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

Pregnancy Related Clinical Trial

— PACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046456
• Other study ID #: R7-A182
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Anne J Bjertrup, PhD
• Phone: 27134839
• Email: anne.juul.bjertrup[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Function 1, Social
• Depression
• Depression, Postpartum
• Depressive Disorder
• Emotional Regulation
• Mother-Child Relations
• Postpartum Depression
• Pregnancy Related

Intervention

Other:
• Prenatal Affective CogntiiveTraining
A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation

Locations

Country	Name	City	State
Denmark	Mental Health Services in The Capital Region of Denmark	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mother-infant measures	Tertiary outcomes involve assessing differences in infant development, mother-infant interaction measures (e.g., sensitivity, intrusiveness, dyadic reciprocity), and changes in facial expressions and visual attention towards infant stimuli (during pregnancy) between the PACT and CAU groups.	Ten months
Primary	Post partum depression	Occurence of depression and depression severity during the first six months after birth	Six months
Secondary	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