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

Stress Clinical Trial

— BSHAPE  

Official title:

Cumulative Victimization and Women's Health Risks: Development of an Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664362
• Other study ID #: IRB00101882
• Secondary ID: K99HD082350R00HD
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: February 19, 2022

Study information

• Verified date: May 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: February 19, 2022
• Est. primary completion date: February 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cumulative Trauma
• Empowerment
• HIV Risk
• Mental Health
• Reproductive Health
• Stress
• Violence
• Wounds and Injuries

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms	The Patient Health Questionnaire (PHQ-9) is a 9 item measure to assess depression symptoms based on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual (DSM-IV). Each of the 9 items scores from 0 (not at all) to 3 (nearly every day).	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Primary	Change in symptoms of post-traumatic stress disorder (PTSD)	Harvard Trauma Questionnaire (16 items) is used to measure symptoms of PTSD derived from the DSM-IIR/DSM-IV criteria for PTSD. The scale for each question includes four categories of response: "Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Primary	Change in perceived stress	The Perceived stress scale is a 10 item self-report measure of stress. It is designed to assess how stressed one feels in the past month. Item responses are rated on a 5-point scale ranging from 0 (Never) to 4 (Very often). Higher scores indicate higher perceived stress. This scale is scored by summing the answers to all items, for a highest score of 40. Scores 0-13 indicate low stress, 14-26 is moderate stress and 27-40 is considered high stress.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Primary	Change in sexual risk behaviors	The Safe Sex Behavior Questionnaire is a 27-item self-report measure that describes sexual behaviors such as condom usage, sexual communication, and high-risk sexual behaviors. Item responses are rated on a 4-point scale ranging from 1 (Never) to 4 (Always). There are no subscales, and all items are summed to create a total score. Higher scores indicate engagement in safer sexual behaviors	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
Primary	Change in empowerment related to safety as assessed by the MOVERS scale	The MOVERS is a 13 item scale that measures empowerment within the domain of safety. Participants respond to each item using a five-point scale from 1- "never true" to 5 - "always true". A maximum total of 65 and minimum of 13. Higher scores indicate higher level of empowerment related to safety.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary	Change in overall empowerment as assessed by the Personal Progress Scale-Revised	The Personal Progress Scale-Revised is a 28 item self-report measure of empowerment designed to assess multiple areas associated with empowerment such as positive self-evaluation, self-esteem, ability to regulate emotional distress, gender-role and cultural identity awareness, self-efficacy, self-care, problem-solving, assertiveness skills, and access to resources. Item responses are rated on a 7-point scale ranging from 1 (Almost Never) to 7 (Almost Always). A total maximum composite score of 196 and a minimum of 28. Higher scores indicate higher level of empowerment.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary	Change in self-efficacy related to coping with trauma as assessed by the Trauma Coping Self-Efficacy scale	The Trauma Coping Self-Efficacy scale is a 9-item self-report scale aimed at assessing the belief in one's ability to cope with trauma. Items are rated in a 7-point scale ranging from 1 (Not at all capable) to 7 (Totally capable). All items are averaged, for a high score of seven. Higher scores indicate greater trauma coping self-efficacy.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
Secondary	Change in self-efficacy for HIV/Sexually Transmitted Infection (STI) prevention as assessed by the Self-Efficacy for STI-HIV Scale	The Self-Efficacy for STI-HIV Scale measures an individual's perceived ability to practice STD and HIV prevention strategies. The measure consists of 10 self-report items which are rated on a 5-point scale ranging from 1 (Not Sure) to 5 (Completely sure). All items are summed for a total score that can range from 10-50 with higher scores indicating higher self-efficacy.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary	Change in HIV knowledge using the HIV Knowledge Questionnaire	The HIV Knowledge Questionnaire is a 18-item self report measure designed to measure ones understanding of HIV transmission and prevention. Items are scored in a true-false format where one point is awarded for a correct answer. Incorrect answers and "don't know" is scored as zero. Items are summed for a total possible score of 18. Higher scores indicate greater knowledge about how HIV is transmitted and how it can be prevented.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary	Change in Sexually Transmitted Disease (STD) knowledge using the STD Knowledge Questionnaire	The STD Knowledge Questionnaire is a 27-item self-report measure designed to assess knowledge of transmission and prevention of common STDs such as Gonorrhea, Chlamydia, Hepatitis B, Human Papilloma Virus (HPV), and Genital Warts. Items are scored on a true-false scale where one point is awarded for each correct response. No points are given for incorrect responses or "Don't know". Items are summed to create a highest possible score of 27, with higher scores indicating high knowledge of how to prevent and transmit STDs.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary	Change in attitudes for stress management as assessed by the Inventory of Positive Psychological Attitudes	The Inventory of Positive Psychological Attitudes measures attitudes in different domains that can act as buffers to prevent stress and stress-related disorders. The 15 items measuring confidence during stress is used which measures one's ability to handle difficult times will be used. Item responses are scored on a 7-point scale ranging from 1 to 7 with a maximum total of 105 and a minimum of 7. Higher scores indicate greater resiliency.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary	Change in utilization of healthcare services	The Health Care Utilization measure was adapted from the Women's Health Care Experiences Survey. This measure was created as a self-report measure to capture women's use of different health care related services such as physical checkups, HIV screening, family planning services, abortion services, and other healthcare needs. For each different category of service, the measure asks if the service was used, where the service was received, if the service is available and why it was not used (if applicable). Each service is treated as a separate question, providing unique data; no scores are summed or averaged.	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary	Change in severity and frequency of violence	The adapted version of the revised Conflict Tactics Scale (CTS) will be used to measure change in exposure to violence. The items on the CTS-2 are scored using the severity-times-frequency weighted score, as recommended by Straus (2004).	Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary	Change in physiological stress responses	Saliva samples are used to measure change in physiological stress response	Assessment time points, Baseline, 3 months and 6 months