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Recruiting NCT07227337

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

No phase Interventional Post Traumatic Stress Disorder Depression Violence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BSHAPE, Control (general wellness).
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder, Depression, Violence. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Being Safe, Healthy, And Positively Empowered (BSHAPE): A Digital Multicomponent Intervention to Improve Health and Safety Outcomes Among Women With Cumulative Exposures to Violence

Overview

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

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.

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 outcome measures

  • Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • Depression as Assessed by The Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • PTSD as Assessed by The PTSD Checklist-Civilian Version (PCL-C) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • Self-Protection Behavior Checklist [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • Empowerment for Safety as Assessed by The Adapted Measure of Victim Empowerment Related to Safety (MOVERS) [Time frame: 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) [Time frame: Baseline (1st month), 3, 6 and 12 months]
Secondary outcome measures (7)
  • Safe Sex Behavior as Assessed by The Safe Sex Behavior Questionnaire (SSBQ) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • Cognitive and Affective Mindfulness as Assessed by The Adapted Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • Resilience as Assessed by The Brief Trauma Resiliency Scale (BTRS) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • Health-related Self-Care Efficacy as Assessed by The Self-Care Self-Efficacy Scale (SCSES) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • Trauma Coping Self-Efficacy as Assessed by Trauma Coping Self-Efficacy (CSE-T) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • General Self-Efficacy as Assessed by The General Self-Efficacy Scale-Short Form (GSE-6) [Time frame: Baseline (1st month), 3, 6 and 12 months]
  • Emotion Regulation as Assessed by The Emotion Regulation Questionnaire (ERQ) [Time frame: Baseline (1st month), 3, 6 and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Johns Hopkins University — Baltimore

Identifiers

NCT: NCT07227337 · IRB00504423 · 1R01MD018503-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗