Being Safe, Healthy, And Positively Empowered (BSHAPE) Intervention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18 or older
foreign-born immigrant woman
self-reported history of cumulative exposure to violence, and presence of PTSD and/or depression symptoms
Disqualifiers
Participants who don't meet the above criteria
Trial design
Design model
Parallel
Treatments tested in this trial
BSHAPE
BehavioralBSHAPE 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 interventionThe control group will receive nutrition information and exercise guidance as well as a standard list of community resources.
Treatment groups
676 Participants
are divided into 2 treatment groupsGroup A: Control ArmActive comparator 1 intervention
Group B: BSHAPE interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (1st month), 3, 6 and 12 months2
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).
Time frame
Baseline (1st month), 3, 6 and 12 months3
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.
Time frame
Baseline (1st month), 3, 6 and 12 months4
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.
Time frame
Baseline (1st month), 3, 6 and 12 monthsSecondary outcomes
1
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.
Time frame
Baseline (1st month), 3, 6 and 12 months2
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.
Time frame
Baseline (1st month), 3, 6 and 12 months3
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.
Time frame
Baseline (1st month), 3, 6 and 12 months4
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.
Time frame
Baseline (1st month), 3, 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov