An interventional study of e-Perinatal Butterfly and Standard routine maternal care in Depressive Symptoms, Perinatal Loss and Perinatal Grief, sponsored by University of Seville. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of Seville · Not applicable, Interventional, and Prevention
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
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.
8,247 studies on the registry are indexed under Depression; 1,645 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 6,873 interventional studies indexed under Depression.
Browse Depression studies →University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
Behavioral: e-Perinatal Butterfly
Other: Standard routine maternal care
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at postintervention (3 months after 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at enrolment and postintervention (3 months after enrollment)
App quality
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: Measured at postintervention (3 months after enrollment)
Basic psychological needs
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: Measured at enrollment and postintervention (3 months after enrollment)
Comparative Symptom Trajectories of Depression and Anxiety
Differences in mean change scores for depression and anxiety between bereaved mothers and partners using the Butterfly module and non-bereaved participants in the main e-Perinatal cohort. 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.
Time frame: Assessments aligned with primary study e-Perinatal: baseline, endpoints at 12 and 18 months post-Estimated Date of Delivery (EDD)
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 3,018 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 13 months is below that.
Counting every sponsor, half of 3,114 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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