Clinical trial NCT04441086: Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
Official title: Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Event
Emotions
Keywords: Emotion regulation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau International Honor Society of Nursing
name: Jonas Philanthropies
First posted: 2020-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks
Secondary outcomes:
measure: Change in Depression Symptoms
timeFrame: Baseline to 12 weeks, 20 weeks, and 52 weeks
measure: Change in Anxiety Symptoms
timeFrame: Baseline to 12 weeks, 20 weeks, and 52 weeks
measure: Change in Pain Symptoms
timeFrame: Baseline to 12 weeks, 20 weeks, and 52 weeks
measure: Change in Sleep efficiency
timeFrame: Baseline to 12 weeks, 20 weeks, and 52 weeks
measure: Change in Fatigue Symptoms
timeFrame: Baseline to 12 weeks, 20 weeks, and 52 weeks
Other outcomes:
Locations:
city: Avon
country: United States
facility: Indiana University Health West Hospital
state: Indiana
city: Bedford
country: United States
facility: Indiana University Health Bedford Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Tipton
country: United States
facility: Indiana University Health Tipton Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Kelly L Wierenga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.