An interventional study of Prenatal Affective CogntiiveTraining in Postpartum Depression, Emotional Regulation and Cognitive Function 1, Social, sponsored by Mental Health Services in the Capital Region, Denmark. Recruiting at 1 site in Denmark. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Mental Health Services in the Capital Region, Denmark · Not applicable, Interventional, and Prevention
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.
Inclusion Criteria for General Pregnant Population:
Inclusion Criteria for High-Risk Pregnant Group:
Inclusion Criteria for Low-Risk Pregnant Group:
General Exclusion Criteria:
Receive the intervention
Other: Prenatal Affective CogntiiveTraining
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
A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation
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
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.
Time frame: Six months after birth
Infant development
Tertiary outcome involve assessing differences in infant development as measured with the Bayley Scales version 4 between the PACT and CAU groups
Time frame: Eight - eighteen months after birth
Mother-child interaction
Tertiary outcome involve assessing differences in mother-child interaction measures (e.g., sensitivity, intrusiveness, dyadic reciprocity and neural synchrony) between the PACT and CAU groups as measured with behavioural coding (Coding Interactive Behaviour) and fNIRS brain scan.
Time frame: Eight - eighteen months after birth
Change in affective cognition
Tertiary outcome involve assessing differences in the changes in facial expressions and visual attention towards infant stimuli (from T0 to T1 during pregnancy) between the PACT and CAU groups, as measured with computerized testing
Time frame: Third trimester of pregnancy
Plan to share: No
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Mental Health Services in the Capital Region, Denmark