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Идёт набор NCT07011940

Walk With Me (WWM) for Perinatal Grief

Без фазы С лечением Grief Post Traumatic Stress Disorder Suicidal Ideation Miscarriage

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: Along With Me, Peer Guide.
Кому может быть актуально
Состояния в реестре: Grief, Post Traumatic Stress Disorder, Suicidal Ideation, Miscarriage. Базовые параметры: от 15 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
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Обзор

The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. It will also learn whether peer guides provide additional improvements on these outcomes. The main questions it aims to answer are: • Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention? Researchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation. Participants will: * Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms. * Receive check-ins with a Peer Guide (in the Peer Guide condition only)

Подробное описание

Our clinical trial is a randomized, three-group controlled trial in which 300 bereaved parents who have experienced pregnancy or early infant loss will be randomly assigned to control (Group 1: treatment as usual, n = 100), Along With Me only (Group 2, n = 100), or the Along With Me Plus Peer Guide (Group 3, n = 100). Participants will be recruited prior to randomization and assigned to condition after consent. Bereaved parents in the treatment arms will receive access to the Along With Me app that provides psychoeducation on grief, and Cognitive Behavioral Therapy (CBT) and Mindfulness skills to manage grief and reduce the risk of posttraumatic stress following pregnancy loss. All participants will complete a baseline assessment that includes self-report of posttraumatic stress symptoms and suicidal ideation, and secondary measures pertaining to mental health symptoms, substance use, coping, grief self-efficacy, and for those in the treatment condition, acceptability and usability for the Along With Me app. Additional assessments will occur at 3 months, 6 months, and 9 months.

Вмешательства

  • Поведенческое Along With Me
    Along With Me is a therapeutic app that delivers cognitive behavior therapy and mindfulness-based psychoeducation and skills, grief normalization, and exercises to address perinatal grief and to reduce trauma symptoms related to the experience of perinatal loss. The Along With Me only arm will deliver the app-based intervention only.
  • Поведенческое Peer Guide
    The peer guide will provide light touch reminders, opportunities to debrief, and resource navigation support, similar to community health navigator interventions provided remotely through insurers.

Первичные конечные точки

  • PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline, 3,6,9 months post-baseline]
  • Suicide Cognitions Scale (SCS-R) [Срок оценки: Baseline, 3,6,9 months post-baseline]
  • Columiba Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Baseline, 3, 6, and 9 moths post-baseline]
Вторичные конечные точки (4)
  • Generalized Anxiety Disorder 2-item scale (GAD-2) [Срок оценки: 3, 6, 9 months post-baseline]
  • Patient Health Questionnaire-2 (PHQ-2) [Срок оценки: 3,6,9 months post-baseline]
  • Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool [Срок оценки: 3,6,9 months post-baseline]
  • Perintal Grief Scale (PGS) [Срок оценки: Baseline, 3, 6, and 9 months post-baseline.]

Критерии участия

Критерии включения

  • Within the first month of pregnancy or early infant loss
  • Reside in the United State
  • Speak and read either English or Spanish at a 6th grade reading level
  • 15 or older

Критерии исключения

  • Not pregnant or has not experienced an early infant loss
  • Does not reside in the United State
  • Does not speak and read either English or Spanish at a 6th grade reading level
  • 14 or younger

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Oregon Research Behavioral Intervention Strategies, Inc. — Eugene
  • Oregon Research Behavioral Strategies, Inc. — Springfield

Идентификаторы

NCT: NCT07011940 · MH126788-02 · 2R44MH126788-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗