Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction (eMotion)
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|ClinicalTrials.gov Identifier: NCT04441086|
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
The purpose of this study is to evaluate early preliminary efficacy of the eMotion intervention in rural US adults who have experienced a myocardial infarction 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), and symptoms [depression, anxiety, pain, sleep, and fatigue]) among rural dwelling adults enrolled in cardiac rehabilitation after a first myocardial infarction.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Emotions||Behavioral: eMotion Behavioral: Healthy Living Active Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
The eMotion intervention is based on feasibility testing of the successful in-person program with critical refinement to improve accessibility. eMotion has undergone subsequent content validity testing with intervention development, self-management, cardiovascular health, and health information technology delivery experts. eMotion teaches a carefully selected repertoire of emotion regulation strategies well suited for aging rural adults following a first cardiac event in tandem with usual cardiac rehabilitation. The intervention helps patients recognize their emotions, balance emotional and physical wellbeing, and implement emotion regulation strategies effectively.
Content is delivered within the context of emotion provoking situations common in those recovering from a first MI and in maintaining MVPA. The new on-demand access to asynchronous content sessions provides didactic presentation of video and written material based on weekly needs assessments. Weekly scheduled synchronous video chat sessions, led by a nurse interventionist, will provide further individualization and application of content materials.
|Active Comparator: Healthy living active control||
Behavioral: Healthy Living Active Control
The attention control group will receive their usual cardiac rehabilitation and a comparable dose matched (to that of the eMotion intervention) of healthy living web content and video chat with a nurse.
|No Intervention: Usual care|
- Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: 1 week trials at baseline, 10 weeks, and 20 weeks ]Minutes spent in MVPA
- Depression subscale from the Depression Anxiety and Stress Scale [ Time Frame: Baseline to 20 weeks ]Symptoms of depression
- Anxiety subscale from the Depression Anxiety and Stress Scale [ Time Frame: Baseline to 20 weeks ]Symptoms of anxiety
- Stress from the Perceived Stress Scale [ Time Frame: Baseline to 20 weeks ]Perceptions of stress
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441086
|Contact: Kelly Wierenga, PhDemail@example.com|