Satisfaction With eMotion in a Diverse Group of Women

NCT06404866 | Completed

• 1 other identifier: 19153
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Events; Emotions

Keywords

Emotion Regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Physical Activity

  three months

Study Arms (1)

eMotion Intervention

EXPERIMENTAL

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

Interventions

eMotion BEHAVIORAL

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.

eMotion Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible if self-identifies as a woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Kelly L Wierenga, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 8, 2024
• Study Start: June 5, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 24, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)