Status:
RECRUITING
Mindfulness App Training for Cardiovascular Health
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Mindfulness
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
This study will investigate the feasibility and effects of a smartphone-based mindfulness training program vs. usual care in a sample of stressed midlife and older adults at risk for cardiovascular di...
Detailed Description
This study is aimed at assessing the feasibility and effects of a smartphone-based mindfulness training program vs. usual care. The objective is to determine the program's effectiveness in reducing st...
Eligibility Criteria
Inclusion
- Age 45 years or older
- Fluent in English and proficient in reading English
- Living in the Pittsburgh area for the next 5 months and available for study visits and activities during this period
- High perceived stress (greater than or equal to 14 on the 10-item Perceived Stress Scale)
- Diagnosed with hypertension by medical provider and, if medicated, blood pressure below 150/100, or if unmedicated, clinic blood pressure reading greater than or equal to 125/75 and less than 150/100
- Moderate-to-high cardiovascular disease risk, as indicated by hypertension and at least 1 of the following:
- Diagnosed with diabetes by medical provider
- Diagnosed with high cholesterol by medical provider
- Current smoker by self-report (smoking or vaping every day or nearly every day)
- Body Mass Index ≥30
- Android or iOS smartphone that meets study requirements
- Participant otherwise able to meet study requirements
Exclusion
- Clinical or symptomatic atherosclerotic disease, including ischemic heart disease, heart failure, angina, stroke, or atrial fibrillation
- Two or more "night shift" episodes in the past month
- Pregnancy
- Typical alcohol consumption ≥15 drinks per week
- Marijuana or hashish use \>9 of the past 30 days
- Use of other controlled substances (e.g., cocaine, crack, heroin, meth, ecstasy) in the past 30 days
- Current moderate-to-severe depressive symptoms (score ≥15 on PHQ-9)
- Suicidal ideation (PHQ-9 item 9 score \>0)
- Positive PTSD screen (traumatic event(s) endorsed and total score ≥3 on Primary Care PTSD screen for DSM-5)
- Positive Bipolar Disorder screen (≥7 yes responses to item 1, yes to item 2, and moderate or serious on item 3 of Mood Disorder Questionnaire)
- Positive screen for psychosis (≥1 on Two-Item Screen for Early Psychosis)
- Regular systematic mind-body practice (e.g., yoga or meditation \>2 times/week)
- Current participation in another clinical trial or in a study that uses smartphone software
Key Trial Info
Start Date :
February 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06152185
Start Date
February 6 2024
End Date
April 30 2026
Last Update
July 18 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213