Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)

Study Overview
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Brief Summary
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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 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.

Official Title
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Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial

Conditions
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Postpartum Depression, Emotional Regulation, Cognitive Function 1, Social, Pregnancy Related, Mother-Child Relations

Intervention / Treatment
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* Other: Prenatal Affective CogntiiveTraining


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACT<br>Receive the intervention | Other: Prenatal Affective CogntiiveTraining<br>* A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation<br>|
| No Intervention: CAU<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post partum depression | Occurence of depression and depression severity during the first six months after birth | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Affective cognition | The reduction in negatively biased cognitive processing of infant stimuli from baseline to follow-up during pregnancy, as well as the self-rated parental stress after birth. | Ten months |