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NCT Number: NCT04069091

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

Primary outcomes

  1. Depressive symptoms

    Time frame: Measured immediately after intervention at 26-28 gestational weeks

    The primary outcome in the women is depressive symptoms measured using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a self-report questionnaire consisting of a single scale of 10 items, each rated 0-3. Higher total scores (range 0-30) indicate more depressive symptomatology, and scores of at least 10 indicate clinically relevant depressive symptoms, i.e. probable depression.

  2. Child developmental milestones

    Time frame: Measured at 3 months of corrected age after childbirth

    The primary outcome in the children is child developmental milestones measured using the Ages and Stages-3 questionnaires (ASQ-3). The ASQ-3 comprises 30 age-appropriate items measuring communication, gross motor, fine motor, problem solving and personal/social skills. Each domain comprises six questions with response 'yes' (scored 10) indicating the child can master the skill, 'sometimes' (scored 5) if the skill is emerging or occasional, and 'not yet' (scored 0) if the child is not able perform the skill. Highest domain scores (range 0-60) indicate mastery of the skill. On each domain, scores over 2 standard deviations (SD) below the mean for the age indicate developmental delay, scores between 1-2 SDs below the mean indicate mild developmental delay, and scores higher than one SD below the mean indicate typical development.

Study contacts

Contact information is provided by the study sponsor or research team.

Jaana Palukka, PhD

CONTACT

[email protected]

+3580452783969

Katri Räikkönen, PhD

CONTACT

[email protected]

+358405121469

Sponsors and collaborators

Lead sponsor

Katri Räikkönen

Other

Collaborators

  • Helsinki University Central Hospital

Registry information

Acronym: IMPRINT

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2019
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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