Post Traumatic Stress DisorderBSHAPENCT07227337
Being Safe, Healthy, And Positively Empowered (BSHAPE) Intervention Study
A study testing BSHAPE in people with Post Traumatic Stress Disorder and Depression, run by Johns Hopkins University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Traumatic Stress Disorder, Depression, Violence
- What is being tested?
- BSHAPE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 676 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older
- foreign-born immigrant woman
- self-reported history of cumulative exposure to violence, and presence of PTSD and/or depression symptoms
Who cannot join
- Participants who don't meet the above criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
About this study
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
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
Read the 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.
- Conditions
- Post Traumatic Stress Disorder, Depression, Violence
- Being tested
- BSHAPE, Control (general wellness)
- Keywords
- Post Traumatic Stress Disorder (PTSD), Depression, Violence
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSHAPEBehavioural
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)Other
The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Participants will be randomized to the Control Arm Receives: Other: Control (general wellness) |
| BSHAPE intervention | Experimental | Participants will be randomized to the BSHAPE intervention. Receives: Behavioral: BSHAPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (1st month), 3, 6 and 12 months
Secondary outcomes (7)
Safe Sex Behavior as Assessed by The Safe Sex Behavior Questionnaire (SSBQ)
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.
Measured: 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)
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.
Measured: Baseline (1st month), 3, 6 and 12 months
Resilience as Assessed by The Brief Trauma Resiliency Scale (BTRS)
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.
Measured: Baseline (1st month), 3, 6 and 12 months
Health-related Self-Care Efficacy as Assessed by The Self-Care Self-Efficacy Scale (SCSES)
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.
Measured: Baseline (1st month), 3, 6 and 12 months
Trauma Coping Self-Efficacy as Assessed by Trauma Coping Self-Efficacy (CSE-T)
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.
Measured: Baseline (1st month), 3, 6 and 12 months
General Self-Efficacy as Assessed by The General Self-Efficacy Scale-Short Form (GSE-6)
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
Measured: Baseline (1st month), 3, 6 and 12 months
Emotion Regulation as Assessed by The Emotion Regulation Questionnaire (ERQ)
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.
Measured: Baseline (1st month), 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start5 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 676 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Bushra Sabri, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227337
- Sponsor's protocol ID
- IRB00504423
- Other IDs
- 1R01MD018503-01A1
- Acronym
- BSHAPE
- Status last verified
- May 2026
- First submitted
- 10 Nov 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07227337
- Acronym / sponsor ID
- BSHAPE / IRB00504423
- Conditions
- Post Traumatic Stress Disorder, Depression, Violence
- Keywords
- Post Traumatic Stress Disorder (PTSD), Depression, Violence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 676 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Control (general wellness)Participants will be randomized to the Control Arm |
| BSHAPE intervention | Experimental | Behavioral: BSHAPEParticipants will be randomized to the BSHAPE intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 or older
- foreign-born immigrant woman
- self-reported history of cumulative exposure to violence, and presence of PTSD and/or depression symptoms
Key exclusion criteria (1 listed)
- Participants who don't meet the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSHAPEBSHAPE 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. | Behavioural | BSHAPE intervention |
| Control (general wellness)The control group will receive nutrition information and exercise guidance as well as a standard list of community resources. | Other | Control Arm |
Primary outcome
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.
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).
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.
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.
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.
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bushra Sabri principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BSHAPE in people with Post Traumatic Stress Disorder and Depression, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bushra Sabri (4109557105, bsabri1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.