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

NCT ID: NCT05387889

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2023-02-28

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?

Conditions

Hypertension, Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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.

Group Type: EXPERIMENTAL

Mindfulness Meditation for Pulmonary Hypertension (MMPH)

Intervention Type: BEHAVIORAL

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.

Comparison Arm or Waited List Arm

This active comparator Arm will not receive MMPH intervention at the beginning. They will receive the intervention once the Treatment Group completed the intervention.

Group Type: ACTIVE_COMPARATOR

Mindfulness Meditation for Pulmonary Hypertension (MMPH)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MMPH intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Tania T Von Visger

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tania Von Visger

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo School of Nursing

Locations

SUNY at Buffalo School of Nursing

Buffalo, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UL1TR001412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

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Identifier Type: -

Identifier Source: org_study_id