The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2022-02-19

Brief Summary

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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.

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Detailed Description

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The central hypothesis is that the BSHAPE intervention will promote immigrant women's safety and health (e.g..,improved mental health, reduced physiological impact of stress and health inequities (especially reproductive-sexual health and HIV)), thus leading to overall empowerment.

The study will:

1. Conduct a feasibility and acceptability evaluation of the BSHAPE intervention.
2. Test the BSHAPE intervention for large scale implementation in community-based clinics and programs serving immigrant women.

The impact of BSHAPE will be evaluated in comparison to usual care in promoting safety and health outcomes among immigrant women with cumulative trauma experiences at post-intervention and at 6 and 12 months follow up.

Conditions

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Violence Cumulative Trauma HIV Risk Stress Mental Health Reproductive Health Empowerment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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The BSHAPE Intervention

Participants in the BSHAPE intervention attend a 9 sessions program post-assessments which is a combination of individualized and group-based sessions.

Group Type EXPERIMENTAL

The BSHAPE Intervention

Intervention Type BEHAVIORAL

The BSHAPE intervention program key elements include strengths based assessments, individualized plans and support based on priorities and needs, motivational interviewing strategies, psychoeducation (education with skill building exercises), mindfulness activities, danger assessment, safety planning, behavioral activation and linkage to community resources

Usual care or no treatment control

Participants in the control arm either are receiving no services or are engaged in usual care provided by community-based/health care organizations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The BSHAPE Intervention

The BSHAPE intervention program key elements include strengths based assessments, individualized plans and support based on priorities and needs, motivational interviewing strategies, psychoeducation (education with skill building exercises), mindfulness activities, danger assessment, safety planning, behavioral activation and linkage to community resources

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes