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

University of Seville96 enrolled

Overview

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.

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

Interventions

e-Perinatal personalized mHealth intervention integrated into routine maternal careBEHAVIORAL

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.

Standard routine maternal care with general perinatal health informationOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Measured at postintervention (2 months after baseline)

Secondary Outcomes

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.

Time frame: Measured before recruitment

Fidelity

Measures adherence to the study protocol by PHC professionals. Assessment method: Surveys.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Measured at baseline, postintervention (2 months after baseline), and follow-up (1 month after postintervention)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes