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

Howard University

Status: Not yet enrolling

Conditions: Early Psychosis; Violence Risk

Treatments: Other: Treatment As Usual (TAU); Behavioral: BRAVE (Behavioral Response Against Violence Engagement)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07417904

IRB-2025-1976

K23MH126312 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment As Usual (TAU)

Other group

Description:

Participants will receive routine clinical care provided by early psychosis services.

Treatment:

Other: Treatment As Usual (TAU)

TAU + BRAVE

Experimental group

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.

Treatment:

Behavioral: BRAVE (Behavioral Response Against Violence Engagement)

Other: Treatment As Usual (TAU)