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

NCT ID: NCT04069091

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2027-12-31

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.

Conditions

Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CBT intervention

Participants in the CBT intervention arm will undergo standard antenatal care and the 'Enjoy your Bump' (iloodottaa.fi) online self-help intervention employing elements of cognitive behavioral therapy (CBT)

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

The intervention employs elements of cognitive behavioral therapy: empathic, clear and sensitive communication with women and their families, problem self-formulation of solutions to problems, behavioral activation, identification and changing negative automated negative thoughts, addressing low confidence, and promoting problem- solving and relapse prevention.

The Enjoy your Bump intervention has been adapted to the Finnish culture and healthcare setting (ilodottaa.fi).

Standard care

Participants in the Standard Care arm will undergo standard antenatal care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

The intervention employs elements of cognitive behavioral therapy: empathic, clear and sensitive communication with women and their families, problem self-formulation of solutions to problems, behavioral activation, identification and changing negative automated negative thoughts, addressing low confidence, and promoting problem- solving and relapse prevention.

The Enjoy your Bump intervention has been adapted to the Finnish culture and healthcare setting (ilodottaa.fi).

Intervention Type: BEHAVIORAL

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Katri Räikkönen

OTHER

Sponsor Role: lead

Responsible Party

Katri Räikkönen

Professor of Psychology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Katri Räikkönen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

University of Helsinki

Helsinki, Uusimaa, Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Katri Räikkönen, PhD

Role: CONTACT

katri.raikkonen@helsinki.fi

+358405121469

Jaana Palukka, PhD

Role: CONTACT

tutkimushoitaja@iloodottaa.fi

+3580452783969

Facility Contacts

Katri Raikkonen, PhD

Role: primary

katri.raikkonen@helsinki.fi

+358405121469

Jaana Palukka, RN

Role: backup

tutkimushoitaja@iloodottaa.fi

+358452783969

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id