Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07302165

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Post-partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frederiksberg Hospital, Mental Health Services - Capital Region of Denmark

Copenhagen, 2000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.