Actively Recruiting
Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health
Led by Katri Räikkönen · Updated on 2025-09-30
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Katri Räikkönen
Lead Sponsor
H
Helsinki University Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying maternal perinatal depression, the most common complication during pregnancy, which affects both mothers and their children's early development. This trial aims to improve maternal and child health by screening, treating, and preventing perinatal depression using a culturally adapted low-intensity online cognitive behavioral therapy (CBT) program called 'Enjoy your Bump'. The study initially planned as a cluster-randomized trial now uses a single-arm design due to recruitment challenges, enrolling pregnant women from multiple antenatal clinics in various Finnish regions. Participants receive standard antenatal care alongside the 'Enjoy your Bump' online self-help intervention that uses CBT techniques such as empathic communication, problem-solving, behavioral activation, and addressing negative thoughts and low confidence. The intervention is tailored to the Finnish cultural and healthcare context. Women undergo this program during pregnancy, focusing on improving depressive symptoms and supporting mental health. Throughout the study, women are assessed for depressive symptoms immediately after the intervention at 26-28 weeks of gestation. Child developmental milestones are evaluated at three months of corrected age after birth. The trial monitors outcomes related to symptom severity, child development, and the influence of biological, psychological, and social factors. The study aims to recruit 500 women for the intervention and measures the impact on both mother and child over time.
CONDITIONS
Brief Title
Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- EPDS screen result of 10 or more
- Agreed to be invited for the intervention during the screening phase
- Female gender
You will not qualify if you...
- Active suicidality
- Presence of severe mental disorder
- Concurrent use of psychotropic medication or psychosocial treatment for mental disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 to 16 weeks until 26-28 gestational weeks
Participants in the CBT intervention arm participate in the 'Enjoy your Bump' online self-help intervention using cognitive behavioral therapy techniques alongside their standard antenatal care. Participants in the standard care arm continue with routine antenatal care without additional intervention.
Online self-help with standard antenatal care visits as scheduled
Duration - Approximately 3 months after childbirth
Participants are assessed for depressive symptoms immediately after the intervention and child developmental milestones at 3 months after childbirth.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 1 location
1
University of Helsinki
Helsinki, Uusimaa, Finland, 00014
Actively Recruiting
Research Team
K
Katri Räikkönen, PhD
J
Jaana Palukka, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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