Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04589520
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stress Levels', 'timeFrame': '21 days for 30 minutes every day based on a 21-day calendar', 'description': "Participant stress levels were measured using the Perceived Stress Scale (PSS). This 10-item scale measures the degree to which a situation in someone's life is considered stressful ."}], 'secondaryOutcomes': [{'measure': 'Change in Emotional Wellbeing', 'timeFrame': '21 days for 30 minutes every day based on a 21-day calendar', 'description': 'The emotional wellness of the participants was measured using the EPOCH measure of adolescent wellbeing. This is a 20-item scale used to measure five different positive characteristics: Engagement, Perseverance, Optimism, Connectedness, and Happiness.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Mental Health Wellness 1']}, 'referencesModule': {'references': [{'pmid': '33455902', 'type': 'DERIVED', 'citation': 'Iyer L, Iyer RB, Kumar V. A Relaxation App (HeartBot) for Stress and Emotional Well-Being Over a 21-Day Challenge: Randomized Survey Study. JMIR Form Res. 2021 Jan 29;5(1):e22041. doi: 10.2196/22041.'}]}, 'descriptionModule': {'briefSummary': 'HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older.\n\nResearch Question: Does HeartBot affect the stress levels and emotional wellness in participants 14 years and older?\n\nHypothesis: Participants who use HeartBot for 21 days will see a significant decrease in their stress levels and an improvement in emotional wellness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants 14 years of age and older willing to participate in the study; parental/guardian consent in case of the student below 18 years of age.\n\nExclusion Criteria:\n\n* Individuals less than 14 years of age. As the app is available on iOS only, you need to have an iOS device to participate.'}, 'identificationModule': {'nctId': 'NCT04589520', 'briefTitle': 'The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge', 'organization': {'class': 'OTHER', 'fullName': 'Heartfulness Institute'}, 'officialTitle': 'The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge', 'orgStudyIdInfo': {'id': '2019/07/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HeartBot Group', 'description': 'The HeartBot group downloaded the app and used it daily for 21 days based on a calendar that provided them with step by step outlines of the tools for each day.', 'interventionNames': ['Behavioral: HeartBot App']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group did not download the app and experienced no change to their daily routines.'}], 'interventions': [{'name': 'HeartBot App', 'type': 'BEHAVIORAL', 'description': 'HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness to deal with daily stress and anxiety in a healthy, productive manner.', 'armGroupLabels': ['HeartBot Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48375', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ranjani B Iyer', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}], 'overallOfficials': [{'name': 'Ranjani B Iyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heartfulness Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Starting six months after publication', 'ipdSharing': 'YES', 'description': 'Publish a research paper with details on the study design, protocol, analysis of data, and report on implications to stress management and wellness tools.', 'accessCriteria': 'Access criteria IPD and any additional supporting information will be shared with the researchers furthering research in stress management and emotional wellness tools.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ranjani Iyer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Heartfulness Program for Schools', 'investigatorFullName': 'Ranjani Iyer', 'investigatorAffiliation': 'Heartfulness Institute'}}}}