BRAVE Program for Early Psychosis

(BRAVE Trial)

SR
Overseen ByStephanie Rolin, MD MPH
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Howard University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

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
See 2 more

Exclusion Criteria

History of antisocial behavior, as assessed at baseline
Immediate risk requiring a higher level of care
I am not able to give informed consent for my treatment.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment As Usual (TAU)

Participants receive routine clinical care provided by early psychosis services

Up to 24 weeks
Weekly visits

BRAVE Intervention

Participants receive the BRAVE intervention, a manualized CBT-based behavioral intervention, in addition to treatment as usual

Weekly sessions following TAU
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BRAVE

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment As Usual (TAU)Experimental Treatment1 Intervention
Group II: TAU + BRAVEExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Howard University

Lead Sponsor

Trials
44
Recruited
15,200+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+