Perinatal DepressionNCT06640907
Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
A study testing e-Perinatal personalized mHealth intervention integrated into routine maternal care and Standard routine maternal care with general perinatal health information 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 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perinatal Depression, Perinatal Anxiety
- What is being tested?
- e-Perinatal personalized mHealth intervention integrated into routine maternal care and Standard routine maternal care with general perinatal health information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
- 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
- There are no exclusion criteria for partners
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
Mairena del Aljarafe, Seville, 41927
About this study
Official title: Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)
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.
Read the detailed description
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.
- Conditions
- Perinatal Depression, Perinatal Anxiety
- Being tested
- e-Perinatal personalized mHealth intervention integrated into routine maternal care, Standard routine maternal care with general perinatal health information
- Keywords
- Depression, Anxiety, Perinatal, Well-being, Prevention, mHealth
- 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.
e-Perinatal personalized mHealth intervention integrated into routine maternal careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: e-Perinatal personalized mHealth intervention integrated into routine maternal care |
| Control group | Active comparator | Not described Receives: Other: Standard routine maternal care with general perinatal health information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: Measured at postintervention (2 months after baseline)
Secondary outcomes (9)
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.
Measured: Measured before recruitment
Fidelity
Measures adherence to the study protocol by PHC professionals. Assessment method: Surveys.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured at baseline, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 May 2025
- Primary completion11 Nov 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Andalusian Health Service, Junta de Andalucia
- Responsible party
- Principal investigator, Emma Motrico, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640907
- Sponsor's protocol ID
- SICEIA-2024-001659
- Other IDs
- 101042139
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosalba CC, Alessia C, Carlos BJ, Roberto CC, Paula DJ, Jose J GC, Lennert G, Francisco J NC, Amalia UL, Irene GG, Emma M. A personalized and complex mHealth intervention for the universal prevention of Perinatal mental Disorders in routine maternal Care: Design and development of e-Perinatal app. Int J Med Inform. 2026 May;211:106290. doi: 10.1016/j.ijmedinf.2026.106290. Epub 2026 Jan 31.
PubMed 41650699Nieto-Casado FJ, Gomez-Gomez I, Aznar-Lou I, Barquero-Jimenez C, Caceres I, Carretero S, Company-Cordoba R, De-Juan-Iglesias P, Dominguez-Salas S, Gil-Cosano JJ, Goossens L, Rodriguez-Dominguez C, Motrico E. A personalized mHealth intervention for the universal prevention of perinatal mental disorders in routine maternal care (e-Perinatal): A protocol study for a hybrid feasibility pilot trial. Open Res Eur. 2025 Jun 27;5:170. doi: 10.12688/openreseurope.20386.1. eCollection 2025.
PubMed 40904737
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 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): Pilot Randomized Control Trial (WP2)
- ClinicalTrials.gov ID
- NCT06640907
- Acronym / sponsor ID
- SICEIA-2024-001659
- Conditions
- Perinatal Depression, Perinatal Anxiety
- Keywords
- Depression, Anxiety, Perinatal, Well-being, Prevention, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Andalusian Health Service, Junta de Andalucia
- Study start
- 2 May 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 15 Oct 2024 (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 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.
Detailed description
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 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 controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
- 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 |
|---|---|---|
| e-Perinatal personalized mHealth intervention integrated into routine maternal careThe 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. | Behavioural | Intervention group |
| Standard routine maternal care with general perinatal health informationStandard 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. | Other | Control group |
Primary outcome
Feasibility of the intervention
Time frame: Measured at baseline and postintervention (2 months after baseline)
Calculation of participation rate, recruitment rate, and retention rate (follow-up rate) at all assessment points. Assessment method: Registration and follow-up records.
Early acceptability
Time frame: Measured at enrollment
Number of eligible women and partners who agree to participate. Assessment method: Consent forms.
Final acceptability
Time frame: Measured at postintervention (2 months after baseline)
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.
9 secondary outcomes
Adoption
Time frame: Measured before recruitment
Fidelity
Time frame: Measured at postintervention (2 months after baseline)
Early appropriateness
Time frame: Measured at enrollment
Final appropriateness
Time frame: Measured at postintervention (2 months after baseline)
Cumulative incidence of maternal perinatal depression and maternal perinatal anxiety
Time frame: Measured at enrollment and postintervention (2 months after baseline)
Depressive symptoms
Time frame: Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
Anxiety symptoms
Time frame: Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
Postnatal post-traumatic stress
Time frame: Measured at baseline
Well-being
Time frame: Measured at baseline, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 41650699Rosalba CC, Alessia C, Carlos BJ, Roberto CC, Paula DJ, Jose J GC, Lennert G, Francisco J NC, Amalia UL, Irene GG, Emma M. A personalized and complex mHealth intervention for the universal prevention of Perinatal mental Disorders in routine maternal Care: Design and development of e-Perinatal app. Int J Med Inform. 2026 May;211:106290. doi: 10.1016/j.ijmedinf.2026.106290. Epub 2026 Jan 31.
- Background: PubMed 40904737Nieto-Casado FJ, Gomez-Gomez I, Aznar-Lou I, Barquero-Jimenez C, Caceres I, Carretero S, Company-Cordoba R, De-Juan-Iglesias P, Dominguez-Salas S, Gil-Cosano JJ, Goossens L, Rodriguez-Dominguez C, Motrico E. A personalized mHealth intervention for the universal prevention of perinatal mental disorders in routine maternal care (e-Perinatal): A protocol study for a hybrid feasibility pilot trial. Open Res Eur. 2025 Jun 27;5:170. doi: 10.12688/openreseurope.20386.1. eCollection 2025.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Perinatal personalized mHealth intervention integrated into routine maternal care and Standard routine maternal care with general perinatal health information 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 11 inclusion and 3 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: finished, as of the sponsor's last update on 23 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: Measured at baseline and postintervention (2 months after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640907, which also lists 2 linked publications.
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 23 Sep 2026.