Depressive Symptomse-ButterflyNCT07898176
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
A study testing e-Perinatal Butterfly and Standard routine maternal care in people with Depressive Symptoms and Perinatal Loss, run by University of Seville.
Trial summary
This study is part of the e-Perinatal project and is embedded within the parent e-Perinatal cluster randomized controlled trial (NCT07613008). No additional randomization is performed for this embedded study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Perinatal Loss, Perinatal Grief
- What is being tested?
- e-Perinatal Butterfly 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 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
- Woman enrolled in the parent e-Perinatal trial (NCT07613008) who experiences early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, during participation in the parent study; or
- Participating partner/ significant other of an eligible woman experiencing early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life.
Who cannot join
- None beyond those defined in the main trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility, Acceptability, and Preliminary Effects of e-Perinatal Butterfly, an Embedded Digital Intervention for Parents Experiencing Perinatal Loss
This study is part of the e-Perinatal project and is embedded within the parent e-Perinatal cluster randomized controlled trial (NCT07613008). No additional randomization is performed for this embedded study. Women participating in the parent trial who experience early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, together with their participating partners, are eligible for this study.
Participants retain the study-group allocation assigned to their primary healthcare center in the parent trial. Participants from clusters allocated to the intervention arm are offered access to the e-Perinatal Butterfly web-app as a complementary component of the e-Perinatal intervention. The e-Perinatal Butterfly web-app provides tailored psychoeducational resources and digital support tools for parents experiencing perinatal bereavement. Participants from clusters allocated to the control arm continue to receive usual care.
The primary objectives are to assess the feasibility and acceptability of the e-Perinatal Butterfly intervention. The study will also explore changes in symptoms of depression and anxiety among parents who have experienced a perinatal loss. Secondary exploratory analyses will examine longitudinal trajectories of depression and anxiety among bereaved participants and compare these trajectories between the intervention and control arms and with those observed in the broader cohort of the parent e-Perinatal trial
Read the detailed description
The e-Perinatal Butterfly intervention is a digital intervention specifically developed to provide psychological and psychoeducational support to women and their partners experiencing perinatal bereavement following pregnancy loss: early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life.
The e-Perinatal Butterfly intervention is a digital intervention specifically developed to provide psychological and psychoeducational support to women and their partners experiencing perinatal bereavement following early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life.
This study is embedded within the parent e-Perinatal cluster randomized controlled trial (NCT07613008), conducted in primary healthcare centers in Andalusia, Spain. In the parent trial, participating primary healthcare centers are randomized to either the e-Perinatal intervention or usual care. No additional randomization is conducted for the e-Perinatal Butterfly study. Participants retain the intervention allocation assigned to their primary healthcare center in the parent trial. Women enrolled in the parent e-Perinatal trial who experience early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, during study participation, together with their participating partners, are eligible for the embedded e-Perinatal Butterfly study. Participants from clusters allocated to the intervention arm continue to receive the e-Perinatal intervention and are additionally offered access to the e-Perinatal Butterfly web-app. The web-app includes tailored digital micro-interventions, psychoeducational resources, and support tools designed to address the specific needs of parents experiencing perinatal bereavement. Participants from clusters allocated to the control arm continue to receive usual care.
The primary objectives of this embedded study are to assess the feasibility and acceptability of the e-Perinatal Butterfly intervention. Exploratory analyses will examine changes in depressive and anxiety symptoms among participants experiencing perinatal bereavement. Secondary exploratory analyses will examine longitudinal trajectories of depressive and anxiety symptoms among bereaved participants and compare these trajectories between participants from the intervention and control arms of the parent trial. Additional exploratory analyses will compare these trajectories with those observed in the broader cohort of participants in the parent e-Perinatal trial.
Data will be collected through participant-reported questionnaires completed by women and their participating partners.
- Conditions
- Depressive Symptoms, Perinatal Loss, Perinatal Grief, Anxiety Symptoms
- Being tested
- e-Perinatal Butterfly, Standard routine maternal care
- Keywords
- pregnancy loss; stillbirth; neonatal death; perinatal bereavement; depression; anxiety; digital intervention; web-based intervention; eHealth
- Medical subject headings
- Depression, Anxiety Disorders, Stillbirth, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Perinatal ButterflyBehavioural
e-Perinatal Butterfly is a web-based digital intervention developed for parents experiencing perinatal bereavement. It provides tailored digital micro-interventions, psychoeducational resources, and support tools addressing psychological and emotional needs following early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life. The intervention is offered as a complementary component of the e-Perinatal intervention to eligible participants from clusters allocated to the intervention arm of the parent trial.
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 |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: e-Perinatal Butterfly |
| Control group | Active comparator | Not described Receives: Other: Standard routine maternal care |
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 enrollment and postintervention (3 months after enrollment)
Early acceptability
Number of eligible women and partners who agree to participate. Assessment method: Login to e-Perinatal Butterfly.
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 (3 months after enrollment)
Secondary outcomes (4)
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 (3 months after enrollment)
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 and postintervention (3 months after enrollment)
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 and postintervention (3 months after enrollment)
Perinatal grief
Measures the intensity and impact of grief following perinatal loss. Assessment method: The Perinatal Grief Scale, a 16-item self-report measure. Each item is scored from 1 to 5, with higher scores indicating a higher intensity and impact of grief on the psychological health.
Measured: Measured at enrolment and postintervention (3 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start2 Nov 2026 (estimated)
- 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 Depressive SymptomsStudies 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
- Nested in Cluster-randomized hybrid type 1 effectiveness-implementation trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT07898176
- Sponsor's protocol ID
- EP-WP3-2025_Loss
- Other IDs
- 101042139
- Acronym
- e-Butterfly
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Effects of e-Perinatal Butterfly, an Embedded Digital Intervention for Parents Experiencing Perinatal Loss
- ClinicalTrials.gov ID
- NCT07898176
- Acronym / sponsor ID
- e-Butterfly / EP-WP3-2025_Loss
- Conditions
- Depressive Symptoms, Perinatal Loss, Perinatal Grief, Anxiety Symptoms
- Keywords
- pregnancy loss; stillbirth; neonatal death; perinatal bereavement; depression; anxiety; digital intervention; web-based intervention; eHealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Andalusian Health Service
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 27 Oct 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 e-Perinatal project and is embedded within the parent e-Perinatal cluster randomized controlled trial (NCT07613008). No additional randomization is performed for this embedded study. Women participating in the parent trial who experience early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, together with their participating partners, are eligible for this study.
Participants retain the study-group allocation assigned to their primary healthcare center in the parent trial. Participants from clusters allocated to the intervention arm are offered access to the e-Perinatal Butterfly web-app as a complementary component of the e-Perinatal intervention. The e-Perinatal Butterfly web-app provides tailored psychoeducational resources and digital support tools for parents experiencing perinatal bereavement. Participants from clusters allocated to the control arm continue to receive usual care.
The primary objectives are to assess the feasibility and acceptability of the e-Perinatal Butterfly intervention. The study will also explore changes in symptoms of depression and anxiety among parents who have experienced a perinatal loss. Secondary exploratory analyses will examine longitudinal trajectories of depression and anxiety among bereaved participants and compare these trajectories between the intervention and control arms and with those observed in the broader cohort of the parent e-Perinatal trial
Detailed description
The e-Perinatal Butterfly intervention is a digital intervention specifically developed to provide psychological and psychoeducational support to women and their partners experiencing perinatal bereavement following pregnancy loss: early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life.
The e-Perinatal Butterfly intervention is a digital intervention specifically developed to provide psychological and psychoeducational support to women and their partners experiencing perinatal bereavement following early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life.
This study is embedded within the parent e-Perinatal cluster randomized controlled trial (NCT07613008), conducted in primary healthcare centers in Andalusia, Spain. In the parent trial, participating primary healthcare centers are randomized to either the e-Perinatal intervention or usual care. No additional randomization is conducted for the e-Perinatal Butterfly study. Participants retain the intervention allocation assigned to their primary healthcare center in the parent trial. Women enrolled in the parent e-Perinatal trial who experience early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, during study participation, together with their participating partners, are eligible for the embedded e-Perinatal Butterfly study. Participants from clusters allocated to the intervention arm continue to receive the e-Perinatal intervention and are additionally offered access to the e-Perinatal Butterfly web-app. The web-app includes tailored digital micro-interventions, psychoeducational resources, and support tools designed to address the specific needs of parents experiencing perinatal bereavement. Participants from clusters allocated to the control arm continue to receive usual care.
The primary objectives of this embedded study are to assess the feasibility and acceptability of the e-Perinatal Butterfly intervention. Exploratory analyses will examine changes in depressive and anxiety symptoms among participants experiencing perinatal bereavement. Secondary exploratory analyses will examine longitudinal trajectories of depressive and anxiety symptoms among bereaved participants and compare these trajectories between participants from the intervention and control arms of the parent trial. Additional exploratory analyses will compare these trajectories with those observed in the broader cohort of participants in the parent e-Perinatal trial.
Data will be collected through participant-reported questionnaires completed by women and their participating partners.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Nested in Cluster-randomized hybrid type 1 effectiveness-implementation trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: e-Perinatal Butterfly |
| Control group | Active comparator | Other: Standard routine maternal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Woman enrolled in the parent e-Perinatal trial (NCT07613008) who experiences early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, during participation in the parent study; or
- Participating partner/ significant other of an eligible woman experiencing early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life.
Key exclusion criteria (1 listed)
- None beyond those defined in the main trial
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 Butterflye-Perinatal Butterfly is a web-based digital intervention developed for parents experiencing perinatal bereavement. It provides tailored digital micro-interventions, psychoeducational resources, and support tools addressing psychological and emotional needs following early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life. The intervention is offered as a complementary component of the e-Perinatal intervention to eligible participants from clusters allocated to the intervention arm of the parent trial. | 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
Feasibility of the intervention
Time frame: Measured at enrollment and postintervention (3 months after enrollment)
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: Login to e-Perinatal Butterfly.
Final acceptability
Time frame: Measured at postintervention (3 months after enrollment)
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.
4 secondary outcomes
Final appropriateness
Time frame: Measured at postintervention (3 months after enrollment)
Depressive symptoms
Time frame: Measured at enrollment and postintervention (3 months after enrollment)
Anxiety symptoms
Time frame: Measured at enrollment and postintervention (3 months after enrollment)
Perinatal grief
Time frame: Measured at enrolment and postintervention (3 months after enrollment)
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 27 Oct 2026.
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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
Questions about this trial
What is this clinical trial studying?
A study testing e-Perinatal Butterfly and Standard routine maternal care in people with Depressive Symptoms and Perinatal Loss, run by University of Seville.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (0034636995778, eperinatal@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: Measured at enrollment and postintervention (3 months after enrollment)). 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?
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 27 Oct 2026.