Satisfaction With eMotion in a Diverse Group of Women

The eMotion intervention, developed by the PI, provides training on multiple emotion regulation skills based on leading theories and evidence-based emotion regulation interventions. After initial pilot testing of eMotion, the investigators revised the intervention to make it more relevant to women from diverse backgrounds, as these women are disproportionately impacted by social determinants of health that complicate their recovery. It is important to revise the intervention to be acceptable to women from diverse backgrounds and to address their unique needs. The investigators want to explore if women from diverse backgrounds find the revised intervention relevant, meaningful, and easy to understand and apply to their lives. Their feedback will help investigators further revise the intervention to make it acceptable for this population.

Study Overview

• Status: Completed
• Conditions: Emotions; Cardiac Events
• Intervention / Treatment: Behavioral: eMotion

Detailed Description

This is a single-group study assessing participation satisfaction with the 10-week eMotion intervention. 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 adults following a first cardiac event.

Participants will complete one lesson per week. The weekly education targets women and contains personalized content via diverse lesson narratives. Each week, participants listen to scripted sessions they can complete on their own time regarding each weekly topic (lasting about 30 minutes). At the end of the week, participants meet individually with a study team member virtually to discuss the same subject. The lessons will be comprised of rich emotion regulation strategies selected based on the efficacy and preferences of middle-aged and older adults. The 10 lessons covered are, 1) safe exercise guidelines and strategies, 2) why emotions matter and identifying emotions, 3) becoming an emotion detective, 4) mindful walking, 5) selecting and changing situations, 6) evaluating a challenge and responding, 7) choosing what to pay attention to, 8) thinking positively, 9) emotional responses for change, and 10) changing strategies and recognizing strengths.

Baseline and concluding surveys will be completed by participants that will take approximately 20 minutes. The baseline and concluding measures will help investigators characterize our sample and further understand risk factors that may contribute to dissatisfaction or confusion. After each week's lessons, each participant will be sent an individualized survey link to complete an IU RedCap survey with questions covering participant satisfaction with the eMotion intervention. The intervening surveys (weeks 2-9) should take approximately 10 minutes to complete each week.

Each week's content, including lessons, and surveys will last approximately 45-60 minutes, or 10 hours across the entire intervention period.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• First-time major cardiac event as documented in the medical record
• Lives independently
• Has at least mild symptoms of depression (determined by Patient Health Questionnaire-8 [PHQ-8] scores of 5 or greater) and/or at least mild symptoms of anxiety (determined by the General Anxiety Disorder [GAD-7] scores of 5 or greater).

Exclusion Criteria:

• Does not understand both spoken and written English
• In palliative care or hospice
• Legally blind

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: eMotion Intervention; This is a single-group study assessing participation satisfaction with the 10-week eMotion intervention. 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 adults following a first cardiac event.

Behavioral: eMotion; Participants will complete one lesson per week. The weekly education is targeted to women and contains personalized content via a variety of diverse lesson narratives. Each week participants listen to scripted sessions they can complete on their own time regarding each of the weekly topics (lasting about 30 minutes). At the end of the week, they then meet individually with a study team member virtually to discuss the same subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress-Depression and Anxiety Stress Scale	Changes in the level of distress over time. The minimum value (Normal):0 The maximum value (extremely severe): 42 Higher scores equate to worse outcome.	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Change in amount of time exercising at moderate or greater intensity	three months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Emotion Regulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 19153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No