BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Howard University
Study ID
NCT07417904
Status
Not Yet Recruiting

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Conditions

  • Early Psychosis
  • Violence Risk

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • BRAVE (Behavioral Response Against Violence Engagement) — BEHAVIORAL
    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.
  • Treatment As Usual (TAU) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 16, 2026
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Other: Treatment As Usual (TAU)
    Participants will receive routine clinical care provided by early psychosis services.
  • 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.

Primary Outcome Measure

Working Alliance Inventory - Short Revised (WAI-SR) [ Time Frame: Baseline, Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Howard University HospitalWashington D.C.District of Columbia20060
Stephanie Rolin, MD MPH
[email protected]
(202) 865-6100

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Howard University Hospital· Washington D.C., DC

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