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

(MMPH Trial)

Overseen By Tania Von Visger, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Pregnancy, Psychiatric conditions, Mind-body practices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness practices, so it's likely you can continue your medications, but please confirm with the trial organizers.

What data supports the effectiveness of the treatment Mindfulness Meditation for Pulmonary Hypertension (MMPH)?

Research suggests that mindfulness-based stress reduction (MBSR), a similar treatment, may help reduce the psychological burden in people with pulmonary arterial hypertension (PAH). Additionally, self-compassion, which can be enhanced through mindfulness practices, is linked to better mental health and quality of life in individuals with PH. ^{1 2 3 4 5}

Is Mindfulness Meditation for Pulmonary Hypertension (MMPH) safe for humans?

The research on mindfulness-based stress reduction (MBSR), which is similar to MMPH, does not report any safety concerns for humans, suggesting it is generally safe. ^{2 4 6 7 8}

How does the treatment Mindfulness Meditation for Pulmonary Hypertension (MMPH) differ from other treatments for pulmonary hypertension?

Mindfulness Meditation for Pulmonary Hypertension (MMPH) is unique because it focuses on reducing the psychological burden of the condition through mindfulness-based stress reduction (MBSR), which has not been traditionally applied to pulmonary hypertension. Unlike standard medical treatments that target the physical symptoms, MMPH aims to improve mental well-being and quality of life by teaching patients to manage stress and anxiety. ^{1 2 4 5 6}

What is the purpose of this trial?

This trial tests a mindfulness meditation program delivered via Zoom and a mobile app for adults in Western New York. The program aims to reduce stress and improve well-being through meditation, gentle movements, and restorative poses.

Research Team

Tania Von Visger

Principal Investigator

State University of New York at Buffalo School of Nursing

Eligibility Criteria

Inclusion Criteria

PH confirmed by standard guidelines

Able to ambulate independently

English-speaking

Exclusion Criteria

Known pregnancy

Have psychiatric conditions requiring hospitalization within the last year

You currently practice mind-body techniques.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants engage in an 8-week Mindfulness Meditation Program with two Zoom sessions and daily mobile app practice

8 weeks

2 visits (virtual)

Follow-up

Participants are monitored for changes in depressive symptoms, quality of life, and mindfulness levels

4 weeks

Treatment Details

Interventions

• Mindfulness Meditation for Pulmonary Hypertension (MMPH)

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

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 II: Comparison Arm or Waited List Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

In a study of 108 patients with pulmonary arterial hypertension (PAH), the use of actigraphy to measure daily life physical activity (DLPA) showed that selexipag did not lead to significant improvements in physical activity levels compared to placebo over 24 weeks.

Despite high compliance with the accelerometer, changes in daily physical activity were small and variable, indicating that selexipag may not have a meaningful impact on improving quality of life through increased physical activity in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Howard, LS., Rosenkranz, S., Frantz, RP., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Progressive muscle relaxation improves anxiety and depression of pulmonary arterial hypertension patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Can self-compassion help us better understand the impact of pulmonary hypertension on those with the condition and their carers? A cross-sectional analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A pilot randomised controlled trial investigating a mindfulness-based stress reduction (MBSR) intervention in individuals with pulmonary arterial hypertension (PAH): the PATHWAYS study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Metacognitions in Patients With Frequent Mental Disorders After Diagnosis of Pulmonary Arterial Hypertension. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Anxiety, Depression and Quality of Life in Pulmonary Hypertension: A Comparison of Incident and Prevalent Cases. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prevalence of Anxiety and Depression in Pulmonary Hypertension and Changes during Therapy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life and disease progression in pulmonary arterial hypertension patients: a 3-year study. [2022]