Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-04-02 @ 7:39 PM
Study NCT ID:
NCT06003361
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2023-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rise Study for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2023-08-15', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-8)', 'timeFrame': '5 weeks post-randomization', 'description': 'Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity'}, {'measure': 'Environmental Reward Observation Scale (EROS)', 'timeFrame': '5 weeks post-randomization', 'description': 'A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-8)', 'timeFrame': '10 weeks post-randomization', 'description': 'Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity'}, {'measure': 'Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': '5 and 10 weeks post-randomization', 'description': 'A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity'}, {'measure': 'World Health Organization 5-item Wellbeing Index (WHO-5)', 'timeFrame': 'Weeks 5 and 10 post-randomization', 'description': 'Validated questionnaire; a 5-item scale with raw total scores between 0 and 25 where higher scores indicate greater wellbeing'}, {'measure': 'Environmental Reward Observation Scale (EROS)', 'timeFrame': '10 weeks post-randomization', 'description': 'A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.', 'detailedDescription': 'This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥22 years old\n* Score ≥10 and \\<20 on the 8-item Patient Health Questionnaire (PHQ-8)\n* Diagnosis of Major Depression\n* Current resident of the USA\n* Oral and written fluency in English\n* Regular access to the internet via a mobile or tablet device using Android (5 or higher) or iOS (13 or higher)\n* Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form\n\nExclusion Criteria:\n\n* Must not be currently receiving or be expecting to start therapy for depression, anxiety, or sleep during study participation, or have received cognitive behavioral therapy for depression, anxiety, or sleep in the past 12-months\n* If on psychotropic medication, this must be stable for at least 60 days\n* Past or present psychosis, schizophrenia, or bipolar disorder\n* Moderate or greater suicide risk\n* Treatment-resistant depression\n* Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation\n* Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures\n* Any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities\n* Other exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT06003361', 'briefTitle': 'Rise Study for Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Big Health Inc.'}, 'officialTitle': 'Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults', 'orgStudyIdInfo': {'id': 'BH-D-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital CBT', 'description': 'digitally-delivered CBT for depression accessed via mobile app', 'interventionNames': ['Device: Digital CBT']}, {'type': 'OTHER', 'label': 'Waitlist', 'description': 'Participants will wait for 5 weeks prior to receiving the intervention', 'interventionNames': ['Other: Waitlist']}], 'interventions': [{'name': 'Digital CBT', 'type': 'DEVICE', 'description': 'An app-based intervention based on principles from cognitive behavioral therapy for depression.', 'armGroupLabels': ['Digital CBT']}, {'name': 'Waitlist', 'type': 'OTHER', 'description': 'Participants will wait for 5 weeks prior to receiving the intervention', 'armGroupLabels': ['Waitlist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94108', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Big Health Inc.', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Big Health Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}