Feasibility and Implementation of Early Referral in Perinatal Mental Health (e-Perinatal-Re)
Feasibility, Acceptability, and Preliminary Effectiveness of Early Referral Strategy to Specialized Mental Health Services: An Embedded Implementation Study
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Emma Motrico, PhD
- 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
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- None beyond those defined in the main trial
学习计划
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 |
|---|---|---|
|
Feasibility of referral strategy
大体时间：Baseline, 12 months postpartum
|
Assessment method: Recruitment rates, retention rates
|
Baseline, 12 months postpartum
|
|
Acceptability of the referral
大体时间：through study completion, an average of 18 months
|
Acceptability of referral will be assessed using an ad hoc self-report assessment.
|
through study completion, an average of 18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Identification of at-risk participants
大体时间：through study completion, an average of 18 months
|
Measure of the number of at-risk participants.
Participants will be considered at risk if they score above the clinical cutoff on at least one of the two scales (Edinburgh Postnatal Depression Scale (EPDS) ≥ 12 and/or Generalized Anxiety Disorder-7 (GAD-7) ≥ 10), measuring the severity of the depression and anxiety symptoms, respectively.
EPDS and GAD-7 will be collected within the e-Perinatal app.
|
through study completion, an average of 18 months
|
|
Referral to specialized mental health services
大体时间：through study completion, an average of 18 months
|
Number of referral to specialized mental health services, as recorded in clinical records.
|
through study completion, an average of 18 months
|
|
Time to referral
大体时间：through study completion, an average of 18 months
|
Assessment method: Time between identification and referral
|
through study completion, an average of 18 months
|
|
Engagement with mental health services
大体时间：through study completion, an average of 18 months
|
Number of accesses to specialized mental health services, as recorded in clinical records.
|
through study completion, an average of 18 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Follow-up period
大体时间：12 months
|
Assessment method: Semi-structured interviews (Normalization Process Theory)
|
12 months
|
|
Healthcare professional engagement
大体时间：12 months
|
Assessment method: semi-structured interviews
|
12 months
|
合作者和调查者
调查人员
- 首席研究员：Emma Motrico, PhD、University of Seville
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.