Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07227337

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Participants who do not meet all the inclusion criteria

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Outpatient Treatment

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

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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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