Clinical trial NCT05387889: Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension
Official title: Piloting an Evidence-based Mobile Mindfulness Practice to Support Self-management Among Underserved and Racial Minority Adults With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: pulmonary hypertension
racial minority
complementary health approach
integrative therapy
mindfulness-based intervention
symptom management
health-related quality of life
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-05-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: wait-listed control comparative groups
Primary purpose: TREATMENT

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?

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

Primary outcomes:
measure: Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8.
timeFrame: Baseline and at the end of the study intervention (Week #8)
Secondary outcomes:
measure: Change From Baseline in PH-related Quality of Life on the 50-point EmPHasis-10 Scales to Week #8.
timeFrame: Baseline and at the end of the study intervention (Week #8)
measure: Change From Baseline in Mindfulness Level on the 40-point Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) to Week #8.
timeFrame: Baseline and at the end of the study intervention (Week #8)
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: SUNY at Buffalo School of Nursing
state: New York
Study officials:
affiliation: State University of New York at Buffalo School of Nursing
name: Tania Von Visger
role: PRINCIPAL_INVESTIGATOR
References: