NCT04069091: IMPRINT

Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health

Recruiting now NA Last updated 30 September 2025

What this trial tests

NA trial testing 'Enjoy your Bump' (iloodottaa.fi) online self-help intervention in Perinatal Depression in 1,000 participants. Currently enrolling.

Timeline

1 January 2020

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	Katri Räikkönen
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,000
Start date	1 January 2020
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	1 location across Finland

Drugs / interventions tested

• 'Enjoy your Bump' (iloodottaa.fi) online self-help intervention

Conditions studied

• Perinatal Depression — all drugs for Perinatal Depression →

Sponsor

Katri Räikkönen

Who can join

Eligibility, female only, with Perinatal Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.