PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online prenatal affective cognitive training.
- Who it may be relevant to
- Registry conditions: Post-partum Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be: Identifying and Targeting Cognitive Risk Factors
Overview
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum [Time frame: 6 months postpartum]
Secondary outcome measures (3)
- Average Severity of Maternal Depressive Symptoms During the First 6 Weeks Postpartum [Time frame: Weekly assessments from birth to 6 weeks postpartum]
- Self-Reported Parental Stress at 6 Months Postpartum [Time frame: 6 months postpartum]
- Parent-Reported Infant Development at 6 Months Postpartum [Time frame: 6 months postpartum]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Frederiksberg Hospital, Mental Health Services - Capital Region of Denmark — Copenhagen
Publications
- 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
Identifiers
NCT: NCT07302165 · p-2024-16735