MedTrace Logo

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

NCT07302165 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2025-12-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Lund University

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302165 on ClinicalTrials.gov