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

NCT07227337 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 676

Last updated 2026-05-06

No results posted yet for this study

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

Conditions

  • Post Traumatic Stress Disorder
  • Depression
  • Violence

Interventions

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.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Bushra Sabri · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227337 on ClinicalTrials.gov