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

NCT06640907 | Recruiting

• 2 other identifiers: SICEIA-2024-001659101042139
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Perinatal Anxiety

Keywords

Depression; Anxiety; Perinatal; Well-being; Prevention; mHealth

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

Secondary Outcomes (9)

• Adoption

  Measured before recruitment

• Fidelity

  Measured at postintervention (2 months after baseline)

• Early appropriateness

  Measured at enrollment

• Final appropriateness

  Measured at postintervention (2 months after baseline)

• Cumulative incidence of maternal perinatal depression and maternal perinatal anxiety

  Measured at enrollment and postintervention (2 months after baseline)

Other Outcomes (24)

• Organizational readiness for implementing change

  Measured before recruitment

• App quality

  Measured at postintervention (2 months after baseline)

• Implementation process

  Measured at postintervention (2 months after baseline)

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: e-Perinatal personalized mHealth intervention integrated into routine maternal care

Control group

ACTIVE COMPARATOR

Other: Standard routine maternal care with general perinatal health information

Interventions

e-Perinatal personalized mHealth intervention integrated into routine maternal care 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.

Intervention group

Standard routine maternal care with general perinatal health information 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Seville: lead
• Health Service of Andalucia: collaborator
• Junta de Andalucia: collaborator

Study Sites (1)

Primary Health Care Center Mairena del Aljarafe - Ciudad Expo

Mairena del Aljarafe, Seville, 41927, Spain

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Francisco J. Nieto-Casado, PhD in Psychology

CONTACT

684785391; eperinatal@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will also be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow in Psychology

Model Details: Cluster-randomized hybrid type 1 controlled trial

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: May 2, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)