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BSHAPE Intervention for PTSD and Depression in Immigrant Women

This study is testing an intervention called BSHAPE, which is designed to help foreign-born immigrant women who have experienced violence and are dealing with post-traumatic stress disorder (PTSD) and/or depression. BSHAPE will assess your experiences with violence, evaluate your safety needs, and offer ways to reduce trauma symptoms and promote health. The study will compare BSHAPE to a control group that receives general wellness information. Researchers will measure changes in your perceived stress, depression, and PTSD symptoms over 12 months to see if BSHAPE is effective. You may be able to join if you are an immigrant woman, age 18 or older, with a history of violence exposure and symptoms of PTSD or depression. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 676 women. Participants will be assigned to either the BSHAPE intervention or a control group receiving general wellness information.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your perceived stress, depression, and PTSD symptoms will be measured at baseline, 3 months, 6 months, and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227337

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

Recruiting
NAAges 18+InterventionalSupportive care
Johns Hopkins University
~676 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:BSHAPEControl (general wellness)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10)
Measured over Baseline (1st month), 3, 6 and 12 months
+5 more outcomes measured

Conditions

Post Traumatic Stress Disorder
Depression
Violence

Explore related trials

DepressionPost-Traumatic Stress Disorder

NCT07227337

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins University

    Baltimore, Marylandno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bushra Sabri · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Bushra Sabri
[email protected]
4109557105
Email the study team

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Eligibility criteria

Inclusion

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

Participants who don't meet the above criteria

What this trial measures

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

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

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

  • Self-Protection Behavior ChecklistBaseline (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.

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

  • Self-Care Behaviors as Assessed by The Mindful Self-Care Scale (MSCS) and The Behavioral Activation for Depression Scale-Short Form (BADS-SF)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.