Viewing Study NCT06046456


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Ignite Modification Date: 2025-12-25 @ 9:24 PM
Study NCT ID: NCT06046456
Status: UNKNOWN
Last Update Posted: 2024-07-08
First Post: 2023-09-14
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
Sponsor: Mental Health Services in the Capital Region, Denmark
Organization:

Study Overview

Official Title: Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial
Status: UNKNOWN
Status Verified Date: 2023-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PACT
Brief 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 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: