Being Safe, Healthy, and Positively Empowered (BSHAPE) for foreign-born women
Being Safe, Healthy, And Positively Empowered (BSHAPE): A Digital Multicomponent Intervention to Improve Health and Safety Outcomes Among Women With Cumulative Exposures to Violence
This project will test a trauma-informed digital program (BSHAPE) to see if it improves safety, mental health, and related health risks for foreign-born immigrant women with histories of violence and PTSD or depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 676 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07227337 on ClinicalTrials.gov |
What this trial studies
This interventional trial tests BSHAPE, a trauma-informed digital multicomponent program, against a general wellness control to improve health and safety outcomes. It enrolls foreign-born immigrant women age 18 and older who report cumulative exposure to interpersonal violence and current PTSD and/or depression symptoms. BSHAPE combines comprehensive screening for violence and safety needs with modules for mental health symptom reduction, HIV/STI risk reduction, knowledge and skill building, and stress-reduction practices delivered digitally. Researchers will compare changes in safety, PTSD/depression symptoms, and related health risk behaviors between groups over the follow-up period.
Who should consider this trial
Good fit: Ideal participants are foreign-born immigrant women aged 18 or older who report cumulative exposure to interpersonal violence and current PTSD and/or depression symptoms.
Not a fit: People who are male, under 18, have no history of interpersonal violence, do not have PTSD or depression symptoms, or cannot access or use digital interventions may be unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, BSHAPE could help reduce PTSD and depression symptoms, improve personal safety, and lower HIV/STI risk among immigrant women exposed to violence.
How similar studies have performed: Previous digital, trauma-informed interventions for PTSD and depression have shown mixed but promising results, though few trials have tested comprehensive multicomponent programs specifically for foreign-born women with violence exposure.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18 or older * foreign-born immigrant woman * self-reported history of cumulative exposure to violence, and presence of PTSD and/or depression symptoms Exclusion Criteria: * Participants who don't meet the above criteria
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Bushra Sabri — Johns Hopkins University
- Study coordinator: Bushra Sabri
- Email: bsabri1@jhu.edu
- Phone: 4109557105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.