PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be
NCT ID: NCT07302165
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
520 participants
INTERVENTIONAL
2025-08-30
2027-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Online prenatal affective cognitive training
Participants in this arm receive a 4-5-week online intervention consisting 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 independently on the online platform.
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.
Care as usual (CAU)
Participants in this arm receive care-as-usual (CAU) provided within the Danish healthcare system. They do not receive access to the online intervention but complete the same assessments and follow-ups as the intervention group.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Current substance use.
* EPDS score ≥ 11 for women or ≥ 10 for men, indicating clinically relevant depressive symptoms at baseline.
18 Years
ALL
Yes
Sponsors
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University of Bergen
OTHER
University of Copenhagen
OTHER
University of Southern Denmark
OTHER
Lund University
OTHER
Mental Health Services in the Capital Region, Denmark
OTHER
Responsible Party
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Kamilla Woznica Miskowiak
Professor
Locations
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Frederiksberg Hospital, Mental Health Services - Capital Region of Denmark
Copenhagen, , Denmark
Countries
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References
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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.
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.
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.
Other Identifiers
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p-2024-16735
Identifier Type: -
Identifier Source: org_study_id