Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)

Официальное название

Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)

Обзор

This study is part of the e-Perinatal project, funded by the European Research Council. This research project will follow the first three phases recommended by the Medical Research Council (MRC) framework for the development and evaluation of complex interventions (Skivington et al., 2021). The primary aim is to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. Using a pilot, two-arm, cluster-randomized hybrid type 1 clinical trial, the study will assess key implementation outcomes and preliminary effectiveness indicators. The findings will inform the design of a future large clinical trial, intending to evaluate the effectiveness, cost-effectiveness, and implementation of the intervention as part of maternal care.

Подробное описание

This pilot clinical study investigates the feasibility, acceptability, and preliminary implementation and effectiveness of the e-Perinatal app, an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 trial within routine maternal care settings in primary healthcare centers in Andalusia, Spain. Participants will include pregnant and postpartum women (up to five months postpartum) and their partners. Primary healthcare centers will be randomized to either the intervention or control arm.

The primary objective is to evaluate the feasibility of integrating the e-Perinatal app into routine maternal care. Secondary objectives include assessing the acceptability of the intervention among women, partners, and healthcare professionals and exploring preliminary effectiveness outcomes, such as the incidence of perinatal depression and anxiety in women, changes in depressive and anxiety symptoms in both women and their partners, and potential impacts on infant health and development.

The study hypothesizes that the e-Perinatal intervention will be feasible and acceptable for pregnant and postpartum women, their partners, and healthcare professionals involved in routine maternal care.

Participants will be recruited from primary healthcare centres and allocated by cluster randomization to either the intervention group, which will receive the e-Perinatal app along with standard maternal care, or the control group, which will receive standard maternal care and monthly psychoeducational emails.

Вмешательства

• Поведенческое e-Perinatal personalized mHealth intervention integrated into routine maternal care
  The e-Perinatal intervention combines a personalized mobile health (mHealth) app with targeted training for healthcare professionals to support perinatal mental health within routine maternal care. Participants allocated to the intervention arm will use the app for a period of two months. The app offers psychoeducational content, video-guided physical activities, mindfulness exercises, mood-tracking tools, personalized recommendations through a rule-based algorithm, and social-community features
• Другое Standard routine maternal care with general perinatal health information
  Standard maternal care as routinely provided by the Andalusian public healthcare system (Spain). This includes scheduled visits with midwives, nurses, and pediatrician for maternal and infant health monitoring, as well as access to childbirth education programmes. Participants also receive monthly psychoeducational emails (two months) containing general information on perinatal mental health, pregnancy, and infant development. Healthcare professionals in this arm do not receive specialized train

Первичные конечные точки

• Feasibility of the intervention [Срок оценки: Measured at baseline and postintervention (2 months after baseline)]
• Early acceptability [Срок оценки: Measured at enrollment]
• Final acceptability [Срок оценки: Measured at postintervention (2 months after baseline)]

Вторичные конечные точки (9)

• Adoption [Срок оценки: Measured before recruitment]
• Fidelity [Срок оценки: Measured at postintervention (2 months after baseline)]
• Early appropriateness [Срок оценки: Measured at enrollment]
• Final appropriateness [Срок оценки: Measured at postintervention (2 months after baseline)]
• Cumulative incidence of maternal perinatal depression and maternal perinatal anxiety [Срок оценки: Measured at enrollment and postintervention (2 months after baseline)]
• Depressive symptoms [Срок оценки: Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention)]
• Anxiety symptoms [Срок оценки: Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention)]
• Postnatal post-traumatic stress [Срок оценки: Measured at baseline]
• Well-being [Срок оценки: Measured at baseline, postintervention (2 months after baseline), and follow-up (1 month after postintervention)]

Критерии участия

Inclusion criteria for mothers:

• Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
• Must be pregnant for at least 16 weeks or have given birth within the last 5 months at the time of enrollment
• Must be at least 18 years old
• Must have access to a mobile phone and internet connection
• Must be able to read, write, and understand Spanish
• Must have a personal email account

Inclusion criteria for partners (or significant others):

• Must receive an invitation to participate from a woman already enrolled in the study
• Must be at least 18 years old
• Must have access to a mobile phone and internet connection
• Must be able to read, write, and understand Spanish
• Must have a personal email account

Exclusion criteria for mothers:

• Meet diagnostic criteria for anxiety or depression, as determined by a structured clinical interview
• Be on a waiting list or currently receiving psychological or pharmacological treatment for any mental health or substance use condition

Exclusion criteria for partners (or significant others):

• There are no exclusion criteria for partners

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

Профилактика

Центры проведения

Испания · 1 центр

• Primary Health Care Center Mairena del Aljarafe - Ciudad Expo — Mairena del Aljarafe

Идентификаторы

NCT: NCT06640907 · SICEIA-2024-001659 · 101042139

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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