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

Johns Hopkins University

Status: Enrolling

Conditions: Post Traumatic Stress Disorder; Depression; Violence

Treatments: Behavioral: BSHAPE; Other: Control (general wellness)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07227337

1R01MD018503-01A1 (U.S. NIH Grant/Contract)

IRB00504423

Details and patient eligibility

About

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

Full description

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.

Enrollment: 676 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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676 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Participants will be randomized to the Control Arm

Treatment:

Other: Control (general wellness)

BSHAPE intervention

Experimental group

Description:

Participants will be randomized to the BSHAPE intervention.

Treatment:

Behavioral: BSHAPE