Recruiting

Digital Intervention

Sponsor:

Johns Hopkins University

Code:

NCT07227337

Conditions

Post Traumatic Stress Disorder

Depression

Violence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BSHAPE

Control (general wellness)

Study Details

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

Study ID

NCT07227337

Start date

Nov 5, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

676 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Control Arm

Participants will be randomized to the Control Arm

experimental: BSHAPE intervention

Participants will be randomized to the BSHAPE intervention.

Interventions

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.

Control (general wellness)

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

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Bushra Sabri

4109557105bsabri1@jhu.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

More Information

Sponsor

Johns Hopkins University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Post Traumatic Stress Disorder (PTSD)
  • Depression
  • Violence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-06.