Perinatal DepressionIMPRINTNCT04069091
Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health
A study testing 'Enjoy your Bump' (iloodottaa.fi) online self-help intervention in people with Perinatal Depression, run by Katri Räikkönen at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- 'Enjoy your Bump' (iloodottaa.fi) online self-help intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- EPDS screen result of 10 or more
- Agreed to be invited for the intervention during the screening phase
Who cannot join
- Active suicidality
- Presence of severe mental disorder
- Concurrent use of psychotropic medication / concurrently under psychosocial treatment for mental disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
University of Helsinki
Helsinki, Uusimaa, 00014
Katri Raikkonen, PhD, +358405121469, katri.raikkonen@helsinki.fi
Jaana Palukka, RN, +358452783969, tutkimushoitaja@iloodottaa.fi
About this study
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
- Being tested
- 'Enjoy your Bump' (iloodottaa.fi) online self-help intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Enjoy your Bump' (iloodottaa.fi) online self-help interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| CBT intervention | Experimental | 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) Receives: Behavioral: 'Enjoy your Bump' (iloodottaa.fi) online self-help intervention |
| Standard care | No intervention | Participants in the Standard Care arm will undergo standard antenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
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.
Measured: Measured immediately after intervention at 26-28 gestational weeks
Child developmental milestones
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.
Measured: Measured at 3 months of corrected age after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Please note, that November 1 2024, the study design was changed to a single-arm clinical trial; previous a two-arm cluster-randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katri Räikkönen
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Sponsor-investigator, Katri Räikkönen, University of Helsinki
- Investigators
- Katri Räikkönen, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069091
- Sponsor's protocol ID
- 001
- Acronym
- IMPRINT
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health
- ClinicalTrials.gov ID
- NCT04069091
- Acronym / sponsor ID
- IMPRINT / 001
- Conditions
- Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Katri RäikkönenUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Please note, that November 1 2024, the study design was changed to a single-arm clinical trial; previous a two-arm cluster-randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| CBT intervention | Experimental | Behavioral: 'Enjoy your Bump' (iloodottaa.fi) online self-help interventionParticipants 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) |
| Standard care | No intervention | –Participants in the Standard Care arm will undergo standard antenatal care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- EPDS screen result of 10 or more
- Agreed to be invited for the intervention during the screening phase
Key exclusion criteria (3 listed)
- Active suicidality
- Presence of severe mental disorder
- Concurrent use of psychotropic medication / concurrently under psychosocial treatment for mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Enjoy your Bump' (iloodottaa.fi) online self-help interventionThe 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). | Behavioural | CBT intervention |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Perinatal Depression
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e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
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Fathers and Babies (FAB) Research Study
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Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
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Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katri Räikkönen, PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Enjoy your Bump' (iloodottaa.fi) online self-help intervention in people with Perinatal Depression, run by Katri Räikkönen at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katri Räikkönen, PhD (+358405121469, katri.raikkonen@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Measured immediately after intervention at 26-28 gestational weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.