Recruiting
Being Safe, Healthy, And Positively Empowered (BSHAPE) Intervention Study
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
ClinicalTrials.gov IDNCT07227337
PhaseNA
Enrollment676
SponsorJohns Hopkins University
Age18 Years
SexFEMALE
Conditions studied
Post Traumatic Stress Disorder, Depression, Violence
About this study
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
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.
Primary outcomes
- Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10) (Baseline (1st month), 3, 6 and 12 months)
- Depression as Assessed by The Patient Health Questionnaire-9 (PHQ-9) (Baseline (1st month), 3, 6 and 12 months)
- PTSD as Assessed by The PTSD Checklist-Civilian Version (PCL-C) (Baseline (1st month), 3, 6 and 12 months)
- Self-Protection Behavior Checklist (Baseline (1st month), 3, 6 and 12 months)
- Empowerment for Safety as Assessed by The Adapted Measure of Victim Empowerment Related to Safety (MOVERS) (Baseline (1st month), 3, 6 and 12 months)
- Self-Care Behaviors as Assessed by The Mindful Self-Care Scale (MSCS) and The Behavioral Activation for Depression Scale-Short Form (BADS-SF) (Baseline (1st month), 3, 6 and 12 months)
Eligibility information
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
Study locations
- Johns Hopkins University, Baltimore, Maryland 21205 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.