Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders (ePerinatal-RCT)
2026年7月15日 更新者：Emma Motrico、University of Seville
Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial
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.
研究概览
地位
招聘中
详细说明
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.
研究类型
介入性
注册 (估计的)
3000
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Emma Motrico, PhD Psychology
- 电话号码：0034636995778
- 邮箱：eperinatal@us.es
学习地点
-
-
Sevilla
-
Mairena del Aljarafe、Sevilla、西班牙、41927
- 招聘中
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
-
接触：
- Ana Belén Naranjo Saucedo, MSc
- 电话号码：+34 676426430
- 邮箱：ana.naranjo@juntadeandalucia.es
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：干预组
|
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 the app from recruitment (pregnancy) until 12 months of postpartum. |
|
有源比较器：控制组
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative incidence of maternal perinatal depression and anxiety disorders
大体时间：Baseline and 12 months postpartum
|
Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria
|
Baseline and 12 months postpartum
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maternal depressive symptoms (mothers)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
Changes in depressive symptoms.
Assessment method: The Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure.
Each item is scored from 0 to 3, with higher scores indicating more severe depressive symptoms.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
|
Maternal anxiety symptoms (mothers)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
Changes in anxiety symptoms.
Assessment method: The General Anxiety Questionnaire (GAD-7), a 7-item self-report measure.
Each item is scored from 0 to 3, with higher scores indicating more severe anxiety symptoms.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
|
Paternal depressive symptoms (partner)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
Changes in depressive symptoms.
Assessment method: The Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure.
Each item is scored from 0 to 3, with higher scores indicating more severe depressive symptoms.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
|
Paternal anxiety symptoms (partner)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
Changes in anxiety symptoms.
Assessment method: The General Anxiety Questionnaire (GAD-7), a 7-item self-report measure.
Each item is scored from 0 to 3, with higher scores indicating more severe anxiety symptoms.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
|
Psychological well-being (mothers, partners)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
Changes in subjective well-being.
Assessment method: The Well-Being Index (WHO-5), a 5-item self-report measure.
Each item is scored from 0 to 5, with higher scores indicating better subjective well-being.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
组织为实施变革做好准备
大体时间：入职前衡量
|
组织准备好实施常规护理变革。
评估方法：组织准备实施变革 (ORIC)，一项包含 12 项的自我报告措施。
每个项目的评分从 1 到 5，分数越高表明实施变革的准备程度越高。
|
入职前衡量
|
|
初级保健的特点
大体时间：入职前衡量
|
初级卫生保健机构所在地的人口规模和初级卫生保健专业人员的数量。
评估方法：研究小组制定的调查问卷
|
入职前衡量
|
|
App quality (mothers, partners)
大体时间：12 months postpartum
|
Objective and subjective quality, and the perceived impact of the application.
Assessment method: The User Version of the Mobile Application Rating Scale (u-MARS), a 26-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating better app quality.
|
12 months postpartum
|
|
Implementation process
大体时间：12 months postpartum
|
App implementation process from the perspective of healthcare professionals involved in implementing complex interventions.
Assessment method: The Normalization Measure Development Questionnaire (NoMAD), a 20-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating more effective implementation processes.
|
12 months postpartum
|
|
Barriers and facilitators
大体时间：12 months postpartum
|
Identifies barriers and facilitators impacting the integration of the intervention into routine healthcare, drawing from the experiences of users and healthcare professionals.
Assessment method: Semi-structured interviews following the Normalization Process Theory (NPT) framework
|
12 months postpartum
|
|
Reasons for dropout (mothers, partners)
大体时间：12 months postpartum
|
Number and reasons (e.g., experienced miscarriage or stillbirth, lack of engagement with the app) for dropout among women and their partners.
Assessment method: Records and semi structured interviews.
|
12 months postpartum
|
|
Antenatal and postnatal risks (mothers, partners)
大体时间：Baseline, 6 weeks postpartum
|
Measures both antenatal and postnatal risk factors.
Assessment method: The Antenatal Risk Questionnaire (ANRQ-R), a 11-item self-report measure.
Some items are scored from 1 to 5 and others are scored on categorical scale, with higher scores indicating greater risk.
|
Baseline, 6 weeks postpartum
|
|
Basic psychological needs (mothers, partners)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measures the satisfaction and frustration of basic psychological needs.
Assessment method: The Basic Psychological Need Satisfaction and Frustration Scale - Short Form (BPNSFS), a 12-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating a higher need satisfaction (i.e., need satisfaction subscale) or a higher need frustration (i.e., need frustration subscale).
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Maternal post-traumatic stress symptoms (mothers)
大体时间：6 weeks postpartum
|
Presence of post-traumatic stress symptoms after childbirth.
Assessment method: City Birth Trauma Scale (City-BiTS), a 5-item self-report measure.
A total of 4 items are scored from 0 to 3 and one item is scored from 0 to 1, with higher scores indicating greater severity of postnatal post-traumatic stress.
|
6 weeks postpartum
|
|
Maternal perceptions of childbirth (mothers)
大体时间：6 weeks postpartum
|
Measure of the perceived quality of the childbirth experience.
Assessment method: Childbirth Experience Questionnaire (CEQ-E), a 22-items self-report scale.
A total of 19 items range from 1 to 4. A total of 2 items range from 0 to 10. Higher scores indicate a more positive experience of childbirth.
|
6 weeks postpartum
|
|
Maternal breastfeeding experience (mothers)
大体时间：6 weeks postpartum; 6 months postpartum
|
Assessment method: Ad hoc instrument.
The instrument assesses infant feeding practices (2 items) and maternal satisfaction with breastfeeding (1 item), yielding a score ranging from 0 to 100.
Higher scores indicate greater satisfaction with breastfeeding.
|
6 weeks postpartum; 6 months postpartum
|
|
Maternal antenatal attachment (mothers)
大体时间：34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measures the level of maternal antenatal attachment to the baby.
Assessment method: The Maternal Antenatal Attachment Scale (MAAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger maternal antenatal attachment.
|
34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Paternal antenatal attachment (partners)
大体时间：34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measures the level of paternal antenatal attachment to the baby.
Assessment method: The Paternal Antenatal Attachment Scale (PAAS), a 16-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger paternal antenatal attachment.
|
34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Maternal postnatal attachment (mothers)
大体时间：6 weeks postpartum
|
Measures the level of maternal postnatal attachment to the baby.
Assessment method: The Maternal Postnatal Attachment Scale (MPAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger maternal postnatal attachment.
|
6 weeks postpartum
|
|
Paternal postnatal attachment (fathers)
大体时间：6 weeks postpartum
|
Measures the level of postnatal attachment to the baby in both mothers and fathers.
Assessment method: The Paternal Postnatal Attachment Scale (PPAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger paternal postnatal attachment.
|
6 weeks postpartum
|
|
Psychological flexibility (mothers, partner)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measure of psychological flexibility.
Assessment method: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT), a 10-item self-report scale.
Each item is scored from 1 to 7, with higher scores indicating greater psychological flexibilityTime
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Partnership quality (mothers, partners)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measures the quality of the marital or partnership relationship.
Assessment method: The Quality of Marriage Index (QMI), a 6-item self-report measure.
Some items are scored from 1 to 7 and others from 1 to 10, with higher scores indicating better relationship quality.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Parental role perception (mothers)
大体时间：6 months postpartum
|
Measures parents' perception of their competence in the parental role.
Assessment method: The Parental Sense of Competence scale (PSOC), a 21-item self-report measure.
Each item is scored from 1 to 6, with higher scores indicating a stronger sense of parental competence.
|
6 months postpartum
|
|
Coparenting dynamics (mothers, partners)
大体时间：6 months postpartum
|
Measures the dynamics of coparenting relationships.
Assessment method: The Coparenting Relationship Scale (CRS), a 14-item self-report measure.
Each item is scored from 0 to 6, with higher scores indicating more positive coparenting dynamics.
|
6 months postpartum
|
|
Mediterranean diet adherence (mothers, partners)
大体时间：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measure of adherence to the mediterranean diet.
Assessment method: Mediterranean Diet Adherence Screener (MEDAS), a 14-items self-report instrument.
Each item score from 0 to 1. Higher scores indicate greater adherence to the mediterranean diet.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Maternal physical activity levels (mothers)
大体时间：Baseline, 6 months postpartum
|
Measures physical activity levels in pregnant women and mothers.
Assessment method: The Pregnancy Physical Activity Questionnaire (PPAQ), a 33-item self-report measure.
Each item is scored from 0 to 5, with higher scores indicating higher levels of physical activity.
|
Baseline, 6 months postpartum
|
|
Physical condition (mothers)
大体时间：Baseline, 6 months postpartum
|
Measures overall physical condition and the main components (i.e., cardiorespiratory fitness, muscular strength, speed-agility, and flexibility) in pregnant women and mothers.
Assessment method: The International FItness Scale (IFIS), a 5-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating better physical condition.
|
Baseline, 6 months postpartum
|
|
Child temperament (mothers)
大体时间：6 months postpartum
|
Measures various aspect of infant temperament.
Assessment method: The Infant Behavior Questionnaire-Revised Short Form (IBQ-R SF), a 37-item self-report measure.
Each item is scored from 1 to 7, with higher scores indicating a higher frequency of the specified temperament behavior.
|
6 months postpartum
|
|
Child development (mothers)
大体时间：6 months postpartum
|
Measures of various domains of infant development. Assessment method: Ages & Stages Questionnaires (ASQ-3), a self-report measure. Each milestone question is answered using one of three frequency options, which are converted into point values:
|
6 months postpartum
|
|
Life quality (mothers, partners)
大体时间：12 months postpartum
|
Measures the overall quality of life.
Assessment method: The European Quality of Life-5 Dimensions-5 Levels (EuroQol-5D-5L), a 5-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating worse quality of life
|
12 months postpartum
|
|
Identity (mothers, partners)
大体时间：Baseline, 6 months postpartum
|
Measure of various domains of identity development.
Assessment method: Dimensions of Identity Development Scale (DIDS)., a 25-items self-report measure.
Each item is scored from 1 to 5, with higher scores indicating greater endorsement of the corresponding identity development dimension.
|
Baseline, 6 months postpartum
|
|
Economic data
大体时间：12 months postpartum
|
Measures healthcare service utilization and sick leave days over the previous year among participating women.
Assessment method: a post hoc semi-structured interview that collects information on emergency visits, hospital admissions, primary care visits (e.g., nurse, midwife, social worker), secondary care visits, and consultations with specialists.
|
12 months postpartum
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Emma Motrico, PhD、University of Seville
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月15日
初级完成 (估计的)
2027年12月30日
研究完成 (估计的)
2028年3月30日
研究注册日期
首次提交
2026年5月6日
首先提交符合 QC 标准的
2026年5月25日
首次发布 (实际的)
2026年5月29日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月15日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.