Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-01 @ 7:42 PM
Study NCT ID:
NCT05061966
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2021-09-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Digital Wellbeing Project
Sponsor:
Organization:
Raw JSON
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A mean score was computed for each subscale, with higher values indicating greater endorsement of each respective stress appraisal.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Identity Affirmation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Resource Website', 'description': 'The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.\n\nControl: The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.'}, {'id': 'OG001', 'title': 'Immi', 'description': 'The intervention is a novel and scalable web application designed to provide sexual and gender minority youth with tools for affirming their identity and coping with minority stress.\n\nimmi: The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.08', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-week follow-up', 'description': 'The Lesbian, Gay and Bisexual Positive Identity Measure-Authenticity Subscale has a scoring range from 1 to 7 (1=strongly disagree to 7=strongly agree). 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Scores were computed by summing the items. 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A summed score was computed, where higher scores indicate greater depression symptomatology.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognitive and Behavioral Coping Skills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Resource Website', 'description': 'The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.\n\nControl: The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.'}, {'id': 'OG001', 'title': 'Immi', 'description': 'The intervention is a novel and scalable web application designed to provide sexual and gender minority youth with tools for affirming their identity and coping with minority stress.\n\nimmi: The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).'}], 'classes': [{'title': 'Self-distraction', 'categories': [{'measurements': [{'value': '3.23', 'spread': '.65', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '.65', 'groupId': 'OG001'}]}]}, {'title': 'Active coping', 'categories': [{'measurements': [{'value': '2.47', 'spread': '.72', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '.84', 'groupId': 'OG001'}]}]}, {'title': 'Emotional support', 'categories': [{'measurements': [{'value': '2.43', 'spread': '.94', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '.94', 'groupId': 'OG001'}]}]}, {'title': 'Instrumental support', 'categories': [{'measurements': [{'value': '2.30', 'spread': '.87', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '.90', 'groupId': 'OG001'}]}]}, {'title': 'Venting', 'categories': [{'measurements': [{'value': '2.42', 'spread': '.82', 'groupId': 'OG000'}, {'value': '2.48', 'spread': '.86', 'groupId': 'OG001'}]}]}, {'title': 'Positive reframing', 'categories': [{'measurements': [{'value': '2.25', 'spread': '.78', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '.86', 'groupId': 'OG001'}]}]}, {'title': 'Planning', 'categories': [{'measurements': [{'value': '2.56', 'spread': '.86', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '.83', 'groupId': 'OG001'}]}]}, {'title': 'Acceptance', 'categories': [{'measurements': [{'value': '2.73', 'spread': '.77', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '.77', 'groupId': 'OG001'}]}]}, {'title': 'Self-blame', 'categories': [{'measurements': [{'value': '2.76', 'spread': '.88', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '.87', 'groupId': 'OG001'}]}]}, {'title': 'Substance use', 'categories': [{'measurements': [{'value': '1.38', 'spread': '.78', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '.74', 'groupId': 'OG001'}]}]}, {'title': 'Behavioral disengagement', 'categories': [{'measurements': [{'value': '1.99', 'spread': '.82', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-week follow-up', 'description': 'The Brief COPE inventory is comprised of 11 subscales: Self-distraction; Active coping; Emotional support; Instrumental support; Venting; Positive reframing; Planning; Acceptance; Self-blame; Substance use; and, Behavioral disengagement. Participants answered each subscale using a 4-point scale (1="I haven\'t been doing this at all" to 4="I\'ve been doing this a lot"). A mean score was computed for each subscale, with higher values indicating greater use of that coping skill.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Online Resource Website', 'description': 'The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.\n\nControl: The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.'}, {'id': 'FG001', 'title': 'Immi', 'description': 'The intervention is a novel and scalable web application designed to provide sexual and gender minority youth with tools for affirming their identity and coping with minority stress.\n\nimmi: The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Online Resource Website', 'description': 'The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.\n\nControl: The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.'}, {'id': 'BG001', 'title': 'Immi', 'description': 'The intervention is a novel and scalable web application designed to provide sexual and gender minority youth with tools for affirming their identity and coping with minority stress.\n\nimmi: The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.42', 'spread': '1.51', 'groupId': 'BG000'}, {'value': '16.56', 'spread': '1.46', 'groupId': 'BG001'}, {'value': '16.49', 'spread': '1.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Multiple gender identities', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'Single gender identity', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-14', 'size': 979752, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-20T11:51', 'hasProtocol': True}, {'date': '2021-10-14', 'size': 176181, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-20T11:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2021-09-14', 'resultsFirstSubmitDate': '2022-07-20', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-01', 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coping Self-efficacy', 'timeFrame': '4-week follow-up', 'description': 'The Stress Appraisals Measure for Adolescents includes three subscales (Challenge subscale; Threat subscale; Resources subscale). Each of these subscales is answered on a 5-point scale (1=strongly disagree to 5=strongly agree). A mean score was computed for each subscale, with higher values indicating greater endorsement of each respective stress appraisal.'}], 'secondaryOutcomes': [{'measure': 'Identity Affirmation', 'timeFrame': '4-week follow-up', 'description': 'The Lesbian, Gay and Bisexual Positive Identity Measure-Authenticity Subscale has a scoring range from 1 to 7 (1=strongly disagree to 7=strongly agree). A mean score was computed, whereby greater values indicate greater feelings of authenticity.'}, {'measure': 'Internalization of Minority Stress', 'timeFrame': '4-week follow-up', 'description': 'The Coping with Discrimination Scale- Internalization Subscale has a scoring range from 1 to 6 (1=never to 6=always). We computed a mean score, where higher scores indicate greater internalization of blame for minority stress'}, {'measure': 'Sense of Belonging to the Queer Community', 'timeFrame': '4-week follow-up', 'description': 'The Thwarted Belongingness subscale of the Interpersonal Needs Questionnaire is a 5-item scale that is answered on a 7-point scale (1=not at all true" to 7=very true for me). We computed a sum score ranging from 5 to 35, where higher scores indicate a lack of sense of belonging'}, {'measure': 'Anxiety Symptoms', 'timeFrame': '4-week follow-up', 'description': 'The General Anxiety Disorder-7 scale has a range from 0 to 21. Scores were computed by summing the items. Higher scores indicate greater anxiety symptomatology.'}, {'measure': 'Depression Symptoms', 'timeFrame': '4-week follow-up', 'description': 'The Patient Health Questionnaire-8 inventory has a range from 0 to 24. A summed score was computed, where higher scores indicate greater depression symptomatology.'}, {'measure': 'Cognitive and Behavioral Coping Skills', 'timeFrame': '4-week follow-up', 'description': 'The Brief COPE inventory is comprised of 11 subscales: Self-distraction; Active coping; Emotional support; Instrumental support; Venting; Positive reframing; Planning; Acceptance; Self-blame; Substance use; and, Behavioral disengagement. Participants answered each subscale using a 4-point scale (1="I haven\'t been doing this at all" to 4="I\'ve been doing this a lot"). A mean score was computed for each subscale, with higher values indicating greater use of that coping skill.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual and Gender Minorities'], 'conditions': ['Mental Health']}, 'referencesModule': {'references': [{'pmid': '35916700', 'type': 'DERIVED', 'citation': 'Bauermeister J, Choi SK, Bruehlman-Senecal E, Golinkoff J, Taboada A, Lavra J, Ramazzini L, Dillon F, Haritatos J. An Identity-Affirming Web Application to Help Sexual and Gender Minority Youth Cope With Minority Stress: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Aug 1;24(8):e39094. doi: 10.2196/39094.'}]}, 'descriptionModule': {'briefSummary': 'This goal of this randomized control trial is to test whether a web application that provides sexual and gender minority youth ages 13-19 (N=200) with tools for affirming their identities and coping with minority stress can affect key psychosocial outcomes, such as coping self-efficacy and symptoms of anxiety and depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are between 13-19 years of age (inclusive)\n2. Self-identify as a sexual or gender minority\n3. Are English literate\n4. Reside within the United States\n5. Have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet\n6. Willingness to participate in study activities\n\nExclusion Criteria:\n\n1. Not between 13-19 years of age (inclusive)\n2. Does not self-identify as a sexual or gender minority\n3. Is not English literate\n4. Does not reside within the United States\n5. Does not have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet\n6. Unwilling to participate in study activities'}, 'identificationModule': {'nctId': 'NCT05061966', 'briefTitle': 'The Digital Wellbeing Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Piloting a Web App for Sexual and Gender Minority Youth Mental Health', 'orgStudyIdInfo': {'id': '849509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Online Resource website', 'description': 'The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'immi', 'description': 'The intervention is a novel and scalable web application designed to provide sexual and gender minority youth with tools for affirming their identity and coping with minority stress.', 'interventionNames': ['Behavioral: immi']}], 'interventions': [{'name': 'immi', 'type': 'BEHAVIORAL', 'description': 'The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).', 'armGroupLabels': ['immi']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.', 'armGroupLabels': ['Online Resource website']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jose A Bauermeister, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset.', 'ipdSharing': 'YES', 'description': 'Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset.', 'accessCriteria': 'The de-identified data from this project will be available through individual requests directed to the Principal Investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'HopeLab Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}