Feasibility and Implementation of Early Referral in Perinatal Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Seville
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None beyond those defined in the main trial
Trial design
Design model
Parallel
Treatments tested in this trial
The e-Perinatal intervention is a personalized mobile health (mHealth) program
BehavioralThe 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.
Standard routine maternal care
Other interventionParticipants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of referral strategy
Assessment method: Recruitment rates, retention rates
Time frame
Baseline, 12 months postpartum2
Acceptability of the referral
Acceptability of referral will be assessed using an ad hoc self-report assessment.
Time frame
through study completion, an average of 18 monthsSecondary outcomes
1
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.
Time frame
through study completion, an average of 18 months2
Referral to specialized mental health services
Number of referral to specialized mental health services, as recorded in clinical records.
Time frame
through study completion, an average of 18 months3
Time to referral
Assessment method: Time between identification and referral
Time frame
through study completion, an average of 18 months4
Engagement with mental health services
Number of accesses to specialized mental health services, as recorded in clinical records.
Time frame
through study completion, an average of 18 monthsOther outcomes
1
Follow-up period
Assessment method: Semi-structured interviews (Normalization Process Theory)
Time frame
12 months2
Healthcare professional engagement
Assessment method: semi-structured interviews
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Seville
Lead sponsor
Andalusian Health Service
Collaborator
Junta de Andalucia
Collaborator
Source ClinicalTrials.gov