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

Not Applicable

Completed

Conditions: Hypertension, Pulmonary

Interventions: Behavioral: Mindfulness Meditation for Pulmonary Hypertension (MMPH)

Registration Number: NCT05387889

Lead Sponsor: State University of New York at Buffalo

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?

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison Arm or Waited List Arm	Mindfulness Meditation for Pulmonary Hypertension (MMPH)	This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.
Treatment Arm	Mindfulness Meditation for Pulmonary Hypertension (MMPH)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.