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

NCT07417904 | Not Yet Recruiting

• 2 other identifiers: IRB-2025-1976K23MH126312
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Violence Risk; Early Psychosis

Keywords

early psychosis; violence risk; aggression; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Working Alliance Inventory - Short Revised (WAI-SR)

  The WAI-SR is a validated self-report measure of therapeutic alliance used to assess acceptability and engagement with the BRAVE intervention.

  Baseline, Week 24

Secondary Outcomes (3)

• Enrollment rate

  Randomization to week 24

• Columbia Initial Screen for Violence

  Baseline, Week 24

• Retention rate

  From randomization to Week 24

Study Arms (2)

Treatment As Usual (TAU)

OTHER

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

Other: Treatment As Usual (TAU)

TAU + BRAVE

EXPERIMENTAL

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); Other: Treatment As Usual (TAU)

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.

TAU + BRAVE

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.

TAU + BRAVE; Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Howard University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Aggression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Central Study Contacts

Stephanie Rolin, MD MPH

CONTACT

(202) 865-6100; stephanie.rolin@howard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: design type: stepped wedge

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 18, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)