Mindfulness App Training for Cardiovascular Health

Launched by UNIVERSITY OF PITTSBURGH · Nov 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a mindfulness training program delivered through a smartphone app can help improve heart health in stressed adults who are at risk for cardiovascular disease. Participants will be either part of the mindfulness training group, which involves listening to audio lessons and practicing mindfulness three times a day for four weeks, or they will continue with their usual routines. The study is looking for adults aged 45 and older who live in the Pittsburgh area, have high perceived stress levels, and have been diagnosed with hypertension, among other health concerns.

If you decide to participate, you can expect to attend seven visits to the lab over the course of the study. During these visits, you'll receive training and complete assessments related to your daily stress and health. Researchers will collect information about how you feel and your body's response to stress before, immediately after, and three months after the mindfulness training. They will also use data from your smartphone and wearable devices to understand your daily stress levels better. This study aims to find out if mindfulness training can be a helpful tool for managing stress and improving heart health in adults at risk for cardiovascular issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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