Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders (ePerinatal-RCT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perinatal Depression; Perinatal Anxiety
• Intervention / Treatment: Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program; Other: Standard routine maternal care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Motrico, PhD Psychology; Phone Number: 0034636995778; Email: eperinatal@us.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program; 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.
Active Comparator: Control group	Other: Standard routine maternal care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of maternal perinatal depression and anxiety disorders	Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria	Baseline and 12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal depressive symptoms (mothers)	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)	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)	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)	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organizational readiness for implementing change	Organization's readiness for implementing changes in usual care. Assessment method: The Organizational Readiness Implementing Change (ORIC), a 12-item self-report measure. Each item is scored from 1 to 5, with higher scores indicating greater readiness for implementing change.	Measured before recruitment
PHC characteristics	Size of the population where the PHC is located and number of PHC professionals. Assessment method: Questionnaire developed by the research team	Measured before recruitment
App quality (mothers, partners)	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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: Yes: 10 points (the child is performing the skill); Sometimes: 5 points (the child is beginning to perform the skill or does it occasionally); Not Yet: 0 points (the child does not yet perform the skill)	6 months postpartum
Life quality (mothers, partners)	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)	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	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

Collaborators and Investigators

• Sponsor: University of Seville
• Collaborators: Health Service of Andalucia; Junta de Andalucia
• Investigators: Principal Investigator: Emma Motrico, PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Implementation; Anxiety; Prevention; mHealth; Perinatal
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Health Services Administration; Delivery of Health Care; Patient Care Management; Telemedicine
• Other Study ID Numbers: EP-WP3-2025; 101042139 (Other Identifier: European Research Council (ERC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No