Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)

Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)

This study is part of the e-Perinatal project, funded by the European Research Council. This research project will follow the first three phases recommended by the Medical Research Council (MRC) framework for the development and evaluation of complex interventions (Skivington et al., 2021).

The primary aim is to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. Using a pilot, two-arm, cluster-randomized hybrid type 1 clinical trial, the study will assess key implementation outcomes and preliminary effectiveness indicators. The findings will inform the design of a future large clinical trial, intending to evaluate the effectiveness, cost-effectiveness, and implementation of the intervention as part of maternal care.

Study Overview

• Status: Recruiting
• Conditions: Perinatal Depression; Perinatal Anxiety
• Intervention / Treatment: Behavioral: e-Perinatal personalized mHealth intervention integrated into routine maternal care; Other: Standard routine maternal care with general perinatal health information

Detailed Description

This pilot clinical study investigates the feasibility, acceptability, and preliminary implementation and effectiveness of the e-Perinatal app, an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 trial within routine maternal care settings in primary healthcare centers in Andalusia, Spain. Participants will include pregnant and postpartum women (up to five months postpartum) and their partners. Primary healthcare centers will be randomized to either the intervention or control arm.

The primary objective is to evaluate the feasibility of integrating the e-Perinatal app into routine maternal care. Secondary objectives include assessing the acceptability of the intervention among women, partners, and healthcare professionals and exploring preliminary effectiveness outcomes, such as the incidence of perinatal depression and anxiety in women, changes in depressive and anxiety symptoms in both women and their partners, and potential impacts on infant health and development.

The study hypothesizes that the e-Perinatal intervention will be feasible and acceptable for pregnant and postpartum women, their partners, and healthcare professionals involved in routine maternal care.

Participants will be recruited from primary healthcare centres and allocated by cluster randomization to either the intervention group, which will receive the e-Perinatal app along with standard maternal care, or the control group, which will receive standard maternal care and monthly psychoeducational emails.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco J. Nieto-Casado, PhD in Psychology; Phone Number: +34 684785391; Email: eperinatal@us.es

Study Locations

• Spain
  • Seville
    • Mairena del Aljarafe, Seville, Spain, 41927
      • Recruiting
      • Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
      • Contact: Francisco J. Nieto-Casado, PhD in Psychology; Phone Number: +34 684785391; Email: fncasado@us.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria for mothers:

• Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
• Must be pregnant for at least 16 weeks or have given birth within the last 5 months 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

Inclusion criteria for 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 for mothers:

• Meet diagnostic criteria for anxiety or depression, as determined by a structured clinical interview
• Be on a waiting list or currently receiving psychological or pharmacological treatment for any mental health or substance use condition

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: e-Perinatal personalized mHealth intervention integrated into routine maternal care; The e-Perinatal intervention combines a personalized mobile health (mHealth) app with targeted training for healthcare professionals to support perinatal mental health within routine maternal care. Participants allocated to the intervention arm will use the app for a period of two months. The app offers psychoeducational content, video-guided physical activities, mindfulness exercises, mood-tracking tools, personalized recommendations through a rule-based algorithm, and social-community features. Healthcare professionals assigned to the intervention arm receive specialized training to integrate the app into their daily practice, enhancing their ability to promote and support mental health during the perinatal period.
Active Comparator: Control group	Other: Standard routine maternal care with general perinatal health information; Standard maternal care as routinely provided by the Andalusian public healthcare system (Spain). This includes scheduled visits with midwives, nurses, and pediatrician for maternal and infant health monitoring, as well as access to childbirth education programmes. Participants also receive monthly psychoeducational emails (two months) containing general information on perinatal mental health, pregnancy, and infant development. Healthcare professionals in this arm do not receive specialized training in perinatal mental health or in the use of digital interventions, and participants do not have access to the e-Perinatal app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early acceptability	Number of eligible women and partners who agree to participate. Assessment method: Consent forms.	Measured at enrollment
Final acceptability	Evaluation of how appropriate, satisfactory, and feasible the intervention is after its implementation. Assessment method: Surveys and semi-structured interviews based on the Normalization Process Theory.	Measured at postintervention (2 months after baseline)
Feasibility of the intervention	Calculation of participation rate, recruitment rate, and retention rate (follow-up rate) at all assessment points. Assessment method: Registration and follow-up records.	Measured at baseline and postintervention (2 months after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption	Proportion of Primary Health Care (PHC) professionals who express their willingness to participate in the study among the total of potential professionals prior to the start of the intervention. Assessment method: Registration records.	Measured before recruitment
Fidelity	Measures adherence to the study protocol by PHC professionals. Assessment method: Surveys.	Measured at postintervention (2 months after baseline)
Early appropriateness	Number of eligible women and number of partners invited to participate by women. Assessment method: Consent forms and recruitment records.	Measured at enrollment
Final appropriateness	Suitability and relevance of the intervention for the target population and context. Assessment method: Semi-structured interviews based on the Normalization Process Theory.	Measured at postintervention (2 months after baseline)
Cumulative incidence of maternal perinatal depression and maternal perinatal anxiety	Measurement of the incidence of maternal perinatal depression and anxiety. Assessment method: The Mini International Neuropsychiatric Interview (MINI).	Measured at enrollment and postintervention (2 months after baseline)
Depressive symptoms	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.	Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
Anxiety symptoms	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.	Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
Postnatal post-traumatic stress	Presence of post-traumatic stress symptoms and clinical disorder in women or their partners after childbirth. Assessment method: Assessed using City Birth Trauma Scale (City-BiTS), a 31-item self-report measure. Some items are scored from 0 to 3 and others from 0 to 2, with higher scores indicating greater severity of postnatal post-traumatic stress.	Measured at baseline
Well-being	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.	Measured at baseline, postintervention (2 months after baseline), and follow-up (1 month after postintervention)

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
App quality	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.	Measured at postintervention (2 months after baseline)
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.	Measured at postintervention (2 months after baseline)
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	Measured at postintervention (2 months after baseline)
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
Reasons for dropout	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.	Measured at postintervention (2 months after baseline)
Antenatal and postnatal risks	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.	Measured at baseline
Maternal antenatal attachment	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.	Measured at baseline
Paternal antenatal attachment	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.	Measured at baseline
Maternal postnatal attachment	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.	Measured at baseline
Paternal postnatal attachment	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.	Measured at baseline
Infant temperament	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.	Measured at baseline
Coparenting dynamics	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.	Measured at baseline
Parental role perception	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.	Measured at baseline
Infant development	Measures various developmental milestones in infants.	Measured at baseline
Partnership quality	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.	Measured at baseline
Sleep quality	Measures the quality of sleep among participants. Assessment method: The Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report measure. Some items are scored from 0 to 3 and some on a categorical scale, with higher scores indicating poorer sleep quality.	Measured at baseline
Life quality	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.	Measured at baseline
Maternal physical activity levels	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.	Measured at baseline
Paternal physical activity levels	Measures physical activity levels in fathers. Assessment method: The International Physical Activity Questionnaire (IPAQ), a 7-item self-report measure. Each item is scored on a categorical scale, with higher scores indicating higher levels of physical activity.	Measured at baseline
Physical condition	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.	Measured at baseline
Mood state	Measures positive and negative affect states. Assessment method: The Positive and Negative Affect Schedule (PANAS), a 20-item self-report measure. Each item is scored from 1 to 7, with higher scores indicating a higher frequency of the specified temperament behavior.	Measured at baseline
Basic psychological needs	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).	Measured at baseline
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.	Measured at postintervention (2 months after baseline)

Collaborators and Investigators

• Sponsor: University of Seville
• Collaborators: Health Service of Andalucia; Consejeria de Salud. Junta de Andalucia. Spain

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Prevention; mHealth; Well-being; Perinatal
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Psychotic Disorders; Depression; Mental Disorders
• Other Study ID Numbers: SICEIA-2024-001659; 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
• product manufactured in and exported from the U.S.: No