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

NCT ID: NCT06640907

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2025-12-31

Brief Summary

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.

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.

Conditions

Perinatal Depression; Perinatal Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

e-Perinatal personalized mHealth intervention integrated into routine maternal care

Intervention Type: BEHAVIORAL

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.

Control group

Group Type: ACTIVE_COMPARATOR

Standard routine maternal care with general perinatal health information

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Service of Andalucia

OTHER_GOV

Sponsor Role: collaborator

Junta de Andalucia

OTHER_GOV

Sponsor Role: collaborator

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Emma Motrico

Research Fellow in Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Primary Health Care Center Mairena del Aljarafe - Ciudad Expo

Mairena del Aljarafe, Seville, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Francisco J. Nieto-Casado, PhD in Psychology

Role: CONTACT

eperinatal@us.es

684785391 ext. +34

Facility Contacts

Francisco J. Nieto-Casado, PhD in Psychology

Role: primary

fncasado@us.es

+34 684785391

Other Identifiers

101042139

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SICEIA-2024-001659

Identifier Type: -

Identifier Source: org_study_id