Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT) (NCT06046456) | Clinical Trial Compass
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Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
Denmark146 participantsStarted 2023-01-10
Plain-language 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. 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for General Pregnant Population:
* Second or third trimester pregnancy.
* Age ≥ 18 years.
* Ability to speak and read Danish.
Inclusion Criteria for High-Risk Pregnant Group:
* 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:
* 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).
Inclusion Criteria for Low-Risk Pregnant Group:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: Six months after birth
Trial details
NCT IDNCT06046456
SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital