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

Not Applicable

Completed

• Conditions: Cardiac Event; Emotions
• Interventions: Behavioral: eMotion; Behavioral: Healthy Living Active Control

• Registration Number: NCT04441086
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Study Start: 2021-01-12
• Primary Completion: 2023-05-01
• Status Verified: 2023-10
• Study Completion: 2023-10-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eMotion	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.
Healthy living active control	Healthy Living Active Control	Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Fatigue Symptoms	Baseline to 12 weeks, 20 weeks, and 52 weeks	Fatigue will be measured using the Fatigue Severity Scale
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

Trial Locations

Locations (4)

Indiana University Health Bedford Hospital; 🇺🇸 Bedford, Indiana, United States

Indiana University Health West Hospital; 🇺🇸 Avon, Indiana, United States

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Health Tipton Hospital; 🇺🇸 Tipton, Indiana, United States