Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT06139861
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2023-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Better Sleep Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )', 'timeFrame': 'baseline to end of treatment (0 and 2 months)', 'description': 'Validated biological and behavioral assessment; range between 0 and 11 hours, with shorter numbers indicating worse alignment between circadian biology and behavior'}, {'measure': "Change in Children's Depression Rating Scale (CDRS-R)", 'timeFrame': 'baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14', 'description': 'Validated clinician administered depression symptom severity scale; range between 17 and 133, with higher numbers indicative of greater depression severity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Adolescents', 'Sleep', 'Intervention'], 'conditions': ['Depression in Adolescence', 'Delayed Sleep Phase']}, 'descriptionModule': {'briefSummary': 'The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nExclusion Criteria:\n\n* mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; Bipolar Disorder; drug dependence\n* severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer)\n* current use of medications or herbs with known effects on sleep\n* plan to undergo or have had medication change in the last 8 weeks'}, 'identificationModule': {'nctId': 'NCT06139861', 'briefTitle': 'Better Sleep Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents', 'orgStudyIdInfo': {'id': 'R01MH129558-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01MH129558-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH129558-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01MH129558-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TranS-C', 'interventionNames': ['Behavioral: TranS-C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducation', 'interventionNames': ['Behavioral: Psychoeducation']}], 'interventions': [{'name': 'TranS-C', 'type': 'BEHAVIORAL', 'description': 'Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.', 'armGroupLabels': ['TranS-C']}, {'name': 'Psychoeducation', 'type': 'BEHAVIORAL', 'description': 'The overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.', 'armGroupLabels': ['Psychoeducation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Fatima Gonzalez', 'role': 'CONTACT', 'email': 'bettersleepstudy@ucsf.edu'}, {'name': 'Sabrina Darrow, MD', 'role': 'CONTACT', 'email': 'Sabrina.Darrow@ucsf.edu', 'phone': '(415) 476-7000'}], 'facility': 'UCSF Nancy Friend Pritzker Psychiatry Building', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Lauren Asarnow, PhD', 'role': 'CONTACT', 'email': 'Lauren.Asarnow@ucsf.edu', 'phone': '4159711533'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}