Clinical trial NCT04069091: Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health
Official title: Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Depressive symptoms
timeFrame: Measured immediately after intervention at 26-28 gestational weeks
measure: Depressive symptoms
timeFrame: Measured immediately after delivery
measure: Depressive symptoms
timeFrame: Measured 8-10 weeks after pregnancy
measure: Depressive symptoms
timeFrame: Measured at 1 year child's corrected age
measure: Depressive symptoms
timeFrame: Measured at 2 years child's corrected age
measure: Child developmental milestones
timeFrame: Measured at 8-10 weeks after pregnancy
measure: Child developmental milestones
timeFrame: Measured at 1 year child's corrected age
measure: Child developmental milestones
timeFrame: Measured at 2 years child's corrected age
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
state: Uusimaa
Study officials:
affiliation: University of Helsinki
name: Katri Räikkönen, PhD
role: PRINCIPAL_INVESTIGATOR
References: