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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression; Pregnancy Related; Mother-Child Relations; Emotional Regulation; Cognitive Function 1, Social
• Intervention / Treatment: Other: Prenatal Affective CogntiiveTraining

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne J Bjertrup, PhD; Phone Number: 27134839; Email: anne.juul.bjertrup@regionh.dk
• Study Contact Backup: Name: Anne Bjertrup; Phone Number: 27134839; Email: anne_bjertrup@hotmail.com

Study Locations

• Denmark
  • Copenhagen, Denmark, 2000
    • Recruiting
    • Mental Health Services in the Capital Region of Denmark
    • Contact: Anne J Bjertrup, PhD; Phone Number: 27134839; Email: anne.juul.bjertrup@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PACT; Receive the intervention	Other: Prenatal Affective CogntiiveTraining; A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation
No Intervention: CAU; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Six months after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Within six weeks after birth
Self-rated parental stress	Self-rated parental stress with the Parental Stress Scale at six months after birth.	Six months after birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant development	Tertiary outcome involve assessing differences in infant development as measured with the Bayley Scales version 4 between the PACT and CAU groups	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.	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	Third trimester of pregnancy

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Kamill W Miskowiak, DMsc, Mental Health Services in the Capital Region of Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: R7-A182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No