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

NCT07302165 | Enrolling By Invitation

• 1 other identifier: p-2024-16735
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-partum Depression

Keywords

Prevention intervention; Postpartum depression; Digital psychiatry; Online therapy; Risk factors; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum

  Measured using the Present State Examination (PSE) diagnostic interview at 6 months postpartum to determine whether participants meet criteria for postpartum depression.

  6 months postpartum

Secondary Outcomes (3)

• Average Severity of Maternal Depressive Symptoms During the First 6 Weeks Postpartum

  Weekly assessments from birth to 6 weeks postpartum

• Self-Reported Parental Stress at 6 Months Postpartum

  6 months postpartum

• Parent-Reported Infant Development at 6 Months Postpartum

  6 months postpartum

Other Outcomes (2)

• Occurrence of Postpartum Depression in Co-Parents Assessed at 6 Months Postpartum

  6 months postpartum

• Occurrence of Postpartum Depression in Mothers Whose Co-Parent Also Receives the Intervention

  6 months postpartum

Study Arms (2)

Online prenatal affective cognitive training

EXPERIMENTAL

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.

Behavioral: Online prenatal affective cognitive training

Care as usual (CAU)

NO INTERVENTION

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.

Interventions

Online prenatal affective cognitive training BEHAVIORAL

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.

Online prenatal affective cognitive training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Bergen: collaborator
• University of Copenhagen: collaborator
• University of Southern Denmark: collaborator
• Lund University: collaborator

Study Sites (1)

Frederiksberg Hospital, Mental Health Services - Capital Region of Denmark

Copenhagen, 2000, Denmark

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)