Actively Recruiting
Being Safe, Healthy, And Positively Empowered (BSHAPE): A Digital Multicomponent Intervention to Improve Health and Safety Outcomes Among Women With Cumulative Exposures to Violence
Led by Johns Hopkins University · Updated on 2026-05-06
676
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a digital multicomponent intervention called Being Safe, Healthy, and Positively Empowered (BSHAPE) designed to improve health and safety outcomes for women who have experienced lifetime exposures to violence and have symptoms of PTSD and/or depression. The study focuses on addressing the high risk of mental and physical health problems, including trauma impact and safety issues, among women with cumulative interpersonal violence exposure. Participants will be randomly assigned to either the BSHAPE intervention group or a control group. The BSHAPE intervention includes comprehensive assessments of violence exposure and current safety needs, alongside components aimed at reducing trauma effects such as mental health challenges and HIV/STI risk. It promotes health through psycho-education, skill building, and mindfulness-based stress reduction. The control group will receive general wellness support including nutrition information, exercise guidance, and a list of community resources. During the study, participants will be assessed at baseline, 3, 6, and 12 months for outcomes including perceived stress, depression, PTSD symptoms, self-protection behaviors, empowerment for safety, and self-care behaviors. Additional measures include safe sex behavior, mindfulness, resilience, self-efficacy, trauma coping, and emotion regulation. This study involves regular evaluations to track changes and safety outcomes over a one-year period.
CONDITIONS
Brief Title
Being Safe, Healthy, And Positively Empowered (BSHAPE) Intervention Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Female foreign-born immigrant
- Self-reported history of cumulative exposure to violence
- Presence of PTSD and/or depression symptoms
You will not qualify if you...
- Participants who do not meet all the inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 12 months
Participants receive either the BSHAPE behavioral intervention focused on trauma reduction and health promotion or control activities including nutrition and exercise guidance.
1 baseline visit and 3 follow-up visits at 3, 6, and 12 months
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
B
Bushra Sabri
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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