BSHAPE Intervention for Domestic Violence

(BSHAPE Trial)

Overseen By Bushra Sabri

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Not foreign-born, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

676 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital program called BSHAPE, designed to assist women who have faced violence and are experiencing symptoms of PTSD (post-traumatic stress disorder) or depression. The goal is to determine if this program can improve their health and safety. Participants will be divided into two groups: one receiving the BSHAPE intervention and the other serving as a control group. Women who are foreign-born immigrants, have experienced violence, and show signs of PTSD or depression may be well-suited for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for women facing similar challenges.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the BSHAPE intervention is safe for participants?

In a previous study, the BSHAPE program showed positive results for women who experienced violence. Research has shown that this digital program is safe and easy to use. Participants found it manageable and straightforward. The study reported no serious side effects, suggesting that BSHAPE is a safe option for helping women improve their health and safety after experiencing violence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BSHAPE intervention is unique because it approaches domestic violence by focusing on behavioral and supportive strategies, rather than relying on traditional methods like legal action or counseling alone. Researchers are excited about BSHAPE because it integrates personalized support plans and empowerment techniques to help individuals develop healthier relationship dynamics. This innovative approach could provide more sustainable and impactful outcomes for those affected by domestic violence, potentially offering a new standard of care.

What evidence suggests that the BSHAPE intervention could be effective for improving health and safety outcomes for women with lifetime exposures to violence?

Research shows that the BSHAPE program, which participants in this trial may receive, might help women who have faced violence and are dealing with PTSD or depression. Studies have found that digital programs like BSHAPE can make women at risk of partner violence feel safer and improve their mental health. The program uses techniques like mindfulness, which can lower stress and boost mental well-being. By using these methods, BSHAPE aims to give women practical tools to improve their health and safety. While direct evidence of BSHAPE's success is still being gathered, the program is based on proven methods to support women facing these challenges. ^{1 3 6 7 8}

Who Is on the Research Team?

Bushra Sabri

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for women who have experienced violence and are currently dealing with PTSD or depression. Participants should be comfortable using digital tools as the intervention is delivered online.

Inclusion Criteria

I am 18 years old or older.

I am a woman born outside of this country.

I have been exposed to violence and experience symptoms of PTSD or depression.

Exclusion Criteria

Participants who don't meet the above criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BSHAPE intervention or are assigned to the control arm

12 months

Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BSHAPE

Trial Overview The study tests a digital, trauma-informed program called BSHAPE aimed at improving health and safety for women affected by violence. It's compared to a general wellness program to see which is more effective.

How Is the Trial Designed?

Group I: BSHAPE intervention Experimental Treatment 1 Intervention

Participants will be randomized to the BSHAPE intervention.

Group II: Control Arm Active Control 1 Intervention

Participants will be randomized to the Control Arm

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8595858/

Development, Feasibility, Acceptability and Preliminary ... - PMC Cumulative trauma exposures can have a profound effect on women's health and well-being. Black immigrant women are disproportionately affected by cumulative ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442100327X

Development, feasibility, acceptability and preliminary ... Cumulative trauma exposures can have a profound effect on women's health and well-being. Black immigrant women are disproportionately affected by cumulative ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11396022/

The digital MySteps intervention for abused women at risk ... Firearms are the leading cause of victimization of abused women by intimate partner homicide and intimate partner homicide-suicides in the ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-11930-2

A technology-based intervention to improve safety, mental ... Intimate partner violence (IPV) disproportionately affects immigrant women, an understudied and underserved population in need for ...

5. mdpi.com mdpi.com/1660-4601/19/19/12714

Using Mindfulness to Improve Mental Health Outcomes of ... Immigrant women are disproportionately affected by intimate partner violence (IPV), which poses risk for mental health problems, such as PTSD and depression ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07227337

Being Safe, Healthy, And Positively Empowered (BSHAPE) ... ... Intervention to Improve Health and Safety Outcomes Among Women With Cumulative Exposures to Violence. Conditions. Post Traumatic Stress ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38330368/

A digital multicomponent intervention for immigrant women ... This pilot trial of BSHAPE showed promising results for immigrant women with lifetime exposures to violence, poor mental health, and HIV risk.

8. psycnet.apa.org psycnet.apa.org/fulltext/2024-50863-001.pdf?sr=1

The Being Safe, Health and Positively Empowered Pilot ... multicomponent digital intervention (BSHAPE) to improve health and safety outcomes for immigrant women with cumulative violence exposures, posttraumatic ...