Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152185
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-21
Brief Title:
Mindfulness App Training for Cardiovascular Health
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Mindfulness App Training for Cardiovascular Health
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATCH
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 disease 150 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
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 programs effectiveness in reducing stress levels and cardiovascular responses to stress in the daily lives of participants with a specific focus on individuals at risk of cardiovascular disease Participants will be aged 45 or above and have risk factors for cardiovascular disease
Participants will be randomly assigned to either receive a smartphone-based mindfulness training program or continue their regular daily routines The study consists of seven laboratory visits that include assessments and training for completing at-home study activities and using monitoring devices These devices will track activity levels heart rate and various stress indicators during the study at three separate weeklong periods
A mobile blood pressure device will take hourly blood pressure readings during three monitoring days at pre-intervention post-intervention and three-month follow-up On these days participants will complete brief surveys on their smartphones at each reading and at the beginning and end of each day about their mood behaviors and social interactions Participants will also wear Fitbit activity monitors and a sensor application will be installed on participants smartphones to continuously collect data on movement heart rate location screen status and other parameters Together this data will be used to gain insights into daily stress indicators
Participants assigned to the mindfulness training group will engage in daily 20-minute audio recordings and practice assignments at home over a one-month period They will also be asked to answer questions about their daily stressors and the effectiveness of the training program both at the beginning and end of each day The study team will periodically contact them by phone to address any questions or concerns during this month Participants assigned to the usual care control group will receive resources for stress management but will not participate in a structured intervention or be required to respond to specific questions over the one-month period
After the intervention period all participants will complete a second week of daily life monitoring and a third week of monitoring three months later They will also complete a laboratory cardiovascular reactivity task at pre-intervention and post-intervention
Participants will be randomly assigned to either receive a smartphone-based mindfulness training program or continue their regular daily routines The study consists of seven laboratory visits that include assessments and training for completing at-home study activities and using monitoring devices These devices will track activity levels heart rate and various stress indicators during the study at three separate weeklong periods
A mobile blood pressure device will take hourly blood pressure readings during three monitoring days at pre-intervention post-intervention and three-month follow-up On these days participants will complete brief surveys on their smartphones at each reading and at the beginning and end of each day about their mood behaviors and social interactions Participants will also wear Fitbit activity monitors and a sensor application will be installed on participants smartphones to continuously collect data on movement heart rate location screen status and other parameters Together this data will be used to gain insights into daily stress indicators
Participants assigned to the mindfulness training group will engage in daily 20-minute audio recordings and practice assignments at home over a one-month period They will also be asked to answer questions about their daily stressors and the effectiveness of the training program both at the beginning and end of each day The study team will periodically contact them by phone to address any questions or concerns during this month Participants assigned to the usual care control group will receive resources for stress management but will not participate in a structured intervention or be required to respond to specific questions over the one-month period
After the intervention period all participants will complete a second week of daily life monitoring and a third week of monitoring three months later They will also complete a laboratory cardiovascular reactivity task at pre-intervention and post-intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34HL163245 | NIH | None | httpsreporternihgovquickSearchR34HL163245 |