An interventional study of The e-Perinatal intervention is a personalized mobile health (mHealth) program and Standard routine maternal care in Perinatal Depression and Perinatal Anxiety, sponsored by University of Seville. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of Seville · Not applicable, Interventional, and Prevention
This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.
This clinical trial evaluates the effectiveness and implementation of the e-Perinatal intervention, a personalized mobile health (mHealth) psychological program designed for the universal prevention of maternal perinatal depression and anxiety disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 effectiveness-implementation trial in routine maternal care settings within primary healthcare centers.
Primary healthcare centers will be randomized to either the intervention or control arm. Participants will include pregnant women and their partners.
The primary objective is to evaluate the effectiveness of the e-Perinatal intervention in reducing the cumulative incidence of maternal perinatal depression and anxiety disorders, assessed via structured diagnostic interviews. Secondary objectives include assessing maternal and paternal mental health outcomes, child development outcomes, and identifying moderators and mediators of intervention effectiveness.
In addition, the study will evaluate implementation outcomes, including acceptability, feasibility, adoption, fidelity, and barriers and facilitators to implementation in real-world healthcare settings.
Participants in the intervention group will receive access to the e-Perinatal app alongside usual maternal care. The e-Perinatal app includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. Participants in the control group will receive usual maternal care.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 81 across 7,063 interventional studies indexed under Depression.
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Inclusion Criteria:
- Inclusion Criteria (Women)
Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
Must be pregnant for at least 11 weeks 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
No diagnosis of depression or anxiety disorder at baseline Forma
- Inclusion Criteria (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:
Current diagnosis of depression or anxiety disorder
Receiving psychological or pharmacological treatment for mental health or substance use conditions
- Exclusion criteria for partners (or significant others):
There are no exclusion criteria for partners
Other: Standard routine maternal care
Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program
The e-Perinatal intervention is a personalized mobile health (mHealth) program that includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. The intervention is delivered through a mobile application and is integrated into routine maternal care. Participants will use the app from recruitment (pregnancy) until 12 months of postpartum.
Participants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.
Cumulative incidence of maternal perinatal depression and anxiety disorders
Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria
Time frame: Baseline and 12 months postpartum
Maternal depressive symptoms (mothers)
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: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
Maternal anxiety symptoms (mothers)
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: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
Paternal depressive symptoms (partner)
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: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
Paternal anxiety symptoms (partner)
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: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
Psychological well-being (mothers, partners)
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: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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.
Time frame: Measured before recruitment
App quality (mothers, partners)
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.
Time frame: 12 months postpartum
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.
Time frame: 12 months postpartum
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
Time frame: 12 months postpartum
PHC characteristics
Size of the population where the PHC is located and number of PHC professionals. Assessment method: Questionnaire developed by the research team
Time frame: Measured before recruitment
Reasons for dropout (mothers, partners)
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.
Time frame: 12 months postpartum
Antenatal and postnatal risks (mothers, partners)
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.
Time frame: Baseline, 6 weeks postpartum
Basic psychological needs (mothers, partners)
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).
Time frame: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
Maternal post-traumatic stress symptoms (mothers)
Presence of post-traumatic stress symptoms after childbirth. Assessment method: City Birth Trauma Scale (City-BiTS), a 5-item self-report measure. A total of 4 items are scored from 0 to 3 and one item is scored from 0 to 1, with higher scores indicating greater severity of postnatal post-traumatic stress.
Time frame: 6 weeks postpartum
Maternal perceptions of childbirth (mothers)
Measure of the perceived quality of the childbirth experience. Assessment method: Childbirth Experience Questionnaire (CEQ-E), a 22-items self-report scale. A total of 19 items range from 1 to 4. A total of 2 items range from 0 to 10. Higher scores indicate a more positive experience of childbirth.
Time frame: 6 weeks postpartum
Maternal breastfeeding experience (mothers)
Assessment method: Ad hoc instrument. The instrument assesses infant feeding practices (2 items) and maternal satisfaction with breastfeeding (1 item), yielding a score ranging from 0 to 100. Higher scores indicate greater satisfaction with breastfeeding.
Time frame: 6 weeks postpartum; 6 months postpartum
Maternal antenatal attachment (mothers)
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.
Time frame: 34-36 weeks of gestation (for participants enrolled before 31 weeks)
Paternal antenatal attachment (partners)
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.
Time frame: 34-36 weeks of gestation (for participants enrolled before 31 weeks)
Maternal postnatal attachment (mothers)
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.
Time frame: 6 weeks postpartum
Paternal postnatal attachment (fathers)
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.
Time frame: 6 weeks postpartum
Psychological flexibility (mothers, partner)
Measure of psychological flexibility. Assessment method: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT), a 10-item self-report scale. Each item is scored from 1 to 7, with higher scores indicating greater psychological flexibilityTime
Time frame: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
Partnership quality (mothers, partners)
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.
Time frame: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
Parental role perception (mothers)
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.
Time frame: 6 months postpartum
Coparenting dynamics (mothers, partners)
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.
Time frame: 6 months postpartum
Mediterranean diet adherence (mothers, partners)
Measure of adherence to the mediterranean diet. Assessment method: Mediterranean Diet Adherence Screener (MEDAS), a 14-items self-report instrument. Each item score from 0 to 1. Higher scores indicate greater adherence to the mediterranean diet.
Time frame: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
Maternal physical activity levels (mothers)
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.
Time frame: Baseline, 6 months postpartum
Physical condition (mothers)
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.
Time frame: Baseline, 6 months postpartum
Child temperament (mothers)
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.
Time frame: 6 months postpartum
Child development (mothers)
Measures of various domains of infant development. Assessment method: Ages \& Stages Questionnaires (ASQ-3), a self-report measure. Each milestone question is answered using one of three frequency options, which are converted into point values: * Yes: 10 points (the child is performing the skill) * Sometimes: 5 points (the child is beginning to perform the skill or does it occasionally) * Not Yet: 0 points (the child does not yet perform the skill)
Time frame: 6 months postpartum
Life quality (mothers, partners)
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
Time frame: 12 months postpartum
Identity (mothers, partners)
Measure of various domains of identity development. Assessment method: Dimensions of Identity Development Scale (DIDS)., a 25-items self-report measure. Each item is scored from 1 to 5, with higher scores indicating greater endorsement of the corresponding identity development dimension.
Time frame: Baseline, 6 months postpartum
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.
Time frame: 12 months postpartum
Plan to share: No
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