Early Psychosis, Violence Risk
Conditions
Keywords
early psychosis, violence risk, aggression, cognitive behavioral therapy
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.
Detailed 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.
Interventions
OTHERTreatment As Usual (TAU)
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.
BEHAVIORALBRAVE (Behavioral Response Against Violence Engagement)
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.
Sponsors
Howard University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
design type: stepped wedge
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Young adults aged 16-30 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Working Alliance Inventory - Short Revised (WAI-SR) | Baseline, Week 24 | The WAI-SR is a 12-item self-report measure of therapeutic alliance. Items assess agreement on therapeutic goals and tasks and the participant-therapist bond. Total scores range from 12 to 60, with higher scores indicating a stronger therapeutic alliance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | Randomization to week 24 | Enrollment rate defined as the proportion of eligible individuals who provide informed consent and enroll in the study. |
| Columbia Initial Screen for Violence | Baseline, Week 24 | The Columbia Initial Screen for Violence is a self-report measure assessing violence-related thoughts and behaviors. Items assess whether specific violence-related thoughts or behaviors occurred and, where applicable, their frequency during the assessment period. Outcomes will be reported as the presence and frequency of violence-related thoughts and behaviors; higher frequencies indicate more frequent violence-related experiences. |
| Retention rate | From randomization to Week 24 | Retention rate defined as the proportion of enrolled participants who complete the final study assessment. |
Countries
United States
Contacts
CONTACTStephanie Rolin, MD MPH
Outcome results
None listed