Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT07027761
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT07027761
Study Brief:
Protocol Section:
NCT07027761