Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07417904
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.
Study:
NCT07417904
Study Brief:
Protocol Section:
NCT07417904