Post-partum DepressionNCT07302165
PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be
A study testing Online prenatal affective cognitive training in people with Post-partum Depression, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The goal of this randomized controlled study is to evaluate whether an online intervention that combines psychoeducation and affective cognitive training can help prevent postpartum depression in pregnant women and co-parents who have been identified as having risk factors for postpartum depression through an online… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-partum Depression
- What is being tested?
- Online prenatal affective cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Aug 2025to 28 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women in their second or third trimester, or co-parents.
- Age ≥ 18 years.
- Ability to speak and read Danish.
- A cut-off score > 96 on a test of negative cognitive bias (scale 0-100), and/or a score > 23 on the Antenatal Risk Questionnaire (ANRQ).
- Co-parents are categorized as at risk if their partner is identified as having risk factors.
Who cannot join
- Current or past mental disorders within ICD-10 categories F00-F29 and F60-F69.
- Current substance use.
- EPDS score ≥ 11 for women or ≥ 10 for men, indicating clinically relevant depressive symptoms at baseline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Frederiksberg Hospital, Mental Health Services - Capital Region of Denmark
Copenhagen, 2000
About this study
Official title: PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be: Identifying and Targeting Cognitive Risk Factors
The goal of this randomized controlled study is to evaluate whether an online intervention that combines psychoeducation and affective cognitive training can help prevent postpartum depression in pregnant women and co-parents who have been identified as having risk factors for postpartum depression through an online screening tool. A total of 520 expecting parents will be enrolled in the intervention trial.
Researchers will compare the online intervention to care as usual (CAU) in the Danish healthcare system to determine whether the intervention has a better preventive effect. The study also involves a low-risk comparison group (n = 5250) who will not receive the intervention but will complete the same assessments for background comparisons.
Read more
The main question is:
- Does the online intervention reduce the number of mothers who develop postpartum depression during the first six months after birth?
Other questions the study addresses include:
- How severe mothers' depressive symptoms are during the first six weeks postpartum, based on weekly online ratings?
- How do parents report their own stress levels and their infant's development six months after birth?
The study will also explore:
- How many co-parents develop postpartum depression during the first six months postpartum.
- Whether mothers experience additional benefit if their co-parent also completes the intervention.
Participants will:
- Complete a 4-5-week online intervention with 8-9 modules that include psychoeducation and cognitive-affective training.
- Complete online questionnaires and outcome assessments from home.
- Participate in a diagnostic interview by phone after birth.
- Conditions
- Post-partum Depression
- Being tested
- Online prenatal affective cognitive training
- Keywords
- Prevention intervention, Postpartum depression, Digital psychiatry, Online therapy, Risk factors, Pregnancy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online prenatal affective cognitive trainingBehavioural
Participants receive a 4-5 week online intervention concisting of 8-9 modules. The program includes psychoeducation on perinatal emotional health and cognitive-affective training exercises designed to reduce risk factors for postpartum depression. All content is completed idenpendently on the online platform.
| Study group | Role | What they receive |
|---|---|---|
| Online prenatal affective cognitive training | Experimental | Participants in this arm receive a 4-5-week online intervention consisting of 8-9 modules. The program includes psychoeducation on perinatal emotional health and cognitive-affective training exercises designed to reduce risk factors for postpartum depression. All content is completed independently on the online platform. Receives: Behavioral: Online prenatal affective cognitive training |
| Care as usual (CAU) | No intervention | Participants in this arm receive care-as-usual (CAU) provided within the Danish healthcare system. They do not receive access to the online intervention but complete the same assessments and follow-ups as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum
Measured using the Present State Examination (PSE) diagnostic interview at 6 months postpartum to determine whether participants meet criteria for postpartum depression.
Measured: 6 months postpartum
Secondary outcomes (3)
Average Severity of Maternal Depressive Symptoms During the First 6 Weeks Postpartum
Measured using weekly online ratings on the Edinburgh Postnatal Depression Scale (EPDS). Scores are averaged across the 6-week postpartum period to estimate overall symptom severity.
Measured: Weekly assessments from birth to 6 weeks postpartum
Self-Reported Parental Stress at 6 Months Postpartum
Measured using an online questionnaire assessing parental stress levels at 6 months after birth.
Measured: 6 months postpartum
Parent-Reported Infant Development at 6 Months Postpartum
Measured using an online parent-report questionnaire assessing infant developmental functioning at 6 months of age.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start30 Aug 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-partum 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, University of Copenhagen, University of Southern Denmark, Lund University
- Responsible party
- Principal investigator, Kamilla Woznica Miskowiak, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302165
- Sponsor's protocol ID
- p-2024-16735
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bjertrup AJ, Kofoed J, Egmose I, Wendelboe K, Southgate V, Vaever MS, Miskowiak KW. Prenatal affective cognitive training to reduce the risk of postpartum depression (PACT): study protocol for a randomized controlled trial. Trials. 2024 Jul 15;25(1):478. doi: 10.1186/s13063-024-08316-1.
PubMed 39010232Bjertrup AJ, Vaever MS, Miskowiak KW. Prediction of postpartum depression with an online neurocognitive risk screening tool for pregnant women. Eur Neuropsychopharmacol. 2023 Aug;73:36-47. doi: 10.1016/j.euroneuro.2023.04.014. Epub 2023 Apr 27.
PubMed 37119561Bjertrup AJ, Jensen MB, Schjodt MS, Parsons CE, Kjaerbye-Thygesen A, Mikkelsen RL, Moszkowicz M, Frokjaer VG, Vinberg M, Kessing LV, Vaever MS, Miskowiak KW. Cognitive processing of infant stimuli in pregnant women with and without affective disorders and the association to postpartum depression. Eur Neuropsychopharmacol. 2021 Jan;42:97-109. doi: 10.1016/j.euroneuro.2020.10.006. Epub 2020 Nov 3.
PubMed 33158668
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be: Identifying and Targeting Cognitive Risk Factors
- ClinicalTrials.gov ID
- NCT07302165
- Acronym / sponsor ID
- p-2024-16735
- Conditions
- Post-partum Depression
- Keywords
- Prevention intervention, Postpartum depression, Digital psychiatry, Online therapy, Risk factors, Pregnancy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Bergen, University of Copenhagen, University of Southern Denmark, Lund University
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Dec 2025 (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.
The goal of this randomized controlled study is to evaluate whether an online intervention that combines psychoeducation and affective cognitive training can help prevent postpartum depression in pregnant women and co-parents who have been identified as having risk factors for postpartum depression through an online screening tool. A total of 520 expecting parents will be enrolled in the intervention trial.
Researchers will compare the online intervention to care as usual (CAU) in the Danish healthcare system to determine whether the intervention has a better preventive effect. The study also involves a low-risk comparison group (n = 5250) who will not receive the intervention but will complete the same assessments for background comparisons.
The main question is:
- Does the online intervention reduce the number of mothers who develop postpartum depression during the first six months after birth?
Other questions the study addresses include:
- How severe mothers' depressive symptoms are during the first six weeks postpartum, based on weekly online ratings?
- How do parents report their own stress levels and their infant's development six months after birth?
The study will also explore:
- How many co-parents develop postpartum depression during the first six months postpartum.
- Whether mothers experience additional benefit if their co-parent also completes the intervention.
Participants will:
- Complete a 4-5-week online intervention with 8-9 modules that include psychoeducation and cognitive-affective training.
- Complete online questionnaires and outcome assessments from home.
- Participate in a diagnostic interview by phone after birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online prenatal affective cognitive training | Experimental | Behavioral: Online prenatal affective cognitive trainingParticipants in this arm receive a 4-5-week online intervention consisting of 8-9 modules. The program includes psychoeducation on perinatal emotional health and cognitive-affective training exercises designed to reduce risk factors for postpartum depression. All content is completed independently on the online platform. |
| Care as usual (CAU) | No intervention | –Participants in this arm receive care-as-usual (CAU) provided within the Danish healthcare system. They do not receive access to the online intervention but complete the same assessments and follow-ups as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women in their second or third trimester, or co-parents.
- Age ≥ 18 years.
- Ability to speak and read Danish.
- A cut-off score > 96 on a test of negative cognitive bias (scale 0-100), and/or a score > 23 on the Antenatal Risk Questionnaire (ANRQ).
- Co-parents are categorized as at risk if their partner is identified as having risk factors.
Key exclusion criteria (3 listed)
- Current or past mental disorders within ICD-10 categories F00-F29 and F60-F69.
- Current substance use.
- EPDS score ≥ 11 for women or ≥ 10 for men, indicating clinically relevant depressive symptoms at baseline.
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 |
|---|---|---|
| Online prenatal affective cognitive trainingParticipants receive a 4-5 week online intervention concisting of 8-9 modules. The program includes psychoeducation on perinatal emotional health and cognitive-affective training exercises designed to reduce risk factors for postpartum depression. All content is completed idenpendently on the online platform. | Behavioural | Online prenatal affective cognitive training |
Primary outcome
Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum
Time frame: 6 months postpartum
Measured using the Present State Examination (PSE) diagnostic interview at 6 months postpartum to determine whether participants meet criteria for postpartum depression.
3 secondary outcomes
Average Severity of Maternal Depressive Symptoms During the First 6 Weeks Postpartum
Time frame: Weekly assessments from birth to 6 weeks postpartum
Self-Reported Parental Stress at 6 Months Postpartum
Time frame: 6 months postpartum
Parent-Reported Infant Development at 6 Months Postpartum
Time frame: 6 months postpartum
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 24 Dec 2025.
- Results publication: PubMed 39010232Bjertrup AJ, Kofoed J, Egmose I, Wendelboe K, Southgate V, Vaever MS, Miskowiak KW. Prenatal affective cognitive training to reduce the risk of postpartum depression (PACT): study protocol for a randomized controlled trial. Trials. 2024 Jul 15;25(1):478. doi: 10.1186/s13063-024-08316-1.
- Results publication: PubMed 37119561Bjertrup AJ, Vaever MS, Miskowiak KW. Prediction of postpartum depression with an online neurocognitive risk screening tool for pregnant women. Eur Neuropsychopharmacol. 2023 Aug;73:36-47. doi: 10.1016/j.euroneuro.2023.04.014. Epub 2023 Apr 27.
- Results publication: PubMed 33158668Bjertrup AJ, Jensen MB, Schjodt MS, Parsons CE, Kjaerbye-Thygesen A, Mikkelsen RL, Moszkowicz M, Frokjaer VG, Vinberg M, Kessing LV, Vaever MS, Miskowiak KW. Cognitive processing of infant stimuli in pregnant women with and without affective disorders and the association to postpartum depression. Eur Neuropsychopharmacol. 2021 Jan;42:97-109. doi: 10.1016/j.euroneuro.2020.10.006. Epub 2020 Nov 3.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online prenatal affective cognitive training in people with Post-partum Depression, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 5 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: enrolling by invitation, as of the sponsor's last update on 24 Dec 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 Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum (time frame: 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07302165, which also lists 3 linked publications.
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 24 Dec 2025.