Feasibility and Implementation of Early Referral in Perinatal Mental Health (e-Perinatal-Re)
Feasibility, Acceptability, and Preliminary Effectiveness of Early Referral Strategy to Specialized Mental Health Services: An Embedded Implementation Study
調査の概要
状態
詳細な説明
This embedded study evaluates the implementation of the e-Perinatal app as a screening tool to facilitate early referral to specialized mental health services within routine primary healthcare settings.
The study will be conducted within the context of the main e-Perinatal trial in primary healthcare centers in Andalusia, Spain. Participants will include pregnant and postpartum women enrolled in the main study who are at risk of presenting maternal perinatal depression and/or anxiety disorders, based on a structured clinical interview.
The primary objective is to assess the feasibility and acceptability of an early referral in routine care. The secondary aim is to validate and implement an Artificial Intelligence-based algorithm for the early screening of mental health disorders in routine services.
Data will be collected using questionnaires, clinical records, and semi-structured interviews with participants and healthcare professionals.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Emma Motrico, PhD
- 電話番号：0034636995778
- メール：eperinatal@us.es
研究場所
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Sevilla
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Mairena del Aljarafe、Sevilla、スペイン、41927
- 募集
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
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コンタクト：
- Ana Belén Naranjo Saucedo,, MSc
- 電話番号：+34 676426430
- メール：ana.naranjo@juntadeandalucia.es
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参加基準
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
説明
Inclusion Criteria:
- Pregnant and postpartum women enrolled in the main e-Perinatal trial, indicating the presence of a depressive or anxiety disorder with CIDI.
- Access to smartphone and internet
- Able to write and read in Spanish
Exclusion Criteria:
- None beyond those defined in the main trial
研究計画
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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Feasibility of referral strategy
時間枠：Baseline, 12 months postpartum
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Assessment method: Recruitment rates, retention rates
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Baseline, 12 months postpartum
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Acceptability of the referral
時間枠：through study completion, an average of 18 months
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Acceptability of referral will be assessed using an ad hoc self-report assessment.
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through study completion, an average of 18 months
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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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Identification of at-risk participants
時間枠：through study completion, an average of 18 months
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Measure of the number of at-risk participants.
Participants will be considered at risk if they score above the clinical cutoff on at least one of the two scales (Edinburgh Postnatal Depression Scale (EPDS) ≥ 12 and/or Generalized Anxiety Disorder-7 (GAD-7) ≥ 10), measuring the severity of the depression and anxiety symptoms, respectively.
EPDS and GAD-7 will be collected within the e-Perinatal app.
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through study completion, an average of 18 months
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Referral to specialized mental health services
時間枠：through study completion, an average of 18 months
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Number of referral to specialized mental health services, as recorded in clinical records.
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through study completion, an average of 18 months
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Time to referral
時間枠：through study completion, an average of 18 months
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Assessment method: Time between identification and referral
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through study completion, an average of 18 months
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Engagement with mental health services
時間枠：through study completion, an average of 18 months
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Number of accesses to specialized mental health services, as recorded in clinical records.
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through study completion, an average of 18 months
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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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Follow-up period
時間枠：12 months
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Assessment method: Semi-structured interviews (Normalization Process Theory)
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12 months
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Healthcare professional engagement
時間枠：12 months
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Assessment method: semi-structured interviews
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12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Emma Motrico, PhD、University of Seville
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。