Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT06439420
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of consent to screening procedures', 'timeFrame': 'Baseline (Day 1)', 'description': 'Number of participants that consent to screening procedures'}, {'measure': 'Rate of those eligible enrolling', 'timeFrame': 'Baseline (Day 1)', 'description': 'Number of participants that are eligible to enroll to the protocol'}, {'measure': 'Rate of baseline assessment completion', 'timeFrame': 'Week 1', 'description': 'Number of participants that complete the baseline assessment'}, {'measure': 'Rate of post-intervention assessment completion', 'timeFrame': 'Week 6', 'description': 'The number of participants that complete the post-intervention assessment'}, {'measure': 'Rate of follow-up assessment completion', 'timeFrame': 'Week 18', 'description': 'The number of participants that complete the follow-up assessment'}, {'measure': 'Rate of intervention attrition', 'timeFrame': 'Week 6', 'description': 'The number of participants that do not complete the CBT-I intervention'}, {'measure': 'Acceptability of quantity of assessments', 'timeFrame': 'Week 18', 'description': 'Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best'}, {'measure': 'Acceptability of timing of assessments', 'timeFrame': 'Week 18', 'description': 'Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best'}, {'measure': 'Acceptability of duration of assessments', 'timeFrame': 'Week 18', 'description': 'Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Tumor', 'Insomnia', 'Glioma', 'Sleep'], 'conditions': ['Primary Brain Tumor', 'Glioblastoma', 'Astrocytoma', 'Oligodendroglioma', 'Meningioma', 'Primary Central Nervous System (CNS) Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study seeks to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population. In the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary brain tumor diagnosis (grade I-IV)\n* \\>/=2weeks post-cranial resection (if applicable)\n* \\>/=1 month post-radiation therapy (if applicable)\n* Able to understand, speak, and read English\n* Absence of major cognitive concerns\n* Meet Diagnostic and statistical manual of mental disorders version 5 (DSM-V) diagnostic criteria for insomnia\n* Reliable internet connection\n\nExclusion Criteria:\n\n* Major communication difficulties that would prohibit effective intervention\n* Inability to attend weekly virtual group meetings\n* Inability to understand and provide informed consent\n* Currently a prisoner or residing in a correctional facility'}, 'identificationModule': {'nctId': 'NCT06439420', 'acronym': 'CBT-I in PBT', 'briefTitle': 'CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial', 'orgStudyIdInfo': {'id': 'MCC-23-20323'}, 'secondaryIdInfos': [{'id': 'HM20028336', 'type': 'OTHER', 'domain': 'Virginia Commonwealth University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth Cognitive Behavioral Therapy for Insomnia', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Insomnia']}, {'type': 'NO_INTERVENTION', 'label': 'Enhanced Treatment as Usual'}], 'interventions': [{'name': 'Cognitive Behavioral Therapy for Insomnia', 'type': 'BEHAVIORAL', 'description': 'CBT-I is a non-pharmacological approach to treating sleep disturbance consisting of educational, behavioral, and cognitive intervention components with evidence-based strategies including sleep efficiency, stimulus control, and sleep hygiene modification. CBT-I includes at least 6 group sessions, each approximately 90 minutes in length, delivered over 6 weeks via telehealth.', 'armGroupLabels': ['Telehealth Cognitive Behavioral Therapy for Insomnia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Ashlee Loughan, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are no plans to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}