NCT07227337

Being Safe, Healthy, And Positively Empowered (BSHAPE) Intervention Study

Being Safe, Healthy, And Positively Empowered (BSHAPE): A Digital Multicomponent Intervention to Improve Health and Safety Outcomes Among Women With Cumulative Exposures to Violence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 676 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate a trauma informed digital multicomponent intervention design to improve health and safety outcomes for women with lifetime exposures to violence and co-occurring PTSD and/or depression symptoms

Detailed description

Individuals with cumulative exposures to interpersonal violence are at high risk for co-occurring mental and physical health problems (e.g., PTSD, HIV/STI) and safety issues such as living in unsafe households or being in unsafe relationships. The proposed research will test the efficacy of Being Safe, Healthy, and Positively Empowered (BSHAPE), an intervention designed to comprehensively assess cumulative exposures to violence, current safety needs, and includes components to reduce the impact of trauma such as poor mental health, HIV/STI risk, and to promote health through knowledge building, skill building, and stress reduction practices.

Conditions

• Post Traumatic Stress Disorder
• Depression
• Violence

Interventions

Type	Name	Description
BEHAVIORAL	BSHAPE	BSHAPE is designed to comprehensively assess cumulative exposures to violence, evaluate current safety needs, and provide components to mitigate trauma-related symptoms (e.g., mental health challenges, HIV/STI risk). It promotes health and resilience through psycho-education, skill-building, and mindfulness-based stress reduction practices.
OTHER	Control (general wellness)	The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.

Timeline

• Start date: 2025-11-05
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-11-12
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States