Postpartum DepressionPACTNCT06046456
Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
A study testing Prenatal Affective CogntiiveTraining in people with Postpartum Depression and Emotional Regulation, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
Many pregnant women face the risk of experiencing depression after giving birth, especially if they've previously dealt with depression. The goal of this study, is to test if our newly developed Prenatal Affective Cognitive Training (PACT) intervention, can decrease the likelihood of post partum depression. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Emotional Regulation, Cognitive Function 1, Social
- What is being tested?
- Prenatal Affective CogntiiveTraining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Second or third trimester pregnancy.
- Age ≥ 18 years.
- Ability to speak and read Danish.
- Either:
- Negative cognitive bias in emotional reactivity to infant distress (cut-off > 96 on a scale from 0-100).
- High-risk status according to the Antenatal Risk Questionnaire (ANRQ) which means:
Show all 17Show fewer
- Personal history of severe mental illness.
- Experienced childhood emotional, physical, or sexual abuse.
- Total score on psycho-social risk factors is above the cut-off (> 23).
- Absence of a personal or family history of mental illness.
- Absence of negative bias.
- Three or fewer of the additional risk factors mentioned above.
- General Exclusion Criteria:
- Schizophrenia.
- Current substance use disorder.
- Score of 9 or more on the Hamilton Depression Rating Scale-6 items (HDRS-6), indicating moderate depression.
- Pregnant women diagnosed with a personality disorder (note: they will still be included at baseline and follow-up after birth but will be excluded from randomization).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Services in The Capital Region of Denmark
Copenhagen, 2000
Anne J Bjertrup, PhD, 27134839, anne.juul.bjertrup@regionh.dk
About this study
Official title: Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial
Many pregnant women face the risk of experiencing depression after giving birth, especially if they've previously dealt with depression.
The goal of this study, is to test if our newly developed Prenatal Affective Cognitive Training (PACT) intervention, can decrease the likelihood of post partum depression. In the study, 226 pregnant women, some of whom are considered high risk due to past mental illness or psycho-social risk factors, will participate. The high-risk women will be divided into two groups. One group will undergo the PACT training, which involves computer and virtual reality exercises spanning five weeks, designed to improve mood and emotional regulation. The other group will receive usual care. The study also involves a low-risk group (n=146), although these individuals are not part of the intervention trial but are merely followed up with the same assessments for background comparisons.The main aim is to observe whether the women who undergo PACT intervention are less prone to depression after childbirth compared to those who do not.
This study has potential to offer a simple, non-invasive method to bolster mental health in expectant mothers, which could also positively impact their infants.
- Conditions
- Postpartum Depression, Emotional Regulation, Cognitive Function 1, Social, Pregnancy Related, Mother-Child Relations
- Being tested
- Prenatal Affective CogntiiveTraining
- Medical subject headings
- Depression, Postpartum, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal Affective CogntiiveTrainingOther
A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation
| Study group | Role | What they receive |
|---|---|---|
| PACT | Experimental | Receive the intervention Receives: Other: Prenatal Affective CogntiiveTraining |
| CAU | No intervention | Receive care as usual, i.e., the standard care provided to pregnant women without any additional experimental interventions. It typically involves routine prenatal care, which may include regular check-ups, medical assessments, and general support from healthcare professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PPD during the first six months after birth, assessed with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
The primary outcome is the difference between mothers receiving PACT versus CAU in the incidence of PPD during the first six months after birth, assessed by a clinician blind to group status with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
Measured: Six months after birth
Secondary outcomes (3)
Change in negative cognitive bias
Differences between participants receiving PACT and CAU in the change in negatively biased cognitive processing of infant stimuli from baseline to follow-up during pregnancy (T1) as measured with computerized testing
Measured: In third trimester of pregnancy
Self-rated depressive symptoms
Differences between participants receiving PACT and CAU in severity of depressive symptoms during the first six weeks after birth measured with the Edinburgh Postpartum Depression Scale
Measured: Within six weeks after birth
Self-rated parental stress
Self-rated parental stress with the Parental Stress Scale at six months after birth.
Measured: Six months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start10 Jan 2023
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum 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
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Kamill W Miskowiak, DMsc, Principal investigator, Mental Health Services in the Capital Region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046456
- Sponsor's protocol ID
- R7-A182
- Acronym
- PACT
- Status last verified
- Aug 2023
- First submitted
- 14 Sep 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjertrup A, Rasmussen KH, Torring S, Miskowiak KW. Targeting affective cognition during pregnancy to prevent postpartum depression: a randomized controlled trial with parity-specific effects. Eur Neuropsychopharmacol. 2026 Oct 18;114:113885. doi: 10.1016/j.euroneuro.2026.113885. Online ahead of print.
PubMed 42893683Bjertrup 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 39010232
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06046456
- Acronym / sponsor ID
- PACT / R7-A182
- Conditions
- Postpartum Depression, Emotional Regulation, Cognitive Function 1, Social, Pregnancy Related, Mother-Child Relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
Many pregnant women face the risk of experiencing depression after giving birth, especially if they've previously dealt with depression.
The goal of this study, is to test if our newly developed Prenatal Affective Cognitive Training (PACT) intervention, can decrease the likelihood of post partum depression. In the study, 226 pregnant women, some of whom are considered high risk due to past mental illness or psycho-social risk factors, will participate. The high-risk women will be divided into two groups. One group will undergo the PACT training, which involves computer and virtual reality exercises spanning five weeks, designed to improve mood and emotional regulation. The other group will receive usual care. The study also involves a low-risk group (n=146), although these individuals are not part of the intervention trial but are merely followed up with the same assessments for background comparisons.The main aim is to observe whether the women who undergo PACT intervention are less prone to depression after childbirth compared to those who do not.
This study has potential to offer a simple, non-invasive method to bolster mental health in expectant mothers, which could also positively impact their infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACT | Experimental | Other: Prenatal Affective CogntiiveTrainingReceive the intervention |
| CAU | No intervention | –Receive care as usual, i.e., the standard care provided to pregnant women without any additional experimental interventions. It typically involves routine prenatal care, which may include regular check-ups, medical assessments, and general support from healthcare professionals |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Second or third trimester pregnancy.
- Age ≥ 18 years.
- Ability to speak and read Danish.
- Either:
- Negative cognitive bias in emotional reactivity to infant distress (cut-off > 96 on a scale from 0-100).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Prenatal Affective CogntiiveTrainingA psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation | Other | PACT |
Primary outcome
The incidence of PPD during the first six months after birth, assessed with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
Time frame: Six months after birth
The primary outcome is the difference between mothers receiving PACT versus CAU in the incidence of PPD during the first six months after birth, assessed by a clinician blind to group status with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
3 secondary outcomes
Change in negative cognitive bias
Time frame: In third trimester of pregnancy
Self-rated depressive symptoms
Time frame: Within six weeks after birth
Self-rated parental stress
Time frame: Six months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Derived from this study: PubMed 42893683Bjertrup A, Rasmussen KH, Torring S, Miskowiak KW. Targeting affective cognition during pregnancy to prevent postpartum depression: a randomized controlled trial with parity-specific effects. Eur Neuropsychopharmacol. 2026 Oct 18;114:113885. doi: 10.1016/j.euroneuro.2026.113885. Online ahead of print.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kamill W Miskowiak, DMsc principal investigator
Mental Health Services in the Capital Region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Affective CogntiiveTraining in people with Postpartum Depression and Emotional Regulation, 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 17 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne J Bjertrup, PhD (27134839, anne.juul.bjertrup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PPD during the first six months after birth, assessed with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN) (time frame: Six months after birth). 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 NCT06046456, which also lists 2 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 8 Jul 2024.