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

• ClinicalTrials.gov Identifier: NCT04441086
• Recruitment Status: Completed
• First Posted: June 22, 2020
• Last Update Posted: October 24, 2023
• Sponsor: Indiana University
• Collaborators: Sigma Theta Tau International Honor Society of Nursing; Jonas Philanthropies
• Information provided by (Responsible Party): Kelly L. Wierenga, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Event; Emotions	Behavioral: eMotion; Behavioral: Healthy Living Active Control	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
• Actual Study Start Date: January 12, 2021
• Actual Primary Completion Date: May 1, 2023
• Actual Study Completion Date: October 10, 2023

Arms and Interventions

Arm	Intervention/treatment
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.	Behavioral: eMotion; 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.
Active Comparator: Healthy living active control; Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation.	Behavioral: Healthy 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.
No Intervention: Usual care; Usual cardiac rehabilitation with no additional intervention.

Outcome Measures

Primary Outcome Measures :

1. Change in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks ]
   Minutes spent in MVPA

Secondary Outcome Measures :

1. Change in Depression Symptoms [ Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks ]
   Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)
2. Change in Anxiety Symptoms [ Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks ]
   Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)
3. Change in Pain Symptoms [ Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks ]
   Pain will be measured with the Brief Pain Inventory
4. Change in Sleep efficiency [ Time Frame: 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
5. Change in Fatigue Symptoms [ Time Frame: Baseline to 12 weeks, 20 weeks, and 52 weeks ]
   Fatigue will be measured using the Fatigue Severity Scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Indiana

Indiana University Health West Hospital

Avon, Indiana, United States, 46123

Indiana University Health Bedford Hospital

Bedford, Indiana, United States, 47421

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States, 46202

Indiana University Health Tipton Hospital

Tipton, Indiana, United States, 46072

Sponsors and Collaborators

Indiana University

Sigma Theta Tau International Honor Society of Nursing

Jonas Philanthropies

Investigators

• Principal Investigator: Kelly L Wierenga, PhD; Indiana University School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kelly L. Wierenga, Assistant Professor, Nursing, Indiana University
• ClinicalTrials.gov Identifier: NCT04441086
• Other Study ID Numbers: 2002325890
• First Posted: June 22, 2020
• Last Update Posted: October 24, 2023
• Last Verified: October 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly L. Wierenga, Indiana University:

Emotion regulation

Additional relevant MeSH terms:

Myocardial Infarction; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases