NCT05387889: MMPH

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

Completed NA Results posted Last updated 8 November 2023

What this trial tests

NA trial testing Mindfulness Meditation for Pulmonary Hypertension (MMPH) in Hypertension, Pulmonary in 15 participants. Completed in 28 February 2023.

Timeline

17 June 2022

Primary endpoint
30 November 2022

28 February 2023

Quick facts

Lead sponsor	State University of New York at Buffalo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	17 June 2022
Primary completion	30 November 2022
Estimated completion	28 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness Meditation for Pulmonary Hypertension (MMPH)

Conditions studied

• Hypertension, Pulmonary — all drugs for Hypertension, Pulmonary →

Sponsor

State University of New York at Buffalo

Who can join

18 and older, any sex, with Hypertension, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Treatment Arm - Group 1	3.44444	± 2.403
Comparison Arm or Waited List Arm - Group 2	7.6666	± 2.011

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

Group	Value	95% CI
Treatment Arm - Group 1	19.0	± 11.068
Comparison Arm or Waited List Arm - Group 2	23.166	± 10.10

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

Group	Value	95% CI
Treatment Arm - Group 1	31.000	± 5.567
Comparison Arm or Waited List Arm - Group 2	27.00	± 4.242

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.