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

May 1, 2026 updated by: Johns Hopkins University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
676

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Arm
Participants will be randomized to the Control Arm
Other: Control (general wellness)
The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.
Experimental: BSHAPE intervention
Participants will be randomized to the BSHAPE intervention.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10)
Time Frame: Baseline (1st month), 3, 6 and 12 months
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)
Time Frame: Baseline (1st month), 3, 6 and 12 months
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)
Time Frame: Baseline (1st month), 3, 6 and 12 months
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
Time Frame: Baseline (1st month), 3, 6 and 12 months
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
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
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
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
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a 12-item self-report questionnaire that measures individual differences in mindfulness. Total scores range from 12 to 48, with higher scores indicating greater mindfulness abilities.
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
The Brief Trauma Resiliency Scale (BTRS) is a 28-item self-report questionnaire that measures trauma resilience, ability to "bounce back," after a traumatic experience. Total scores range from 28 to 140, with higher scores indicating greater trauma resilience.
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
The Self-Care Self-Efficacy Scale (SCSES) is a 10-item self-report questionnaire that measures individuals' confidence in their ability to engage in self-care behaviors across various health contexts. Total scores range from 10 to 50, with higher scores indicating greater confidence in performing self-care behaviors.
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
The Trauma Coping Self-Efficacy Scale is a 9-item self-report questionnaire that measures an individual's perceived confidence in their ability to cope with and recover from traumatic experiences. Total scores range from 9 to 63, with higher scores indicating greater confidence in one's ability to cope with trauma-related challenges and engage in recovery processes.
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
The General Self-Efficacy Scale-Short Form (GSE-6) is a 6-item self-report questionnaire. The scale assesses a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Total scores range from 6 to 24, with higher scores indicating greater general self-efficacy beliefs
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
The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report questionnaire that measures individual differences in emotion regulation strategies. Total scores range from 10 to 70, with higher scores indicating greater overall use of emotion regulation strategies.
Baseline (1st month), 3, 6 and 12 months
Safe Sex Behavior as Assessed by The Safe Sex Behavior Questionnaire (SSBQ)
Time Frame: Baseline (1st month), 3, 6 and 12 months
The Safe Sex Behavior Questionnaire (SSBQ) is a 24-item self-report questionnaire that measures sexual behaviors, condom usage, high risk sexual behaviors, and sexual communication and negotiation. Total scores range from 24 to 96, with higher scores indicating greater frequency of use of safe sex practices.
Baseline (1st month), 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bushra Sabri, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00504423
  • 1R01MD018503-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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