NCT04069091 Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health
| NCT ID | NCT04069091 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Katri Räikkönen |
| Condition | Perinatal Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2020-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
IMPRINT strengthens maternal and child health by screening, treating and preventing maternal perinatal depression, the most common complication of pregnancy and the child's first 1000 days. It is associated with poor pregnancy outcome and perinatal mortality and has adverse consequences on physical and mental development of the child. Yet, only 7-28% of women with perinatal depression worldwide receive appropriate evidence-based care. This is astounding given that the need of investing on mental health is widely recognized and low-intensity interventions not requiring costly mental health professionals have been shown to be effective. IMPRINT improves the effectiveness, reliability, safety, appropriateness, equity and efficiency of routine health care provided for the mother and the child during the child's first 1000 days of life. The investigators 1) have adapted into the gender-, country-, and cultural-context an existing evidence-based, low-intensity pregnancy intervention targeting maternal perinatal depression (online CBT-based therapy) (iloodottaa.fi); 2) test in cluster-randomised trial the short- and long-term efficacy of the intervention in women who report clinically relevant, subthreshold or more severe symptoms in an early pregnancy depression screen; 3) study biological, psychological and social determinants of depressive symptom severity, comorbidities and response to interventions. The study recruits women from 58 antenetal clinics in the cities of Helsinki, Vantaa, Keski-Uusimaa, Kuopio and Lohja and aims at recruiting 500 women to the intervention and 500 women to the control arms. Because of low recruitment rate, the cluster-randomized clinical trial design was changed to a single-arm clinical trial. All pregnant mothers who meet the inclusion criteria are eligible to participate in the CBT-intervention. In parallel with the change in study design, recruitment expanded to cover all antenatal clinical in the well-being services counties: Helsinki, Vantaa and Kerava, Central Uusimaa, Western Uusimaa (Lohja), Eastern Finland, and Pirkanmaa. Amendment to HUS ethical committee, approval date: June 26 2024; Amendment to HUS research permit, approval date: August 8 2024; Approvals from the counties participating in the study, approval dates: by October 31 2024.
Eligibility Criteria
Inclusion Criteria: * EPDS screen result of 10 or more * Agreed to be invited for the intervention during the screening phase Exclusion Criteria: * Active suicidality * Presence of severe mental disorder * Concurrent use of psychotropic medication / concurrently under psychosocial treatment for mental disorder
Contact & Investigator
Katri Räikkönen, PhD
PRINCIPAL INVESTIGATOR
University of Helsinki
Frequently Asked Questions
Who can join the NCT04069091 clinical trial?
This trial is open to female participants only, studying Perinatal Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04069091 currently recruiting?
Yes, NCT04069091 is actively recruiting participants. Contact the research team at katri.raikkonen@helsinki.fi for enrollment information.
Where is the NCT04069091 trial being conducted?
This trial is being conducted at Helsinki, Finland.
Who is sponsoring the NCT04069091 clinical trial?
NCT04069091 is sponsored by Katri Räikkönen. The principal investigator is Katri Räikkönen, PhD at University of Helsinki. The trial plans to enroll 1,000 participants.
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