Perinatal DepressionePerinatal-RCTNCT07613008
Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders
A study testing The e-Perinatal intervention is a personalized mobile health (mHealth) program and Standard routine maternal care in people with Perinatal Depression and Perinatal Anxiety, run by University of Seville at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Perinatal Anxiety
- What is being tested?
- The e-Perinatal intervention is a personalized mobile health (mHealth) program and Standard routine maternal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
Mairena del Aljarafe, Sevilla, 41927
Ana Belén Naranjo Saucedo, MSc, +34 676426430, ana.naranjo@juntadeandalucia.es
About this study
Official title: Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial
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.
Read the detailed description
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.
- Conditions
- Perinatal Depression, Perinatal Anxiety
- Being tested
- The e-Perinatal intervention is a personalized mobile health (mHealth) program, Standard routine maternal care
- Keywords
- Depression, Anxiety, Perinatal, Prevention, mHealth, Implementation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The e-Perinatal intervention is a personalized mobile health (mHealth) programBehavioural
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.
Standard routine maternal careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: Standard routine maternal care |
| Intervention group | Experimental | Not described Receives: Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of maternal perinatal depression and anxiety disorders
Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria
Measured: Baseline and 12 months postpartum
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 Jul 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized hybrid type 1 effectiveness-implementation trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia, Andalusian Health Service
- Responsible party
- Principal investigator, Emma Motrico, University of Seville
- Investigators
- Emma Motrico, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613008
- Sponsor's protocol ID
- EP-WP3-2025
- Other IDs
- 101042139
- Acronym
- ePerinatal-RCT
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT07613008
- Acronym / sponsor ID
- ePerinatal-RCT / EP-WP3-2025
- Conditions
- Perinatal Depression, Perinatal Anxiety
- Keywords
- Depression, Anxiety, Perinatal, Prevention, mHealth, Implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Junta de Andalucia, Andalusian Health Service
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized hybrid type 1 effectiveness-implementation trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard routine maternal care |
| Intervention group | Experimental | Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The e-Perinatal intervention is a personalized mobile health (mHealth) programThe 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. | Behavioural | Intervention group |
| Standard routine maternal careParticipants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs. | Other | Control group |
Primary outcome
Cumulative incidence of maternal perinatal depression and anxiety disorders
Time frame: Baseline and 12 months postpartum
Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria
5 secondary outcomes
Maternal depressive symptoms (mothers)
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)
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)
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)
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)
Time frame: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Motrico, PhD principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The e-Perinatal intervention is a personalized mobile health (mHealth) program and Standard routine maternal care in people with Perinatal Depression and Perinatal Anxiety, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Motrico, PhD Psychology (0034636995778, eperinatal@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of maternal perinatal depression and anxiety disorders (time frame: Baseline and 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.