Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Denmark / NCT07302165
Enrolling by invitation Not applicable

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

NCT07302165 · tracked via the Priya Life Science Denmark tracker
Sponsor
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Phase
Not applicable
Started
2025-08-30
Last updated
2025-12-24

Condition(s) studied

Post-partum Depression

Investigational drug(s) / intervention(s)

Online prenatal affective cognitive training

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

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

Trial sites (1)

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

More Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital trials in Denmark

Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa Active, not recruiting
PROspective Longitudinal All-comer Inclusion Study in Eating Disorders Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives Recruiting
The VIA Family 2.0 - a Family Based Intervention for Families with Parental Mental Illness Recruiting
Daylight-controlled Lighting Adjusted for Geographical Orientation : Effects on Recovery, Energy Consumption and User Satisfaction Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07302165 on ClinicalTrials.gov ↗ ← All trials in Denmark