Cardiac Event, Emotions
Conditions
Keywords
Emotion regulation
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.
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.
Interventions
BEHAVIORALeMotion
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.
BEHAVIORALHealthy 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.
Sponsors
Sigma Theta Tau International Honor Society of Nursing
Jonas Philanthropies
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. First time major cardiac event as documented in medical record; 2. enrolled in cardiac rehabilitation phase II program; 3. living independently; and 4. at least mild symptoms of depression and/or anxiety (determined by standardized measure cutpoints).
Exclusion criteria
1. does not speak English; 2. major Axis 1 psychiatric diagnosis (e.g. schizophrenia); 3. terminal cancer; and 4. legally blind
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Moderate to Vigorous Physical Activity (MVPA) | 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks | Minutes spent in MVPA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Symptoms | Baseline to 12 weeks, 20 weeks, and 52 weeks | Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS) |
| Change in Anxiety Symptoms | Baseline to 12 weeks, 20 weeks, and 52 weeks | Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS) |
| Change in Pain Symptoms | Baseline to 12 weeks, 20 weeks, and 52 weeks | Pain will be measured with the Brief Pain Inventory |
| Change in Sleep efficiency | Baseline to 12 weeks, 20 weeks, and 52 weeks | 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 |
| Change in Fatigue Symptoms | Baseline to 12 weeks, 20 weeks, and 52 weeks | Fatigue will be measured using the Fatigue Severity Scale |
Countries
United States
Outcome results
None listed