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

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital146 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

146

Conditions

Postpartum Depression Emotional Regulation

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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)

Time frame: Six months after birth

Secondary Outcomes

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

Time frame: 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

Time frame: Within six weeks after birth

Self-rated parental stress

Self-rated parental stress with the Parental Stress Scale at six months after birth.