Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 1.1. Improved minutes of moderate to vigorous physical activity 1.2. Symptom improvement (depression, anxiety, pain, sleep, and fatigue) 1.3. 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: 2.1. Improved emotion regulation (efficiency and strategy use) 2.2. Decreased perceived cardiac threat and general stress 2.3. 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.

Official Title
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Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction

Conditions
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Cardiac Event, Emotions

Intervention / Treatment
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* Behavioral: eMotion
* Behavioral: Healthy Living Active Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time major cardiac event as documented in medical record; enrolled in cardiac rehabilitation phase II program; living independently; and at least mild symptoms of depression and/or anxiety (determined by standardized measure cutpoints). Exclusion criteria: does not speak English; major Axis 1 psychiatric diagnosis (e.g. schizophrenia); terminal cancer; and legally blind

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eMotion<br>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. Intervention provided in addition to usual cardiac rehabilitation. | Behavioral: eMotion<br>* 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.<br>|
| Active Comparator: Healthy living active control<br>Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation. | Behavioral: Healthy Living Active Control<br>* 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.<br>|
| No Intervention: Usual care<br>Usual cardiac rehabilitation with no additional intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Moderate to Vigorous Physical Activity (MVPA) | Minutes spent in MVPA | 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Symptoms | Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS) | Baseline to 12 weeks, 20 weeks, and 52 weeks | 
| Change in Anxiety Symptoms | Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS) | Baseline to 12 weeks, 20 weeks, and 52 weeks | 
| Change in Pain Symptoms | Pain will be measured with the Brief Pain Inventory | Baseline to 12 weeks, 20 weeks, and 52 weeks | 
| Change in Sleep efficiency | Sleep efficiency will be a calculation of the ratio of the total sleep time to time spent in bed using the ActiGraph wGT3X-BT accelerometer | Baseline to 12 weeks, 20 weeks, and 52 weeks | 
| Change in Fatigue Symptoms | Fatigue will be measured using the Fatigue Severity Scale | Baseline to 12 weeks, 20 weeks, and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotion regulation