Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-02 @ 11:33 AM
Study NCT ID:
NCT06404866
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satisfaction With eMotion in a Diverse Group of Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distress-Depression and Anxiety Stress Scale', 'timeFrame': 'three months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Physical Activity', 'timeFrame': 'three months', 'description': 'Change in amount of time exercising at moderate or greater intensity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emotion Regulation'], 'conditions': ['Cardiac Events', 'Emotions']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nParticipants 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.\n\nBaseline 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.\n\nEach week's content, including lessons, and surveys will last approximately 45-60 minutes, or 10 hours across the entire intervention period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Eligible if self-identifies as a woman', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-time major cardiac event as documented in the medical record\n* Lives independently\n* 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).\n\nExclusion Criteria:\n\n* Does not understand both spoken and written English\n* In palliative care or hospice\n* Legally blind'}, 'identificationModule': {'nctId': 'NCT06404866', 'briefTitle': 'Satisfaction With eMotion in a Diverse Group of Women', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Satisfaction With eMotion in a Diverse Group of Women', 'orgStudyIdInfo': {'id': '19153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eMotion Intervention', '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.', 'interventionNames': ['Behavioral: eMotion']}], 'interventions': [{'name': 'eMotion', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['eMotion Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eskenazi Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Kelly L Wierenga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kelly L. Wierenga', 'investigatorAffiliation': 'Indiana University'}}}}