Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders (ePerinatal-RCT)
2026年5月25日 更新者：Emma Motrico、University of Seville
Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial
This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial.
The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders.
Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.
調査の概要
状態
まだ募集していません
詳細な説明
This clinical trial evaluates the effectiveness and implementation of the e-Perinatal intervention, a personalized mobile health (mHealth) psychological program designed for the universal prevention of maternal perinatal depression and anxiety disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 effectiveness-implementation trial in routine maternal care settings within primary healthcare centers.
Primary healthcare centers will be randomized to either the intervention or control arm. Participants will include pregnant women and their partners.
The primary objective is to evaluate the effectiveness of the e-Perinatal intervention in reducing the cumulative incidence of maternal perinatal depression and anxiety disorders, assessed via structured diagnostic interviews. Secondary objectives include assessing maternal and paternal mental health outcomes, child development outcomes, and identifying moderators and mediators of intervention effectiveness.
In addition, the study will evaluate implementation outcomes, including acceptability, feasibility, adoption, fidelity, and barriers and facilitators to implementation in real-world healthcare settings.
Participants in the intervention group will receive access to the e-Perinatal app alongside usual maternal care. The e-Perinatal app includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. Participants in the control group will receive usual maternal care.
研究の種類
介入
入学 (推定)
3000
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Emma Motrico, PhD Psychology
- 電話番号：0034636995778
- メール：eperinatal@us.es
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Inclusion Criteria (Women)
Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
Must be pregnant for at least 11 weeks 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
No diagnosis of depression or anxiety disorder at baseline Forma
- Inclusion Criteria (Partners or significant others)
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
Exclusion Criteria:
- Exclusion Criteria (Women)
Current diagnosis of depression or anxiety disorder
Receiving psychological or pharmacological treatment for mental health or substance use conditions
- Exclusion criteria for partners (or significant others):
There are no exclusion criteria for partners
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：介入群
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The e-Perinatal intervention is a personalized mobile health (mHealth) program that includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. The intervention is delivered through a mobile application and is integrated into routine maternal care. Participants will use the app from recruitment (pregnancy) until 12 months of postpartum. |
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アクティブコンパレータ：対照群
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cumulative incidence of maternal perinatal depression and anxiety disorders
時間枠：Baseline and 12 months postpartum
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Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria
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Baseline and 12 months postpartum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maternal depressive symptoms (mothers)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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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.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Maternal anxiety symptoms (mothers)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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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.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Paternal depressive symptoms (partner)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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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.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Paternal anxiety symptoms (partner)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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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.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Psychological well-being (mothers, partners)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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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.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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変化を実現するための組織の準備
時間枠：採用前に測定
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通常のケアの変更を導入するための組織の準備。
評価方法: Organizational Readiness Implementing Change (ORIC)、12 項目の自己報告尺度。
各項目には 1 から 5 のスコアが付けられ、スコアが高いほど、変更を実装する準備が整っていることを示します。
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採用前に測定
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PHCの特性
時間枠：採用前に測定
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PHC が所在する人口の規模と PHC 専門家の数。
評価方法：研究チームが作成したアンケート
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採用前に測定
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App quality (mothers, partners)
時間枠：12 months postpartum
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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.
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12 months postpartum
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Implementation process
時間枠：12 months postpartum
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App implementation process from the perspective of healthcare professionals involved in implementing complex interventions.
Assessment method: The Normalization Measure Development Questionnaire (NoMAD), a 20-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating more effective implementation processes.
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12 months postpartum
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Barriers and facilitators
時間枠：12 months postpartum
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Identifies barriers and facilitators impacting the integration of the intervention into routine healthcare, drawing from the experiences of users and healthcare professionals.
Assessment method: Semi-structured interviews following the Normalization Process Theory (NPT) framework
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12 months postpartum
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Reasons for dropout (mothers, partners)
時間枠：12 months postpartum
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Number and reasons (e.g., experienced miscarriage or stillbirth, lack of engagement with the app) for dropout among women and their partners.
Assessment method: Records and semi structured interviews.
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12 months postpartum
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Antenatal and postnatal risks (mothers, partners)
時間枠：Baseline, 6 weeks postpartum
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Measures both antenatal and postnatal risk factors.
Assessment method: The Antenatal Risk Questionnaire (ANRQ-R), a 11-item self-report measure.
Some items are scored from 1 to 5 and others are scored on categorical scale, with higher scores indicating greater risk.
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Baseline, 6 weeks postpartum
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Basic psychological needs (mothers, partners)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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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).
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Maternal post-traumatic stress symptoms (mothers)
時間枠：6 weeks postpartum
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Presence of post-traumatic stress symptoms after childbirth.
Assessment method: City Birth Trauma Scale (City-BiTS), a 5-item self-report measure.
A total of 4 items are scored from 0 to 3 and one item is scored from 0 to 1, with higher scores indicating greater severity of postnatal post-traumatic stress.
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6 weeks postpartum
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Maternal perceptions of childbirth (mothers)
時間枠：6 weeks postpartum
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Measure of the perceived quality of the childbirth experience.
Assessment method: Childbirth Experience Questionnaire (CEQ-E), a 22-items self-report scale.
A total of 19 items range from 1 to 4. A total of 2 items range from 0 to 10. Higher scores indicate a more positive experience of childbirth.
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6 weeks postpartum
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Maternal breastfeeding experience (mothers)
時間枠：6 weeks postpartum; 6 months postpartum
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Assessment method: Ad hoc instrument.
The instrument assesses infant feeding practices (2 items) and maternal satisfaction with breastfeeding (1 item), yielding a score ranging from 0 to 100.
Higher scores indicate greater satisfaction with breastfeeding.
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6 weeks postpartum; 6 months postpartum
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Maternal antenatal attachment (mothers)
時間枠：34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measures the level of maternal antenatal attachment to the baby.
Assessment method: The Maternal Antenatal Attachment Scale (MAAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger maternal antenatal attachment.
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34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Paternal antenatal attachment (partners)
時間枠：34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measures the level of paternal antenatal attachment to the baby.
Assessment method: The Paternal Antenatal Attachment Scale (PAAS), a 16-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger paternal antenatal attachment.
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34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Maternal postnatal attachment (mothers)
時間枠：6 weeks postpartum
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Measures the level of maternal postnatal attachment to the baby.
Assessment method: The Maternal Postnatal Attachment Scale (MPAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger maternal postnatal attachment.
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6 weeks postpartum
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Paternal postnatal attachment (fathers)
時間枠：6 weeks postpartum
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Measures the level of postnatal attachment to the baby in both mothers and fathers.
Assessment method: The Paternal Postnatal Attachment Scale (PPAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger paternal postnatal attachment.
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6 weeks postpartum
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Psychological flexibility (mothers, partner)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measure of psychological flexibility.
Assessment method: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT), a 10-item self-report scale.
Each item is scored from 1 to 7, with higher scores indicating greater psychological flexibilityTime
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Partnership quality (mothers, partners)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measures the quality of the marital or partnership relationship.
Assessment method: The Quality of Marriage Index (QMI), a 6-item self-report measure.
Some items are scored from 1 to 7 and others from 1 to 10, with higher scores indicating better relationship quality.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Parental role perception (mothers)
時間枠：6 months postpartum
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Measures parents' perception of their competence in the parental role.
Assessment method: The Parental Sense of Competence scale (PSOC), a 21-item self-report measure.
Each item is scored from 1 to 6, with higher scores indicating a stronger sense of parental competence.
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6 months postpartum
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Coparenting dynamics (mothers, partners)
時間枠：6 months postpartum
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Measures the dynamics of coparenting relationships.
Assessment method: The Coparenting Relationship Scale (CRS), a 14-item self-report measure.
Each item is scored from 0 to 6, with higher scores indicating more positive coparenting dynamics.
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6 months postpartum
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Mediterranean diet adherence (mothers, partners)
時間枠：Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measure of adherence to the mediterranean diet.
Assessment method: Mediterranean Diet Adherence Screener (MEDAS), a 14-items self-report instrument.
Each item score from 0 to 1. Higher scores indicate greater adherence to the mediterranean diet.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Maternal physical activity levels (mothers)
時間枠：Baseline, 6 months postpartum
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Measures physical activity levels in pregnant women and mothers.
Assessment method: The Pregnancy Physical Activity Questionnaire (PPAQ), a 33-item self-report measure.
Each item is scored from 0 to 5, with higher scores indicating higher levels of physical activity.
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Baseline, 6 months postpartum
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Physical condition (mothers)
時間枠：Baseline, 6 months postpartum
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Measures overall physical condition and the main components (i.e., cardiorespiratory fitness, muscular strength, speed-agility, and flexibility) in pregnant women and mothers.
Assessment method: The International FItness Scale (IFIS), a 5-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating better physical condition.
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Baseline, 6 months postpartum
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Child temperament (mothers)
時間枠：6 months postpartum
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Measures various aspect of infant temperament.
Assessment method: The Infant Behavior Questionnaire-Revised Short Form (IBQ-R SF), a 37-item self-report measure.
Each item is scored from 1 to 7, with higher scores indicating a higher frequency of the specified temperament behavior.
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6 months postpartum
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Child development (mothers)
時間枠：6 months postpartum
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Measures of various domains of infant development. Assessment method: Ages & Stages Questionnaires (ASQ-3), a self-report measure. Each milestone question is answered using one of three frequency options, which are converted into point values:
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6 months postpartum
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Life quality (mothers, partners)
時間枠：12 months postpartum
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Measures the overall quality of life.
Assessment method: The European Quality of Life-5 Dimensions-5 Levels (EuroQol-5D-5L), a 5-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating worse quality of life
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12 months postpartum
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Identity (mothers, partners)
時間枠：Baseline, 6 months postpartum
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Measure of various domains of identity development.
Assessment method: Dimensions of Identity Development Scale (DIDS)., a 25-items self-report measure.
Each item is scored from 1 to 5, with higher scores indicating greater endorsement of the corresponding identity development dimension.
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Baseline, 6 months postpartum
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Economic data
時間枠：12 months postpartum
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Measures healthcare service utilization and sick leave days over the previous year among participating women.
Assessment method: a post hoc semi-structured interview that collects information on emergency visits, hospital admissions, primary care visits (e.g., nurse, midwife, social worker), secondary care visits, and consultations with specialists.
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12 months postpartum
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Emma Motrico, PhD、University of Seville
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月30日
一次修了 (推定)
2027年12月30日
研究の完了 (推定)
2028年3月30日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年5月25日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月29日
QC基準を満たした最後の更新が送信されました
2026年5月25日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。