Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-26 @ 7:11 PM
Study NCT ID:
NCT07081061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Workplace Productivity', 'timeFrame': 'Baseline, 45 days, 90 days', 'description': 'Workplace productivity will be measured by the Work Productivity and Activity Impairment Questionnaire (WPAI) and reported for both groups.'}, {'measure': 'Sleep', 'timeFrame': 'Baseline, 45 days, 90 days', 'description': 'Sleep quality will be measured by the Jenkins Sleep Scale (JSS-4) and reported for both groups.'}, {'measure': 'Stress', 'timeFrame': 'Baseline, 45 days, 90 days', 'description': 'Stress levels will be measured by the Perceived Stress Scale (PSS-10) and reported for both groups.'}], 'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '90 days', 'description': 'Recruitment rates for study participation'}, {'measure': 'Adherence', 'timeFrame': '90 days', 'description': 'Adherence rates to study procedures'}], 'secondaryOutcomes': [{'measure': 'GAD-7', 'timeFrame': 'Baseline, 45 days, 90 days', 'description': 'Anxiety will be measured by the Generalized Anxiety Disorder Scale (GAD-7), ranging from 0 (no anxiety) to 21 (severe anxiety). The percentage of participants who achieved a minimal clinically important difference (MCID) of 4 points or more will also be reported for each group, as based on literature.'}, {'measure': 'PHQ-9', 'timeFrame': 'Baseline, 45 days, 90 days', 'description': 'Depression will be measured by the Patient Health Questionnaire (PHQ-9), ranging from 0 (no depression) to 27 (severe depression). The percentage of participants who achieved a minimal clinically important difference (MCID) of 5 points or more will also be reported for each group, as based on literature.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression, Anxiety', 'Mental Health Issue', 'Mental Health Wellness 2']}, 'descriptionModule': {'briefSummary': 'A digital mental health intervention (BetterHelp, Mountain View, CA) provides users with access to online therapy care for treatment of depression and anxiety. This feasibility randomized controlled trial compares clinical outcomes of an intervention group, who will enroll in the digital mental health platform, to a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Has moderate or severe baseline anxiety or depression, as defined by GAD-7 ≥ 10 or PHQ-9 ≥ 10, respectively\n* Based in the US\n* Fluent in the English language\n* Has an email account to receive and complete online surveys\n* Has access to a smartphone, tablet or computer\n* Able to understand and provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or plan on becoming pregnant in the next 6 months\n* Has no or mild baseline anxiety or depression, as defined by GAD-7 \\< 10 and PHQ-9 \\< 10, respectively'}, 'identificationModule': {'nctId': 'NCT07081061', 'briefTitle': 'Clinical Outcomes of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teladoc Health'}, 'officialTitle': 'A Feasibility Randomized Controlled Trial Evaluating the Effectiveness of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety', 'orgStudyIdInfo': {'id': 'BH2294015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants enrolled in a digital mental health platform, which provided access to licensed therapists, group therapy sessions, and a library of educational articles.', 'interventionNames': ['Other: BetterHelp']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants were not enrolled in a digital mental health platform, but continued their standard routine or care as needed.'}], 'interventions': [{'name': 'BetterHelp', 'type': 'OTHER', 'description': 'Use program as needed for 16 weeks', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mindy Hong, PhD', 'role': 'CONTACT', 'email': 'mindy.hong@teladochealth.com', 'phone': '615-498-8308'}, {'name': 'Mona Barman, PhD', 'role': 'CONTACT', 'email': 'mona.barman@teladochealth.com'}], 'overallOfficials': [{'name': 'Mindy Hong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Teladoc Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teladoc Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BetterHelp', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}