Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction (eMotion)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Avon, Indiana, United States, 46123
- Indiana University Health West Hospital
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Bedford, Indiana, United States, 47421
- Indiana University Health Bedford Hospital
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Indianapolis, Indiana, United States, 46202
- Indiana University Health Methodist Hospital
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Tipton, Indiana, United States, 46072
- Indiana University Health Tipton Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: eMotion
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.
|
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.
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Active Comparator: Healthy living active control
Healthy living strategies based on American Heart Association education.
Intervention provided in addition to usual cardiac rehabilitation.
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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.
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No Intervention: Usual care
Usual cardiac rehabilitation with no additional intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Moderate to Vigorous Physical Activity (MVPA)
Time Frame: 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks
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Minutes spent in MVPA
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1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depression Symptoms
Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
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Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)
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Baseline to 12 weeks, 20 weeks, and 52 weeks
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Change in Anxiety Symptoms
Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
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Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)
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Baseline to 12 weeks, 20 weeks, and 52 weeks
|
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Change in Pain Symptoms
Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
|
Pain will be measured with the Brief Pain Inventory
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Baseline to 12 weeks, 20 weeks, and 52 weeks
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Change in Sleep efficiency
Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
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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
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Baseline to 12 weeks, 20 weeks, and 52 weeks
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Change in Fatigue Symptoms
Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
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Fatigue will be measured using the Fatigue Severity Scale
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Baseline to 12 weeks, 20 weeks, and 52 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kelly L Wierenga, PhD, Indiana University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002325890
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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