Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:48 PM
Study NCT ID:
NCT07417904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D000374', 'term': 'Aggression'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'design type: stepped wedge'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Working Alliance Inventory - Short Revised (WAI-SR)', 'timeFrame': 'Baseline, Week 24', 'description': 'The WAI-SR is a validated self-report measure of therapeutic alliance used to assess acceptability and engagement with the BRAVE intervention.'}], 'secondaryOutcomes': [{'measure': 'Enrollment rate', 'timeFrame': 'Randomization to week 24', 'description': 'Enrollment rate defined as the proportion of eligible individuals who provide informed consent and enroll in the study.'}, {'measure': 'Columbia Initial Screen for Violence', 'timeFrame': 'Baseline, Week 24', 'description': 'The Columbia Initial Screen for Violence (CIS-V) is a self-report measure assessing violence-related thoughts and behaviors.'}, {'measure': 'Retention rate', 'timeFrame': 'From randomization to Week 24', 'description': 'Retention rate defined as the proportion of enrolled participants who complete the final study assessment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early psychosis', 'violence risk', 'aggression', 'cognitive behavioral therapy'], 'conditions': ['Violence Risk', 'Early Psychosis']}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility and acceptability of BRAVE, a manualized cognitive behavioral therapy (CBT)-based intervention designed to address dynamic risk factors for violence among young adults with early psychosis. Using a stepped-wedge randomized design, all participants will receive treatment as usual followed by the BRAVE intervention. The study will also explore changes in violence-related behaviors and treatment engagement over time.', 'detailedDescription': 'Young adults in the early phase of psychosis are at elevated risk for violent behavior, yet few behavioral interventions have been developed to address modifiable violence-related mechanisms in this population. BRAVE is a brief, manualized CBT-based intervention adapted for delivery within early intervention services.\n\nIn this stepped-wedge cluster randomized trial, all participants will begin in a treatment-as-usual condition and will be randomly and sequentially transitioned to the BRAVE intervention. Participants will receive weekly BRAVE sessions following completion of the treatment-as-usual period and will continue to receive routine clinical care throughout the study. Study assessments will be conducted at regular intervals across treatment-as-usual, intervention, and follow-up periods. Participants will also identify a collateral informant who will complete study assessments at predefined intervals.\n\nThe primary objective of this study is to evaluate the feasibility and acceptability of BRAVE. Secondary objectives include examining changes in violence-related behaviors and related clinical and psychosocial outcomes to inform future, fully powered trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young adults aged 18-30 years\n* Diagnosis of early psychosis\n* Currently receiving outpatient care through an early psychosis clinic\n* Psychiatrically stable and deemed appropriate for participation by a treating clinician\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Not fluent in English\n* History of antisocial behavior, as assessed at baseline\n* Immediate risk requiring a higher level of care'}, 'identificationModule': {'nctId': 'NCT07417904', 'acronym': 'BRAVE', 'briefTitle': 'BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Howard University'}, 'officialTitle': 'Young Adults and Violent Behavior During Early Psychosis (Aim 3)', 'orgStudyIdInfo': {'id': 'IRB-2025-1976'}, 'secondaryIdInfos': [{'id': 'K23MH126312', 'link': 'https://reporter.nih.gov/quickSearch/K23MH126312', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment As Usual (TAU)', 'description': 'Participants will receive routine clinical care provided by early psychosis services.', 'interventionNames': ['Other: Treatment As Usual (TAU)']}, {'type': 'EXPERIMENTAL', 'label': 'TAU + BRAVE', 'description': 'Participants will receive BRAVE, a manualized CBT-based behavioral intervention, in addition to treatment as usual. BRAVE consists of weekly sessions delivered within early psychosis services and targets modifiable risk factors for violence.', 'interventionNames': ['Behavioral: BRAVE (Behavioral Response Against Violence Engagement)', 'Other: Treatment As Usual (TAU)']}], 'interventions': [{'name': 'BRAVE (Behavioral Response Against Violence Engagement)', 'type': 'BEHAVIORAL', 'description': 'BRAVE is a brief, manualized cognitive behavioral therapy (CBT)-based behavioral intervention designed to address modifiable risk factors associated with violence risk among young adults with early psychosis. The intervention is delivered as weekly sessions within early psychosis services and focuses on enhancing treatment engagement, emotional regulation, cognitive flexibility, and behavioral coping strategies related to aggression and violence risk. Participants continue to receive treatment as usual throughout the study.', 'armGroupLabels': ['TAU + BRAVE']}, {'name': 'Treatment As Usual (TAU)', 'type': 'OTHER', 'description': 'Treatment as usual consists of routine outpatient clinical care provided by early psychosis services, including psychiatric medication management and psychosocial services, as determined by the treating clinical team. No study-specific intervention is delivered during this condition.', 'armGroupLabels': ['TAU + BRAVE', 'Treatment As Usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'contacts': [{'name': 'Stephanie Rolin, MD MPH', 'role': 'CONTACT', 'email': 'stephanie.rolin@howard.edu', 'phone': '(202) 865-6100'}], 'facility': 'Howard University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Stephanie Rolin, MD MPH', 'role': 'CONTACT', 'email': 'stephanie.rolin@howard.edu', 'phone': '(202) 865-6100'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to the sensitive nature of the data collected, including information related to violence risk and mental health, and the potential risk of re-identification. De-identified summary data will be reported in publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Howard University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}