Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts will also be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility of the intervention
时间窗: 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
时间窗: Measured at enrollment
Number of eligible women and partners who agree to participate. Assessment method: Consent forms.
Final acceptability
时间窗: 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.
次要结局
- Adoption(Measured before recruitment)
- Fidelity(Measured at postintervention (2 months after baseline))
- Early appropriateness(Measured at enrollment)
- Final appropriateness(Measured at postintervention (2 months after baseline))
- Cumulative incidence of maternal perinatal depression and maternal perinatal anxiety(Measured at enrollment and postintervention (2 months after baseline))
- Depressive symptoms(Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention))
- Anxiety symptoms(Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention))
- Postnatal post-traumatic stress(Measured at baseline)
- Well-being(Measured at baseline, postintervention (2 months after baseline), and follow-up (1 month after postintervention))
研究者
Emma Motrico
Research Fellow in Psychology
University of Seville