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

NCT05387889 | Completed Results DMC

• 2 other identifiers: 12345UL1TR001412
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension, Pulmonary

Keywords

pulmonary hypertension; racial minority; complementary health approach; integrative therapy; mindfulness-based intervention; symptom management; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to 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.

  Baseline and at the end of the study intervention (Week #8)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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.

Behavioral: Mindfulness Meditation for Pulmonary Hypertension (MMPH)

Comparison Arm or Waited List Arm

ACTIVE COMPARATOR

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

Behavioral: Mindfulness Meditation for Pulmonary Hypertension (MMPH)

Interventions

Mindfulness Meditation for Pulmonary Hypertension (MMPH) 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.

Also known as: MMPH intervention

Comparison Arm or Waited List Arm; Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

SUNY at Buffalo School of Nursing

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Tania Von Visger
• Organization: State University of New York at Buffalo School of Nursing

Taniavon@buffalo.edu

7168292201

Study Officials

• Tania Von Visger

  State University of New York at Buffalo School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All participants will receive intervention according to the wait-listed control comparative groups. Therefore, masking is not applicable in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: wait-listed control comparative groups

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: May 24, 2022
• Study Start: June 17, 2022
• Primary Completion: November 30, 2022
• Study Completion: February 28, 2023
• Last Updated: November 8, 2023
• Results First Posted: November 8, 2023

Record last verified: 2023-11

Locations

US (1)