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

Katri Räikkönen

Status: Enrolling

Conditions: Perinatal Depression

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04069091

001

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,000 participants in 2 patient groups

CBT intervention

Experimental group

Description:

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)

Treatment:

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

Standard care

No Intervention group

Description:

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