Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
研究概览
简要总结
This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.
详细描述
This clinical trial evaluates the effectiveness and implementation of the e-Perinatal intervention, a personalized mobile health (mHealth) psychological program designed for the universal prevention of maternal perinatal depression and anxiety disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 effectiveness-implementation trial in routine maternal care settings within primary healthcare centers.
Primary healthcare centers will be randomized to either the intervention or control arm. Participants will include pregnant women and their partners.
The primary objective is to evaluate the effectiveness of the e-Perinatal intervention in reducing the cumulative incidence of maternal perinatal depression and anxiety disorders, assessed via structured diagnostic interviews. Secondary objectives include assessing maternal and paternal mental health outcomes, child development outcomes, and identifying moderators and mediators of intervention effectiveness.
In addition, the study will evaluate implementation outcomes, including acceptability, feasibility, adoption, fidelity, and barriers and facilitators to implementation in real-world healthcare settings.
Participants in the intervention group will receive access to the e-Perinatal app alongside usual maternal care. The e-Perinatal app 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. Participants in the control group will receive usual maternal care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts will also be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Inclusion Criteria (Women)
- •Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
- •Must be pregnant for at least 11 weeks 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
- •No diagnosis of depression or anxiety disorder at baseline Forma
- •- Inclusion Criteria (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
排除标准
- •Exclusion Criteria (Women)
- •Current diagnosis of depression or anxiety disorder
- •Receiving psychological or pharmacological treatment for mental health or substance use conditions
- •- Exclusion criteria for partners (or significant others):
- •There are no exclusion criteria for partners
研究组 & 干预措施
Control group
干预措施: Standard routine maternal care (Other)
Intervention group
干预措施: The e-Perinatal intervention is a personalized mobile health (mHealth) program (Behavioral)
研究者
Emma Motrico
Professor of Psychology
University of Seville