Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
- Conditions
- Perinatal DepressionPerinatal Anxiety
- Registration Number
- NCT06640907
- Lead Sponsor
- University of Seville
- Brief 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).
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Feasibility of the intervention 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 Measured at enrollment Number of eligible women and partners who agree to participate. Assessment method: Consent forms.
Final acceptability 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.
- Secondary Outcome Measures
Name Time Method Adoption Measured before recruitment 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.
Fidelity Measured at postintervention (2 months after baseline) Measures adherence to the study protocol by PHC professionals. Assessment method: Surveys.
Early appropriateness Measured at enrollment Number of eligible women and number of partners invited to participate by women. Assessment method: Consent forms and recruitment records.
Final appropriateness Measured at postintervention (2 months after baseline) Suitability and relevance of the intervention for the target population and context. Assessment method: Semi-structured interviews based on the Normalization Process Theory.
Cumulative incidence of maternal perinatal depression and maternal perinatal anxiety Measured at enrollment and postintervention (2 months after baseline) Measurement of the incidence of maternal perinatal depression and anxiety. Assessment method: The Mini International Neuropsychiatric Interview (MINI).
Depressive symptoms Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention) 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.
Anxiety symptoms Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention) 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.
Postnatal post-traumatic stress Measured at baseline 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.
Well-being Measured at baseline, postintervention (2 months after baseline), and follow-up (1 month after postintervention) 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.
Trial Locations
- Locations (1)
Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
🇪🇸Mairena del Aljarafe, Seville, Spain