The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma (NCT03664362) | Clinical Trial Compass
CompletedNot Applicable
The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma
United States144 participantsStarted 2018-10-10
Plain-language summary
The goal of the BSHAPE study is to test a trauma informed, culturally tailored, multicomponent program entitled BSHAPE (Being Safe, Healthy, And Positively Empowered) for immigrant survivors of cumulative trauma.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-55 years of age
* Self-identify as a female
* Born in Africa or foreign born from African descent
* Must have a current or past abusive romantic relationship
* Must be a survivor of cumulative trauma
* Clinically significant symptoms of PTSD and/or depression
* At least one sexual HIV risk behavior
Exclusion Criteria:
* Less than 18 years of age or more than age 55
* Self-identify as a male
* Not African-born immigrant or born outside the US
* Is not a survivor of cumulative trauma
* Does not meet clinically significant criteria of PTSD and/or depression
* Does not report at least one sexual HIV risk behavior
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in depressive symptoms
Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
2
Change in symptoms of post-traumatic stress disorder (PTSD)
Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
3
Change in perceived stress
Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
4
Change in sexual risk behaviors
Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
5
Change in empowerment related to safety as assessed by the MOVERS scale
Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)