Perinatal Anxiety, Perinatal Depression
Conditions
Keywords
Depression, Anxiety, Perinatal, Referral, mHealth, Implementation
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
University of Seville
Andalusian Health Service
Junta de Andalucia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysts will also be masked.
Intervention model description
Nesed in Cluster-randomized hybrid type 1 effectiveness-implementation trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of referral strategy | Baseline, 12 months postpartum | Assessment method: Recruitment rates, retention rates |
| Acceptability of the referral | through study completion, an average of 18 months | Acceptability of referral will be assessed using an ad hoc self-report assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of at-risk participants | 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. |
| Referral to specialized mental health services | through study completion, an average of 18 months | Number of referral to specialized mental health services, as recorded in clinical records. |
| Time to referral | through study completion, an average of 18 months | Assessment method: Time between identification and referral |
| Engagement with mental health services | through study completion, an average of 18 months | Number of accesses to specialized mental health services, as recorded in clinical records. |
Countries
Spain
Contacts
CONTACTEmma Motrico, PhD
PRINCIPAL_INVESTIGATOREmma Motrico, PhD
University of Seville
Outcome results
None listed