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

December 11, 2025 updated by: Kamilla Woznica Miskowiak, Mental Health Services in the Capital Region, Denmark

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2000
        • Frederiksberg Hospital, Mental Health Services - Capital Region of Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Severity of Maternal Depressive Symptoms During the First 6 Weeks Postpartum
Time Frame: Weekly assessments from birth to 6 weeks postpartum
Measured using weekly online ratings on the Edinburgh Postnatal Depression Scale (EPDS). Scores are averaged across the 6-week postpartum period to estimate overall symptom severity.
Weekly assessments from birth to 6 weeks postpartum
Self-Reported Parental Stress at 6 Months Postpartum
Time Frame: 6 months postpartum
Measured using an online questionnaire assessing parental stress levels at 6 months after birth.
6 months postpartum
Parent-Reported Infant Development at 6 Months Postpartum
Time Frame: 6 months postpartum
Measured using an online parent-report questionnaire assessing infant developmental functioning at 6 months of age.
6 months postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Postpartum Depression in Co-Parents Assessed at 6 Months Postpartum
Time Frame: 6 months postpartum
Measured using the Present State Examination (PSE) diagnostic interview at 6 months postpartum to determine whether co-parents meet criteria for postpartum depression.
6 months postpartum
Occurrence of Postpartum Depression in Mothers Whose Co-Parent Also Receives the Intervention
Time Frame: 6 months postpartum
Exploratory comparison evaluating whether mothers whose co-parent also completes the online intervention show lower occurrence of postpartum depression at 6 months postpartum, compared with mothers whose co-parent does not receive the intervention.
6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

Lund University
University of Copenhagen
University of Bergen
University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p-2024-16735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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