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Идёт набор NCT07609550

Feasibility and Implementation of Early Referral in Perinatal Mental Health

Без фазы С лечением Perinatal Depression Perinatal Anxiety

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: The e-Perinatal intervention is a personalized mobile health (mHealth) program, Standard routine maternal care.
Кому может быть актуально
Состояния в реестре: Perinatal Depression, Perinatal Anxiety. 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
Испания
Следующий шаг
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Официальное название

Feasibility, Acceptability, and Preliminary Effectiveness of Early Referral Strategy to Specialized Mental Health Services: An Embedded Implementation Study

Обзор

This study is part of the e-Perinatal project and is embedded within the main cluster randomized trial. The primary aim is to evaluate the feasibility, acceptability, and preliminary effectiveness of an early diagnosis detection and referral strategy to specialized mental health services within routine maternal care. The secondary aim is to validate and implement an Artificial Intelligence-based algorithm for the early screening of mental health disorders in routine services.

Подробное описание

This embedded study evaluates the implementation of the e-Perinatal app as a screening tool to facilitate early referral to specialized mental health services within routine primary healthcare settings.

The study will be conducted within the context of the main e-Perinatal trial in primary healthcare centers in Andalusia, Spain. Participants will include pregnant and postpartum women enrolled in the main study who are at risk of presenting maternal perinatal depression and/or anxiety disorders, based on a structured clinical interview.

The primary objective is to assess the feasibility and acceptability of an early referral in routine care. The secondary aim is to validate and implement an Artificial Intelligence-based algorithm for the early screening of mental health disorders in routine services.

Data will be collected using questionnaires, clinical records, and semi-structured interviews with participants and healthcare professionals.

Вмешательства

  • Поведенческое The e-Perinatal intervention is a personalized mobile health (mHealth) program
    The e-Perinatal intervention is a personalized mobile health (mHealth) program that includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. The intervention is delivered through a mobile application and is integrated into routine maternal care. Participants will use
  • Другое Standard routine maternal care
    Participants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.

Первичные конечные точки

  • Feasibility of referral strategy [Срок оценки: Baseline, 12 months postpartum]
  • Acceptability of the referral [Срок оценки: through study completion, an average of 18 months]
Вторичные конечные точки (4)
  • Identification of at-risk participants [Срок оценки: through study completion, an average of 18 months]
  • Referral to specialized mental health services [Срок оценки: through study completion, an average of 18 months]
  • Time to referral [Срок оценки: through study completion, an average of 18 months]
  • Engagement with mental health services [Срок оценки: through study completion, an average of 18 months]

Критерии участия

Критерии включения

  • Pregnant and postpartum women enrolled in the main e-Perinatal trial, indicating the presence of a depressive or anxiety disorder with CIDI.
  • Access to smartphone and internet
  • Able to write and read in Spanish

Критерии исключения

  • None beyond those defined in the main trial

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Испания · 1 центр
  • Primary Health Care Center Mairena del Aljarafe - Ciudad Expo — Mairena del Aljarafe

Идентификаторы

NCT: NCT07609550 · EP-WP3-2025_R · 101042139

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗