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

NCT ID: NCT07227337

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

676 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2028-12-31

Brief Summary

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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

Detailed Description

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Individuals with cumulative exposures to interpersonal violence are at high risk for co-occurring mental and physical health problems (e.g., PTSD, HIV/STI) and safety issues such as living in unsafe households or being in unsafe relationships. The proposed research will test the efficacy of Being Safe, Healthy, and Positively Empowered (BSHAPE), an intervention designed to comprehensively assess cumulative exposures to violence, current safety needs, and includes components to reduce the impact of trauma such as poor mental health, HIV/STI risk, and to promote health through knowledge building, skill building, and stress reduction practices.

Conditions

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Post Traumatic Stress Disorder Depression Violence

Keywords

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Post Traumatic Stress Disorder (PTSD) Depression Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Arm

Participants will be randomized to the Control Arm

Group Type ACTIVE_COMPARATOR

Control (general wellness)

Intervention Type OTHER

The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.

BSHAPE intervention

Participants will be randomized to the BSHAPE intervention.

Group Type EXPERIMENTAL

BSHAPE

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Control (general wellness)

The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bushra Sabri

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bushra Sabri

Role: CONTACT

Phone: 4109557105

Email: [email protected]

Other Identifiers

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1R01MD018503-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00504423

Identifier Type: -

Identifier Source: org_study_id