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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 30 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Young adults aged 18-30 years - Diagnosis of early psychosis - Currently receiving outpatient care through an early psychosis clinic - Psychiatrically stable and deemed appropriate for participation by a treating clinician - Able and willing to provide informed consent

Exclusion Criteria

  • Unable to provide informed consent - Not fluent in English - History of antisocial behavior, as assessed at baseline - Immediate risk requiring a higher level of care

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
design type: stepped wedge
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Treatment As Usual (TAU) 		Participants will receive routine clinical care provided by early psychosis services.
  • Other: Treatment As Usual (TAU)
    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.
Experimental
TAU + BRAVE 		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.
  • Behavioral: BRAVE (Behavioral Response Against Violence Engagement)
    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.
  • Other: Treatment As Usual (TAU)
    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.

Recruiting Locations

Howard University Hospital
Washington D.C., District of Columbia 20060
Contact:
Stephanie Rolin, MD MPH
(202) 865-6100
stephanie.rolin@howard.edu

More Details

Status
Recruiting
Sponsor
Howard University

Study Contact

Stephanie Rolin, MD MPH
(202) 865-6100
stephanie.rolin@howard.edu

Detailed Description

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. In 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. The 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.