N/A
Completed N=15
Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension
Hypertension, Pulmonary
Source: ClinicalTrials.gov NCT05387889 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8. — 3.44444; 7.6666 score on scale — p=< 0.054
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8. |
3.44444; 7.6666 | < 0.054 |
| SECONDARY Change From Baseline in PH-related Quality of Life on the 50-point EmPHasis-10 Scales to Week #8. |
19.0; 23.166 | < 0.25 |
| SECONDARY Change From Baseline in Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) to Week #8. |
31.000; 27.00 | < 0.07 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05387889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.