By InvitationNot Applicable

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

Denmark520 participantsStarted 2025-08-30

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum

Timeframe: 6 months postpartum

Trial details

NCT IDNCT07302165

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-28

View on ClinicalTrials.gov More Post-partum Depression trials