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

Primary Purpose

Cardiac Event, Emotions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eMotion
Healthy Living Active Control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Event focused on measuring Emotion regulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Indiana University Health West Hospital
  • Indiana University Health Bedford Hospital
  • Indiana University Health Methodist Hospital
  • Indiana University Health Tipton Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

eMotion

Healthy living active control

Usual care

Arm 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.

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

Usual cardiac rehabilitation with no additional intervention.

Outcomes

Primary Outcome Measures

Change in Moderate to Vigorous Physical Activity (MVPA)
Minutes spent in MVPA

Secondary Outcome Measures

Change in Depression Symptoms
Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)
Change in Anxiety Symptoms
Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)
Change in Pain Symptoms
Pain will be measured with the Brief Pain Inventory
Change in Sleep efficiency
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
Fatigue will be measured using the Fatigue Severity Scale

Full Information

First Posted
June 11, 2020
Last Updated
October 23, 2023
Sponsor
Indiana University
Collaborators
Sigma Theta Tau International Honor Society of Nursing, Jonas Philanthropies
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1. Study Identification

Unique Protocol Identification Number
NCT04441086
Brief Title
Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
Acronym
eMotion
Official Title
Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
October 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Sigma Theta Tau International Honor Society of Nursing, Jonas Philanthropies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Event, Emotions
Keywords
Emotion regulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eMotion
Arm Type
Experimental
Arm 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.
Arm Title
Healthy living active control
Arm Type
Active Comparator
Arm Description
Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual cardiac rehabilitation with no additional intervention.
Intervention Type
Behavioral
Intervention Name(s)
eMotion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Living Active Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Moderate to Vigorous Physical Activity (MVPA)
Description
Minutes spent in MVPA
Time Frame
1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks
Secondary Outcome Measure Information:
Title
Change in Depression Symptoms
Description
Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)
Time Frame
Baseline to 12 weeks, 20 weeks, and 52 weeks
Title
Change in Anxiety Symptoms
Description
Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)
Time Frame
Baseline to 12 weeks, 20 weeks, and 52 weeks
Title
Change in Pain Symptoms
Description
Pain will be measured with the Brief Pain Inventory
Time Frame
Baseline to 12 weeks, 20 weeks, and 52 weeks
Title
Change in Sleep efficiency
Description
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
Time Frame
Baseline to 12 weeks, 20 weeks, and 52 weeks
Title
Change in Fatigue Symptoms
Description
Fatigue will be measured using the Fatigue Severity Scale
Time Frame
Baseline to 12 weeks, 20 weeks, and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First time major cardiac event as documented in medical record; enrolled in cardiac rehabilitation phase II program; living independently; and at least mild symptoms of depression and/or anxiety (determined by standardized measure cutpoints). Exclusion criteria: does not speak English; major Axis 1 psychiatric diagnosis (e.g. schizophrenia); terminal cancer; and legally blind
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly L Wierenga, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health West Hospital
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Indiana University Health Bedford Hospital
City
Bedford
State/Province
Indiana
ZIP/Postal Code
47421
Country
United States
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Health Tipton Hospital
City
Tipton
State/Province
Indiana
ZIP/Postal Code
46072
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34741536
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.
Results Reference
derived

Learn more about this trial

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

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