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

Not Applicable

Recruiting

• Conditions: Mother-Child Relations; Emotional Regulation; Pregnancy Related; Cognitive Function 1, Social; Postpartum Depression
• Interventions: Other: Prenatal Affective CogntiiveTraining

• Registration Number: NCT06046456
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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

Not available

Study Timeline

• Study Start: 2023-01-10
• Status Verified: 2023-08
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-02
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PACT	Prenatal Affective CogntiiveTraining	Receive the intervention

Primary Outcome Measures

Name	Time	Method
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)	Six months after birth	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)

Secondary Outcome Measures

Name	Time	Method
Change in negative cognitive bias	In third trimester of pregnancy	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
Self-rated depressive symptoms	Within six weeks after birth	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
Self-rated parental stress	Six months after birth	Self-rated parental stress with the Parental Stress Scale at six months after birth.

Trial Locations

Locations (1)

Mental Health Services in The Capital Region of Denmark; 🇩🇰 Copenhagen, Denmark