Clinical and Cost-effectiveness of an Online Self-help Intervention and a Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jun 10, 2025

Keywords

ClinConnect Summary

This study is looking at ways to help pregnant women or new mothers who have a moderate chance of developing depression during pregnancy or within the first year after giving birth. Researchers want to see if two different types of support—a self-help program that you can do online, and a short face-to-face counseling session—work better than the usual care mothers receive. They will also check which option is more affordable and whether women find these treatments helpful and easy to use.

Women who take part will come from a larger group already being studied and will be chosen based on a special method that looks at different personal, social, and health factors to predict their risk of depression. To join, mothers need to be at moderate risk and not currently receiving other mental health treatments for pregnancy-related issues. Participants will be randomly assigned to one of the two new support options or to continue with usual care. For those in face-to-face sessions, the first two meetings will be recorded (with permission) to help understand their experience better. This study aims to find better ways to support mothers’ mental health during this important time for them and their families.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Participants will be drawn from the broader PRIL (Perinatal mental health Profiling and Intervention in Leuven) study, who consented to being contacted for the intervention trial and who meet criteria for moderate risk for perinatal depression based on an analytical epidemiological approach aligned with precision medicine principles, specifically a concentration-of-risk prediction modeling approach. Based on a comprehensive assessment of biological, psychological and social risk and protective factors, concentration-of-risk models will be developed and validated to stratify respondents in terms of risk for future perinatal depression, namely (1) not, (2) mildly, (3) moderately and (4) highly at risk of developing perinatal depression. Mothers falling into the moderate risk profile are eligible to participate
• Exclusion Criteria:
• • Receiving concurrent psychological guidance in perinatal mental health problems;
• • Not consenting to (a) audiorecording of the first two face-to-face sessions and/or (b) paying the appropriate fee, in case of randomization to the face-to-face intervention arm.