PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be

Официальное название

PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be: Identifying and Targeting Cognitive Risk Factors

Обзор

The goal of this randomized controlled study is to evaluate whether an online intervention that combines psychoeducation and affective cognitive training can help prevent postpartum depression in pregnant women and co-parents who have been identified as having risk factors for postpartum depression through an online screening tool. A total of 520 expecting parents will be enrolled in the intervention trial. Researchers will compare the online intervention to care as usual (CAU) in the Danish healthcare system to determine whether the intervention has a better preventive effect. The study also involves a low-risk comparison group (n = 5250) who will not receive the intervention but will complete the same assessments for background comparisons. The main question is: \- Does the online intervention reduce the number of mothers who develop postpartum depression during the first six months after birth? Other questions the study addresses include: * How severe mothers' depressive symptoms are during the first six weeks postpartum, based on weekly online ratings? * How do parents report their own stress levels and their infant's development six months after birth? The study will also explore: * How many co-parents develop postpartum depression during the first six months postpartum. * Whether mothers experience additional benefit if their co-parent also completes the intervention. Participants will: * Complete a 4-5-week online intervention with 8-9 modules that include psychoeducation and cognitive-affective training. * Complete online questionnaires and outcome assessments from home. * Participate in a diagnostic interview by phone after birth.

Вмешательства

• Поведенческое Online prenatal affective cognitive training
  Participants receive a 4-5 week online intervention concisting of 8-9 modules. The program includes psychoeducation on perinatal emotional health and cognitive-affective training exercises designed to reduce risk factors for postpartum depression. All content is completed idenpendently on the online platform.

Первичные конечные точки

• Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum [Срок оценки: 6 months postpartum]

Вторичные конечные точки (3)

• Average Severity of Maternal Depressive Symptoms During the First 6 Weeks Postpartum [Срок оценки: Weekly assessments from birth to 6 weeks postpartum]
• Self-Reported Parental Stress at 6 Months Postpartum [Срок оценки: 6 months postpartum]
• Parent-Reported Infant Development at 6 Months Postpartum [Срок оценки: 6 months postpartum]

Критерии участия

Критерии включения

• Pregnant women in their second or third trimester, or co-parents.
• Age ≥ 18 years.
• Ability to speak and read Danish.
• A cut-off score > 96 on a test of negative cognitive bias (scale 0-100), and/or a score > 23 on the Antenatal Risk Questionnaire (ANRQ).
• Co-parents are categorized as at risk if their partner is identified as having risk factors.

Критерии исключения

• Current or past mental disorders within ICD-10 categories F00-F29 and F60-F69.
• Current substance use.
• EPDS score ≥ 11 for women or ≥ 10 for men, indicating clinically relevant depressive symptoms at baseline.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

• Frederiksberg Hospital, Mental Health Services - Capital Region of Denmark — Copenhagen

Публикации

• Bjertrup AJ, Kofoed J, Egmose I, Wendelboe K, Southgate V, Vaever MS, Miskowiak KW. Prenatal affective cognitive training to reduce the risk of postpartum depression (PACT): study protocol for a randomized controlled trial. Trials. 2024 Jul 15;25(1):478. doi: 10.1186/s13063-024-08316-1. PMID 39010232
• Bjertrup AJ, Vaever MS, Miskowiak KW. Prediction of postpartum depression with an online neurocognitive risk screening tool for pregnant women. Eur Neuropsychopharmacol. 2023 Aug;73:36-47. doi: 10.1016/j.euroneuro.2023.04.014. Epub 2023 Apr 27. PMID 37119561
• Bjertrup AJ, Jensen MB, Schjodt MS, Parsons CE, Kjaerbye-Thygesen A, Mikkelsen RL, Moszkowicz M, Frokjaer VG, Vinberg M, Kessing LV, Vaever MS, Miskowiak KW. Cognitive processing of infant stimuli in pregnant women with and without affective disorders and the association to postpartum depression. Eur Neuropsychopharmacol. 2021 Jan;42:97-109. doi: 10.1016/j.euroneuro.2020.10.006. Epub 2020 Nov 3. PMID 33158668

Идентификаторы

NCT: NCT07302165 · p-2024-16735

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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