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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07227337
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BSHAPE — 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.
  • Control (general wellness) — OTHER
    The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.

Study Details

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

Key Dates

Start date
Nov 5, 2025
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
676 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Control Arm
    Participants will be randomized to the Control Arm
  • Experimental: BSHAPE intervention
    Participants will be randomized to the BSHAPE intervention.

Primary Outcome Measure

Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10) [ Time Frame: Baseline (1st month), 3, 6 and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205-

Find similar trials in Baltimore, MD

By condition
DepressionPTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Johns Hopkins University· Baltimore, MD

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