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| ID | Type | Description | Link |
|---|---|---|---|
| 101042139 | Other Grant/Funding Number | European Research Council (ERC) |
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| Name | Class |
|---|---|
| Andalusian Health Service | OTHER_GOV |
| Junta de Andalucia | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
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| Control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The e-Perinatal intervention is a personalized mobile health (mHealth) program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of referral strategy | Assessment method: Recruitment rates, retention rates | Baseline, 12 months postpartum |
| Acceptability of the referral | Acceptability of referral will be assessed using an ad hoc self-report assessment. | through study completion, an average of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of at-risk participants | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up period | Assessment method: Semi-structured interviews (Normalization Process Theory) | 12 months |
| Healthcare professional engagement | Assessment method: semi-structured interviews |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Motrico, PhD | Contact | 0034636995778 | eperinatal@us.es |
| Name | Affiliation | Role |
|---|---|---|
| Emma Motrico, PhD | University of Seville | Principal Investigator |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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Nesed in Cluster-randomized hybrid type 1 effectiveness-implementation trial
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Data analysts will also be masked.
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| Standard routine maternal care | Other | 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. |
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| through study completion, an average of 18 months |
| Referral to specialized mental health services | Number of referral to specialized mental health services, as recorded in clinical records. | through study completion, an average of 18 months |
| Time to referral | Assessment method: Time between identification and referral | through study completion, an average of 18 months |
| Engagement with mental health services | Number of accesses to specialized mental health services, as recorded in clinical records. | through study completion, an average of 18 months |
| 12 months |