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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06046456
Other study ID # R7-A182
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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
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