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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD018503-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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
Individuals with cumulative exposures to interpersonal violence are at high risk for co-occurring mental and physical health problems (e.g., PTSD, HIV/STI) and safety issues such as living in unsafe households or being in unsafe relationships. The proposed research will test the efficacy of Being Safe, Healthy, and Positively Empowered (BSHAPE), an intervention designed to comprehensively assess cumulative exposures to violence, current safety needs, and includes components to reduce the impact of trauma such as poor mental health, HIV/STI risk, and to promote health through knowledge building, skill building, and stress reduction practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Participants will be randomized to the Control Arm |
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| BSHAPE intervention | Experimental | Participants will be randomized to the BSHAPE intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BSHAPE | Behavioral | BSHAPE 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (1st month), 3, 6 and 12 months |
| 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). | Baseline (1st month), 3, 6 and 12 months |
| 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. | Baseline (1st month), 3, 6 and 12 months |
| 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. | Baseline (1st month), 3, 6 and 12 months |
| Empowerment for Safety as Assessed by The Adapted Measure of Victim Empowerment Related to Safety (MOVERS) | The Measure of Victim Empowerment Related to Safety (MOVERS) is a 13-item self-report questionnaire that measures survivor empowerment within the domain of safety. Total scores range from 13 to 65, with higher scores indicating greater empowerment for safety. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (1st month), 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bushra Sabri | Contact | 4109557105 | bsabri1@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bushra Sabri | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Control (general wellness) | Other | The control group will receive nutrition information and exercise guidance as well as a standard list of community resources. |
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| Baseline (1st month), 3, 6 and 12 months |
| Self-Care Behaviors as Assessed by The Mindful Self-Care Scale (MSCS) and The Behavioral Activation for Depression Scale-Short Form (BADS-SF) | The Self-Care Behaviors Scale is a 23-item self-report measure assessing engagement in self-care behaviors across multiple domains, including mindful relaxation, supportive relationships, supportive structure, general, and clinical areas. The scale combines items from the Mindful Self-Care Scale (MSCS) and the Behavioral Activation for Depression Scale-Short Form (BADS-SF) into a single composite measure. Total scores are calculated as the sum of all items and range from 0-92, with higher scores indicating greater engagement in self-care behaviors. | Baseline (1st month), 3, 6 and 12 months |
| 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. | Baseline (1st month), 3, 6 and 12 months |
| 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. | Baseline (1st month), 3, 6 and 12 months |
| 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. | Baseline (1st month), 3, 6 and 12 months |
| Trauma Coping Self-Efficacy as Assessed by Trauma Coping Self-Efficacy (CSE-T) | The Trauma Coping Self-Efficacy Scale is a 9-item self-report questionnaire that measures an individual's perceived confidence in their ability to cope with and recover from traumatic experiences. Total scores range from 9 to 63, with higher scores indicating greater confidence in one's ability to cope with trauma-related challenges and engage in recovery processes. | Baseline (1st month), 3, 6 and 12 months |
| General Self-Efficacy as Assessed by The General Self-Efficacy Scale-Short Form (GSE-6) | The General Self-Efficacy Scale-Short Form (GSE-6) is a 6-item self-report questionnaire. The scale assesses a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Total scores range from 6 to 24, with higher scores indicating greater general self-efficacy beliefs | Baseline (1st month), 3, 6 and 12 months |
| Emotion Regulation as Assessed by The Emotion Regulation Questionnaire (ERQ) | The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report questionnaire that measures individual differences in emotion regulation strategies. Total scores range from 10 to 70, with higher scores indicating greater overall use of emotion regulation strategies. | Baseline (1st month), 3, 6 and 12 months |
| D001519 | Behavior |