RECRUITING

Mindfulness App Training for Cardiovascular Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 disease. 105 participants will be randomly assigned to complete a four-week mindfulness training intervention, which involves 28 audio-guided lessons and practice prompts delivered 3x daily, or to continue with their regular routines. Data will be collected at baseline, post-intervention, and three-month follow-up. The study will involve seven laboratory visits, which will include assessments and training on daily life monitoring and intervention procedures. Data assessing subjective and physiological stress reactivity in daily life will be collected for 3 days at pre-intervention, post-intervention, and 3-month follow-up. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop models that predict daily life stress. Data will be used to evaluate feasibility of the intervention and assessments in a sample at risk for cardiovascular disease and to test effects of mindfulness training on subjective and physiological stress reactivity.

Official Title

Mindfulness App Training for Cardiovascular Health

Quick Facts

Study Start:2024-02-06
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06152185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 45 years or older
  2. * Fluent in English and proficient in reading English
  3. * Living in the Pittsburgh area for the next 5 months and available for study visits and activities during this period
  4. * High perceived stress (greater than or equal to 14 on the 10-item Perceived Stress Scale)
  5. * 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
  6. * Moderate-to-high cardiovascular disease risk, as indicated by hypertension and at least 1 of the following:
  7. * Diagnosed with diabetes by medical provider
  8. * Diagnosed with high cholesterol by medical provider
  9. * Current smoker by self-report (smoking or vaping every day or nearly every day)
  10. * Body Mass Index ≥30
  11. * Android or iOS smartphone that meets study requirements
  12. * Participant otherwise able to meet study requirements
  1. * Clinical or symptomatic atherosclerotic disease, including ischemic heart disease, heart failure, angina, stroke, or atrial fibrillation
  2. * Two or more "night shift" episodes in the past month
  3. * Pregnancy
  4. * Typical alcohol consumption ≥15 drinks per week
  5. * Marijuana or hashish use \>9 of the past 30 days
  6. * Use of other controlled substances (e.g., cocaine, crack, heroin, meth, ecstasy) in the past 30 days
  7. * Current moderate-to-severe depressive symptoms (score ≥15 on PHQ-9)
  8. * Suicidal ideation (PHQ-9 item 9 score \>0)
  9. * Positive PTSD screen (traumatic event(s) endorsed and total score ≥3 on Primary Care PTSD screen for DSM-5)
  10. * 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)
  11. * Positive screen for psychosis (≥1 on Two-Item Screen for Early Psychosis)
  12. * Regular systematic mind-body practice (e.g., yoga or meditation \>2 times/week)
  13. * Current participation in another clinical trial or in a study that uses smartphone software

Contacts and Locations

Study Contact

Thomas W Kamarck, PhD
CONTACT
412-624-2080
tkam@pitt.edu
Emily K Lindsay, PhD
CONTACT
412-648-4515
emily.lindsay@pitt.edu

Principal Investigator

Thomas W Kamarck, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Emily K Lindsay, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Thomas W Kamarck, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh
  • Emily K Lindsay, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-06
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-02-06
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Mindfulness
  • Cardiovascular Disease
  • Stress

Additional Relevant MeSH Terms

  • Cardiovascular Diseases
  • Mindfulness