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

NCT07227337 | Recruiting DMC

• 2 other identifiers: IRB005044231R01MD018503-01A1
• Study Type: interventional
• Target: 676
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Traumatic Stress Disorder; Depression; Violence

Keywords

Post Traumatic Stress Disorder (PTSD); Depression; Violence

Outcome Measures

Primary Outcomes (6)

• Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10)

  The Perceived Stress Scale-10 (PSS-10) is a 10-item questionnaire that measures the degree to which situations in one's life are appraised as stressful. Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.

  Baseline (1st month), 3, 6 and 12 months

• Depression as Assessed by The Patient Health Questionnaire-9 (PHQ-9)

  The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire that measures depression severity over the past 2 weeks. Total scores range from 0 to 27, with higher scores indicating more severe depression symptoms. Scores can be categorized as: minimal depression (0-4), mild depression (5-9), moderate depression (10-14), moderately severe depression (15-19), or severe depression (20-27).

  Baseline (1st month), 3, 6 and 12 months

• PTSD as Assessed by The PTSD Checklist-Civilian Version (PCL-C)

  The PTSD Checklist-Civilian Version (PCL-C) is a 17-item self-report questionnaire that measures provisional PTSD over the past month. Total scores range from 17 to 85, with higher scores indicating greater PTSD symptom severity.

  Baseline (1st month), 3, 6 and 12 months

• Self-Protection Behavior Checklist

  The Self-Protection Behavior Checklist is a 6-item self-report questionnaire that measures the frequency of self-protective strategies used by participants. Total scores range from 0 to 24, with higher scores is better, indicating more frequent use of self-protective strategies.

  Baseline (1st month), 3, 6 and 12 months

• Empowerment for Safety as Assessed by The Adapted Measure of Victim Empowerment Related to Safety (MOVERS)

  The Measure of Victim Empowerment Related to Safety (MOVERS) is a 13-item self-report questionnaire that measures survivor empowerment within the domain of safety. Total scores range from 13 to 65, with higher scores indicating greater empowerment for safety.

  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)

  The Self-Care Behaviors Scale is a 23-item self-report measure assessing engagement in self-care behaviors across multiple domains, including mindful relaxation, supportive relationships, supportive structure, general, and clinical areas. The scale combines items from the Mindful Self-Care Scale (MSCS) and the Behavioral Activation for Depression Scale-Short Form (BADS-SF) into a single composite measure. Total scores are calculated as the sum of all items and range from 0-92, with higher scores indicating greater engagement in self-care behaviors.

  Baseline (1st month), 3, 6 and 12 months

Secondary Outcomes (7)

• Safe Sex Behavior as Assessed by The Safe Sex Behavior Questionnaire (SSBQ)

  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)

  Baseline (1st month), 3, 6 and 12 months

• Resilience as Assessed by The Brief Trauma Resiliency Scale (BTRS)

  Baseline (1st month), 3, 6 and 12 months

• Health-related Self-Care Efficacy as Assessed by The Self-Care Self-Efficacy Scale (SCSES)

  Baseline (1st month), 3, 6 and 12 months

• Trauma Coping Self-Efficacy as Assessed by Trauma Coping Self-Efficacy (CSE-T)

  Baseline (1st month), 3, 6 and 12 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Participants will be randomized to the Control Arm

Other: Control (general wellness)

BSHAPE intervention

EXPERIMENTAL

Participants will be randomized to the BSHAPE intervention.

Behavioral: BSHAPE

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.

BSHAPE intervention

Control (general wellness) OTHER

The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• foreign-born immigrant woman
• self-reported history of cumulative exposure to violence, and presence of PTSD and/or depression symptoms

You may not qualify if:

• Participants who don't meet the above criteria

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Bushra Sabri

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bushra Sabri

CONTACT

4109557105; bsabri1@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 12, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)