Being Safe, Healthy, And Positively Empowered (BSHAPE): A Digital Multicomponent Intervention to Improve Health and Safety Outcomes Among Women With Cumulative Exposures to Violence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 676
- 试验地点
- 1
- 主要终点
- Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18 or older
- •foreign-born immigrant woman
- •self-reported history of cumulative exposure to violence, and presence of PTSD and/or depression symptoms
排除标准
- •Participants who don't meet the above criteria
研究组 & 干预措施
Control Arm
Participants will be randomized to the Control Arm
干预措施: Control (general wellness) (Other)
BSHAPE intervention
Participants will be randomized to the BSHAPE intervention.
干预措施: BSHAPE (Behavioral)
结局指标
主要结局
Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10)
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
Depression as Assessed by The Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline (1st month), 3, 6 and 12 months
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).
PTSD as Assessed by The PTSD Checklist-Civilian Version (PCL-C)
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
Self-Protection Behavior Checklist
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
Empowerment for Safety as Assessed by The Adapted Measure of Victim Empowerment Related to Safety (MOVERS)
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
Self-Care Behaviors as Assessed by The Mindful Self-Care Scale (MSCS) and The Behavioral Activation for Depression Scale-Short Form (BADS-SF)
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10)
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
Depression as Assessed by The Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline (1st month), 3, 6 and 12 months
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).
PTSD as Assessed by The PTSD Checklist-Civilian Version (PCL-C)
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
Self-Protection Behavior Checklist
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
Empowerment for Safety as Assessed by The Adapted Measure of Victim Empowerment Related to Safety (MOVERS)
时间窗: Baseline (1st month), 3, 6 and 12 months
The Measure of Victim Empowerment Related to Safety (MOVERS) is a 12-item self-report questionnaire that measures survivor empowerment within the domain of safety. Total scores range from 12 to 60, with higher scores indicating greater empowerment for safety.
Self-Care Behaviors as Assessed by The Mindful Self-Care Scale (MSCS) and The Behavioral Activation for Depression Scale-Short Form (BADS-SF)
时间窗: Baseline (1st month), 3, 6 and 12 months
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.
次要结局
- Safe Sex Behavior as Assessed by The Safe Sex Behavior Questionnaire (SSBQ)(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)(Baseline (1st month), 3, 6 and 12 months)
- Resilience as Assessed by The Brief Trauma Resiliency Scale (BTRS)(Baseline (1st month), 3, 6 and 12 months)
- Health-related Self-Care Efficacy as Assessed by The Self-Care Self-Efficacy Scale (SCSES)(Baseline (1st month), 3, 6 and 12 months)
- Trauma Coping Self-Efficacy as Assessed by Trauma Coping Self-Efficacy (CSE-T)(Baseline (1st month), 3, 6 and 12 months)
- General Self-Efficacy as Assessed by The General Self-Efficacy Scale-Short Form (GSE-6)(Baseline (1st month), 3, 6 and 12 months)
- Emotion Regulation as Assessed by The Emotion Regulation Questionnaire (ERQ)(Baseline (1st month), 3, 6 and 12 months)
- Safe Sex Behavior as Assessed by The Safe Sex Behavior Questionnaire (SSBQ)(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)(Baseline (1st month), 3, 6 and 12 months)
- Resilience as Assessed by The Brief Trauma Resiliency Scale (BTRS)(Baseline (1st month), 3, 6 and 12 months)
- Health-related Self-Care Efficacy as Assessed by The Self-Care Self-Efficacy Scale (SCSES)(Baseline (1st month), 3, 6 and 12 months)
- Trauma Coping Self-Efficacy as Assessed by Trauma Coping Self-Efficacy (CSE-T)(Baseline (1st month), 3, 6 and 12 months)
- General Self-Efficacy as Assessed by The General Self-Efficacy Scale-Short Form (GSE-6)(Baseline (1st month), 3, 6 and 12 months)
- Emotion Regulation as Assessed by The Emotion Regulation Questionnaire (ERQ)(Baseline (1st month), 3, 6 and 12 months)