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Идёт набор NCT07227337

Being Safe, Healthy, And Positively Empowered (BSHAPE) Intervention Study

Без фазы С лечением Post Traumatic Stress Disorder Depression Violence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: BSHAPE, Control (general wellness).
Кому может быть актуально
Состояния в реестре: Post Traumatic Stress Disorder, Depression, Violence. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Being Safe, Healthy, And Positively Empowered (BSHAPE): A Digital Multicomponent Intervention to Improve Health and Safety Outcomes Among Women With Cumulative Exposures to Violence

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое BSHAPE
    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.
  • Другое Control (general wellness)
    The control group will receive nutrition information and exercise guidance as well as a standard list of community resources.

Первичные конечные точки

  • Perceived Stress as Assessed by The Perceived Stress Scale-10 (PSS-10) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • Depression as Assessed by The Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • PTSD as Assessed by The PTSD Checklist-Civilian Version (PCL-C) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • Self-Protection Behavior Checklist [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • Empowerment for Safety as Assessed by The Adapted Measure of Victim Empowerment Related to Safety (MOVERS) [Срок оценки: 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) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
Вторичные конечные точки (7)
  • Safe Sex Behavior as Assessed by The Safe Sex Behavior Questionnaire (SSBQ) [Срок оценки: 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) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • Resilience as Assessed by The Brief Trauma Resiliency Scale (BTRS) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • Health-related Self-Care Efficacy as Assessed by The Self-Care Self-Efficacy Scale (SCSES) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • Trauma Coping Self-Efficacy as Assessed by Trauma Coping Self-Efficacy (CSE-T) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • General Self-Efficacy as Assessed by The General Self-Efficacy Scale-Short Form (GSE-6) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]
  • Emotion Regulation as Assessed by The Emotion Regulation Questionnaire (ERQ) [Срок оценки: Baseline (1st month), 3, 6 and 12 months]

Критерии участия

Критерии включения

  • age 18 or older
  • foreign-born immigrant woman
  • self-reported history of cumulative exposure to violence, and presence of PTSD and/or depression symptoms

Критерии исключения

  • Participants who don't meet the above criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Johns Hopkins University — Baltimore

Идентификаторы

NCT: NCT07227337 · IRB00504423 · 1R01MD018503-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗