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

Indiana University

Status: Completed

Conditions: Emotions; Cardiac Event

Treatments: Behavioral: Healthy Living Active Control; Behavioral: eMotion

Study type: Interventional

Funder types: Other

Identifiers

NCT04441086

2002325890

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 3 patient groups

eMotion

Experimental group

Description:

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.

Treatment:

Behavioral: eMotion

Healthy living active control

Active Comparator group

Description:

Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation.

Treatment:

Behavioral: Healthy Living Active Control

Usual care

No Intervention group

Description:

Usual cardiac rehabilitation with no additional intervention.