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Идёт набор NCT07277816

Photo-experiencing and Reflective Listening (PEARL) to Promote Healing Engagement for Survivors of Violence

Без фазы С лечением Violence and Victimization

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: PEARL (Photo-experiencing and Reflective Listening).
Кому может быть актуально
Состояния в реестре: Violence and Victimization. Базовые параметры: от 18 лет · Все.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Photo-experiencing and Reflective Listening (PEARL) to Promote Healing Engagement for Survivors of Violence: A Feasibility Study

Обзор

The goal of this clinical trial is to learn if a photo-elicitation intervention called PEARL (Photo-experiencing and Reflective Listening) can promote healing engagement in survivors of interpersonal violence. It will also learn about the feasibility and acceptability of PEARL. The main questions it aims to answer are: Does PEARL reduce barriers to help-seeking for trauma? Does PEARL improve trauma coping self-efficacy? Does PEARL change post-trauma cognitions and readiness for recovery? Is PEARL feasible and acceptable to survivors of interpersonal violence? Researchers will compare people who receive PEARL immediately to people on a waitlist (who receive PEARL three months later) to see if PEARL improves healing engagement and help-seeking behaviors. Participants will: * Complete baseline surveys about their trauma history, mental health, healing, and help-seeking behaviors * Be randomly assigned to receive PEARL immediately or after a 3-month wait * Receive a photography-focusing prompt and create photos over two weeks (those in the immediate group or after the waiting period) * Participate in a reflective listening interview about their photos * Complete follow-up surveys immediately after the intervention and one month later * Participate in a one-month follow-up interview about their experience

Подробное описание

This is a randomized waitlist control feasibility study of the PEARL (Photo-experiencing and Reflective Listening) intervention for women survivors of interpersonal violence. The study will enroll 40 participants recruited through local community organizations, interpersonal violence email listservs, and social media platforms.

Randomization and Study Arms:

Interested participants will complete an online baseline questionnaire through Qualtrics and be randomly assigned (1:1) to either:

1. Immediate Intervention Group (n=20): Receives PEARL within two weeks of enrollment 2. Waitlist Control Group (n=20): Receives a resource referral list (standard of care) and completes PEARL three months later

Intervention Protocol:

The PEARL intervention consists of two components:

1. Participants receive a photography-focusing prompt and have two weeks to create photographs 2. Participants complete a reflective listening interview about their photographs

Assessment Schedule:

* Baseline: Demographics, trauma history, and outcome measures * Post-intervention: Outcome measures completed immediately after the intervention (trauma coping self-efficacy, post trauma cognitions, healing) * One-month follow-up: Outcome measures and qualitative interview (trauma coping self-efficacy, post trauma cognitions, healing, help-seeking actions, depression, anxiety, PTSD).

The waitlist control group completes an additional baseline survey three months after initial enrollment, which serves as their pre-intervention assessment.

Data Analysis: Feasibility will be assessed through completion rates, and research assistant evaluations. Acceptability will be evaluated through participant surveys and follow-up interviews. Preliminary impact on healing engagement and help-seeking will be analyzed using descriptive statistics and nonparametric tests. Qualitative data from open-ended survey questions, research assistant evaluations, and follow-up interviews will undergo thematic analysis. Quantitative and qualitative findings will be integrated to provide a comprehensive understanding of PEARL's feasibility, acceptability, and potential impact.

Community Engagement: The study incorporates feedback from Community Advisory Board (CAB) and Scientific Advisory Board (SAB) members throughout the research process. Purposive sampling strategies will be employed to achieve maximum diversity in participant age.

Вмешательства

  • Поведенческое PEARL (Photo-experiencing and Reflective Listening)
    PEARL is a two-component behavioral intervention designed to promote healing engagement among survivors of interpersonal violence. Participants receive a photography-focusing prompt and are given two weeks to create photographs that reflect their healing journey and experiences. After the two-week photography period, participants engage in a one-on-one reflective listening interview where they discuss the photographs they created and co-create a healing action plan based on these discussions. Th

Первичные конечные точки

  • Post-trauma Cognitions Inventory (PTCI) [Срок оценки: Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)]
  • Trauma Coping Self-efficacy Scale [Срок оценки: Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)]
  • Healing after Gender-based Violence Scale [Срок оценки: Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)]
Вторичные конечные точки (4)
  • PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)]
  • Patient Health Questionnaire-8 (PHQ-8) [Срок оценки: Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)]
  • Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)]
  • Trauma Recovery Actions Checklist (TRAC) [Срок оценки: Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)]

Критерии участия

Критерии включения

  • Age 18 years or older
  • History of interpersonal violence (IV) - identifies as a survivor of interpersonal violence
  • Able to complete an interview in English
  • Able to provide informed consent

Критерии исключения

  • Under 18 years of age
  • Does not identify as a woman (male participants excluded)
  • No history of interpersonal violence
  • Unable to complete an interview in English
  • Unable to provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Women in Transition — Philadelphia

Публикации

  • Sinko L, Saint Arnault D. Photo-experiencing and reflective listening: A trauma-informed photo-elicitation method to explore day-to-day health experiences. Public Health Nurs. 2021 Jul;38(4):661-670. doi: 10.1111/phn.12904. Epub 2021 Apr 4. PMID 33813744

Идентификаторы

NCT: NCT07277816 · 272926 · 5K01NR021275-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗