Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Being Safe, Healthy, and Positively Empowered (BSHAPE) for foreign-born women

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

Run by Johns Hopkins University · NCT07227337 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment676 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations1 site (Baltimore, Maryland)
StatusRecruiting
StartedNovember 5, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedMay 6, 2026
Trial IDNCT07227337 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.