Haalbaarheidsstudie en pilot hybride effectiviteitsimplementatiestudie voor de universele preventie van perinatale psychische stoornissen bij moeders als genormaliseerde routinepraktijk (e-Perinatale pilot)

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 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.

Calculation of participation rate, recruitment rate, and retention rate (follow-up rate) at all assessment points. Assessment method: Registration and follow-up records.

Number of eligible women and partners who agree to participate. Assessment method: Consent forms.

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.

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.

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

Number of eligible women and number of partners invited to participate by women. Assessment method: Consent forms and recruitment records.

Suitability and relevance of the intervention for the target population and context. Assessment method: Semi-structured interviews based on the Normalization Process Theory.

Measurement of the incidence of maternal perinatal depression and anxiety. Assessment method: The Mini International Neuropsychiatric Interview (MINI).

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.

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.

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.

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.

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.

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.

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.

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

Size of the population where the PHC is located and number of PHC professionals. Assessment method: Questionnaire developed by the research team

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.

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.

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.

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.

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.

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.

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.

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.

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.

Measures various developmental milestones in infants.

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.

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.

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.

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.

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.

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.

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.

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).

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.