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 range18 Years – 55 Years

SexFEMALE

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

What they're measuring

Change in depressive symptoms

Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

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)

Change in perceived stress

Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

Change in sexual risk behaviors

Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]

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)

Trial details

NCT IDNCT03664362

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-19

View on ClinicalTrials.gov More Violence trials

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in depressive symptoms

Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

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)

Change in perceived stress

Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

Change in sexual risk behaviors

Timeframe: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]

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)