Skip to content

Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension

Piloting an Evidence-based Mobile Mindfulness Practice to Support Self-management Among Underserved and Racial Minority Adults With Pulmonary Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05387889
Acronym
MMPH
Enrollment
15
Registered
2022-05-24
Start date
2022-06-17
Completion date
2023-02-28
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

Keywords

pulmonary hypertension, racial minority, complementary health approach, integrative therapy, mindfulness-based intervention, symptom management, health-related quality of life

Brief summary

The MMPH program will include two Zoom-delivered sessions (Weeks #1 & #4), six video-recorded sessions (Weeks #2, #3, #5, #6, #7, #8), and daily mindfulness meditation practice using a mobile APP during an eight-week study period. Similar to the Urban Zen Integrative Therapy intervention, each MMPH session will include Gentle Body Movement (GBM,10-min), Restorative Pose (Pose,10-min), and Body Awareness Meditation (BAM, 20-min). Self-guided audio-video modules of various durations will be available according to participants' preference and level of comfort (5, 10, 20 minutes). The mobile-APP content will reinforce Zoom content such as mindful breathing, GBM of upper extremities, GBM of lower extremities, Pose sitting, Pose lying, and BAM practices. The MMPH content will be tailored to health management needs specific to PH with cultural consideration of mindfulness-related concepts (stress, responding to stress, resiliency).

Detailed description

Study design: This study will engage community-dwelling URM adults with PH living in Western New York. We will use a two-group comparative study design where waitlisted participants will serve as controls. Considering a 20% attrition rate in a behavioral health intervention study, we aim to enroll a total of 20, with at least 16 participants to address study aims (8-10 in each group). As a pilot study, power analysis is not necessary. Statistical analysis will include descriptive statistics, mixed-effect modeling for repeated measures, and within-group and between-groups comparisons using t-tests or Wilcoxon signed-rank test as appropriate and Cohen's d effect size calculation. Multi-time data collection will be done via daily mobile-APP use. Setting/ Sample: We will recruit PH patients from two PH clinics managed by UB PH Specialists, a local PH support group, and through the CTSI community outreach programs. Recruitment materials will be disseminated to PH physicians, PH support group leaders, and community leaders, inviting patients to participate in the study. Interested patients will contact research staff by phone or email and will be guided to complete the eligibility questionnaire online using REDCAP. If eligible and interested, participants will meet with research staff to provide verbal consent via Zoom after reviewing the Consent Form content. During the meeting, the research staff will review the purpose of the study, study procedures, and risks and benefits. After providing verbal consent, participants will complete the Demographic and Clinical Characteristic questionnaire online. The initial 10 participants enrolled will be scheduled to begin the program, including mutually agreeable Zoom #1 and Zoom #2 appointments. They will also be provided with a de-identified user ID and password to register and download the MMPH APP to his/her personal phone (Table 1- Study Procedure). Intervention: MMPH program will include two Zoom-delivered sessions (Weeks #1 & #4) and the daily practice of Mindfulness meditation using a mobile-APP for an eight-week study period. Similar to the UZIT intervention, each MMPH session will include Gentle Body Movement (GBM,10-min), Restorative Pose (Pose,10-min), and Body Awareness Meditation (BAM, 20-min). Self-guided audio-video modules of various durations will be available according to participants' preference and level of comfort (5, 10, 20 minutes). The mobile-APP content will reinforce Zoom content such as mindful breathing, GBM of upper extremities, GBM of lower extremities, Pose sitting, Pose lying, and BAM practices. The MMPH content will be tailored to health management needs specific to PH with cultural consideration of mindfulness-related concepts (stress, responding to stress, resiliency). Individual Zoom Interviews: will take place at a convenient time during the last week of the study. The primary focus of this interview is to collect qualitative data about their participation experience in the MMPH program. Standard qualitative thematic analysis procedures will be employed. The following open-ended questions will guide the discussion: 1) What are your general impressions of the program?; 2) How does this program affect you in the management of your PH-related symptoms?; 3) What do you like & do not like about the program?; and 4) What improvements would you recommend?

Interventions

BEHAVIORALMindfulness 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.

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

All participants will receive intervention according to the wait-listed control comparative groups. Therefore, masking is not applicable in this study.

Intervention model description

wait-listed control comparative groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults (\>18 years) * PH confirmed by standard guidelines * Self-identified as URM person * Willingness to participate in the mindfulness practice program for the duration of the study period * Able to ambulate independently * English-speaking * Have access to a mobile phone

Exclusion criteria

* Known pregnancy * Have psychiatric conditions requiring hospitalization within the last year * Current practitioner of mind-body practices * Current user of Mindfulness APP * Deaf or hard of hearing

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8.Baseline and at the end of the study intervention (Week #8)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.

Secondary

MeasureTime frameDescription
Change From Baseline in PH-related Quality of Life on the 50-point EmPHasis-10 Scales to Week #8.Baseline and at the end of the study intervention (Week #8)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.
Change From Baseline in Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) to Week #8.Baseline and at the end of the study intervention (Week #8)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
9
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.
6
Total15

Baseline characteristics

CharacteristicTreatment Arm - Group 1Comparison Arm or Waited List Arm - Group 2Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants0 Participants3 Participants
Age, Categorical
Between 18 and 65 years
6 Participants6 Participants12 Participants
Age, Continuous54.00 years
STANDARD_DEVIATION 13.92
47.50 years
STANDARD_DEVIATION 7.82
51.40 years
STANDARD_DEVIATION 11.97
Depressive symptoms on the 27-point Patient Health Questionnaire-9 Scales6.12500 units on a scale
STANDARD_DEVIATION 5.3033
9.80000 units on a scale
STANDARD_DEVIATION 8.5557
7.9625 units on a scale
STANDARD_DEVIATION 6.9295
Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale28.2500 units on a scale
STANDARD_DEVIATION 4.89168
25.8000 units on a scale
STANDARD_DEVIATION 2.28035
27.025 units on a scale
STANDARD_DEVIATION 3.586
PH-related Quality of Life on the 50-point EmPHasis-10 Scale22.7500 units on a scale
STANDARD_DEVIATION 11.5357
25.6000 units on a scale
STANDARD_DEVIATION 9.7877
24.175 units on a scale
STANDARD_DEVIATION 10.6617
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants5 Participants13 Participants
Region of Enrollment
United States
9 Participants6 Participants15 Participants
Sex: Female, Male
Female
8 Participants6 Participants14 Participants
Sex: Female, Male
Male
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 6
other
Total, other adverse events
0 / 90 / 6
serious
Total, serious adverse events
0 / 90 / 6

Outcome results

Primary

Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8.

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Treatment Arm - Group 1Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8.3.44444 score on scaleStandard Deviation 2.403
Comparison Arm or Waited List Arm - Group 2Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8.7.6666 score on scaleStandard Deviation 2.011
p-value: <0.054ANCOVA
Secondary

Change From Baseline in Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) to Week #8.

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Treatment Arm - Group 1Change From Baseline in Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) to Week #8.31.000 score on scaleStandard Deviation 5.567
Comparison Arm or Waited List Arm - Group 2Change From Baseline in Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) to Week #8.27.00 score on scaleStandard Deviation 4.242
p-value: <0.07ANCOVA
Secondary

Change From Baseline in PH-related Quality of Life on the 50-point EmPHasis-10 Scales to Week #8.

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Treatment Arm - Group 1Change From Baseline in PH-related Quality of Life on the 50-point EmPHasis-10 Scales to Week #8.19.0 score on scaleStandard Deviation 11.068
Comparison Arm or Waited List Arm - Group 2Change From Baseline in PH-related Quality of Life on the 50-point EmPHasis-10 Scales to Week #8.23.166 score on scaleStandard Deviation 10.1
p-value: <0.25ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026