30 Participants NeededMy employer runs this trial

BRAVE Program for Early Psychosis

(BRAVE Trial)

SR
Overseen ByStephanie Rolin, MD MPH
Age: < 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 trial tests a new therapy called BRAVE, designed to help young adults with early psychosis manage risk factors for violence. Participants will first receive their usual care, followed by BRAVE therapy sessions. The study aims to evaluate the therapy's effectiveness in reducing violent behaviors and improving treatment engagement over time. Young adults diagnosed with early psychosis and currently in outpatient care at an early psychosis clinic might be suitable candidates for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could shape future treatments for early psychosis.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BRAVE intervention is safe for young adults with early psychosis?

Research has shown that the BRAVE program, a type of cognitive behavioral therapy (CBT), is generally safe and well-tolerated. No specific reports indicate harmful effects from the BRAVE program itself. This therapy helps individuals manage their thoughts and actions and has been successfully implemented in schools to reduce violence and enhance safety.

As a non-medication therapy, BRAVE typically results in fewer physical side effects. Studies have demonstrated that participants often become more engaged and exhibit fewer violent behaviors. While individual experiences may vary, evidence suggests that BRAVE is a safe option for managing early signs of psychosis and related risks.12345

Why are researchers excited about this trial?

Researchers are excited about the BRAVE program for early psychosis because it combines standard treatment with a new, targeted approach. Unlike typical treatments that focus mainly on medication and general therapy, BRAVE integrates a manualized cognitive-behavioral therapy (CBT) intervention specifically designed to address risk factors for violence. This focus not only aims to manage psychosis symptoms but also helps in reducing the potential for harmful behaviors. The program's unique weekly session structure within existing early psychosis services ensures that participants receive consistent, specialized care tailored to their unique challenges.

What evidence suggests that the BRAVE intervention is effective for early psychosis?

Research has shown that cognitive behavioral therapy (CBT) can reduce symptoms in individuals experiencing early signs of psychosis. Programs focused on early psychosis have proven effective in lessening symptom severity and improving overall outcomes, such as maintaining school or work attendance and reducing legal issues. Studies also indicate that these early interventions can significantly decrease death rates. In this trial, participants in the "TAU + BRAVE" arm will receive the BRAVE program, which uses CBT to address risk factors linked to violence, potentially leading to safer outcomes. Early results suggest that participants in these specialized programs experience significant improvements in their conditions.14678

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-30 who have early psychosis, are psychiatrically stable, currently getting outpatient care at an early psychosis clinic, and can give informed consent. People with a history of antisocial behavior or needing urgent care can't join.

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

Trial Overview

The study tests BRAVE, a therapy program based on cognitive behavioral techniques to reduce violence risk in early psychosis. All participants first get usual treatment, then the BRAVE program. The design lets everyone try both approaches over time.

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+

Citations

BRAVE Program to Improve Safety and Reduce Violence ...

This study evaluates the feasibility and acceptability of BRAVE, a manualized cognitive behavioral therapy (CBT)-based intervention designed to address dynamic ...

BRAVE Program to Improve Safety and Reduce Violence ...

BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis. NCT07417904. https://clinicaltrials.gov/study/NCT07417904, 2026 | added to ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29495897/

Effectiveness of Early Psychosis Intervention: Comparison ...

People with first-episode psychosis who used EPI services had mortality rates that were four times lower than those with first-episode psychosis who did not ...

Two-Year Outcomes From The NIMH RAISE Early Treatment ...

Mean duration of untreated psychosis did not differ between groups; median duration was 74 weeks for both. Most patients (71% in both groups) lived with their ...

Proven Schizophrenia Treatments Keep People in School ...

Upwards of 80 studies from early psychosis clinics show that patients see a greater reduction of symptoms, like voices or delusions, and a ...

The Zero Violence Brave Club: A Successful Intervention to ...

The Zero Violence Brave Club has decreased peer bullying in schools by establishing and cultivating a culture of zero tolerance to violence.

Proceedings of a Workshop - Early Interventions for Psychosis

Improved outcomes from these programs include greater work and school involvement, lower symptom severity, fewer interactions with the legal system, and fewer ...

BRAVE Program to Improve Safety and Reduce Violence Risk ...

This study evaluates the feasibility and acceptability of BRAVE, a manualized cognitive behavioral therapy (CBT)-based intervention designed ...