatment Arm
Comparison Arm or Waited List Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tania Von Visger
State University of New York at Buffalo School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place