Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04441086
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2020-06-11
Brief Title:
Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2023-10
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:
eMotion
Brief Summary:
The purpose of this study is to evaluate early preliminary efficacy of the eMotion intervention in US adults who have experienced a first cardiac event and participating in phase II cardiac rehabilitation
This study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables Investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms threat and stress cognition and motivation symptoms depression anxiety pain sleep and fatigue and health related quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event
This study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables Investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms threat and stress cognition and motivation symptoms depression anxiety pain sleep and fatigue and health related quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event
Detailed Description:
Aim 1 Evaluate early preliminary efficacy of the eMotion intervention
Research hypothesis 1 Compared with adults randomized to active healthy living attention control and usual care control groups adults randomized to eMotion will have greater improvement in these outcomes over time
11 Improved minutes of moderate to vigorous physical activity 12 Symptom improvement depression anxiety pain sleep and fatigue 13 Health related quality of life
Aim 2 Evaluate the cognitive processes as intervention response variables
Research hypothesis 2 Compared with adults randomized to active healthy living attention control and usual care control groups adults randomized to eMotion will have
21 Improved emotion regulation efficiency and strategy use 22 Decreased perceived cardiac threat and general stress 23 Improved cognition and motivation
Aim 3 Exploratory Examine the relationships between emotion regulation and other cognitive processes and symptoms threat and stress cognition and motivation and symptoms depression anxiety pain sleep and fatigue among adults enrolled in cardiac rehabilitation after a first major cardiac event
Research hypothesis 1 Compared with adults randomized to active healthy living attention control and usual care control groups adults randomized to eMotion will have greater improvement in these outcomes over time
11 Improved minutes of moderate to vigorous physical activity 12 Symptom improvement depression anxiety pain sleep and fatigue 13 Health related quality of life
Aim 2 Evaluate the cognitive processes as intervention response variables
Research hypothesis 2 Compared with adults randomized to active healthy living attention control and usual care control groups adults randomized to eMotion will have
21 Improved emotion regulation efficiency and strategy use 22 Decreased perceived cardiac threat and general stress 23 Improved cognition and motivation
Aim 3 Exploratory Examine the relationships between emotion regulation and other cognitive processes and symptoms threat and stress cognition and motivation and symptoms depression anxiety pain sleep and fatigue among adults enrolled in cardiac rehabilitation after a first major cardiac event
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