University of Helsinki
Helsinki, Uusimaa, 00014, Finland
Location status: Recruiting
Location contact
Jaana Palukka, RN
CONTACT
Katri Raikkonen, PhD
CONTACT
NCT Number: NCT04069091
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.
Interested in participating?
Request InfoFemale
Interventional
Not applicable
Helsinki, Uusimaa, 00014, Finland
Location status: Recruiting
Jaana Palukka, RN
CONTACT
Katri Raikkonen, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Jaana Palukka, PhD
CONTACT
Katri Räikkönen, PhD
CONTACT
Katri Räikkönen
Other
Acronym: IMPRINT
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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