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

Mental Health Services in the Capital Region, Denmark

Status: Enrolling

Conditions: Mother-Child Relations; Pregnancy Related; Emotional Regulation; Cognitive Function 1, Social; Postpartum Depression

Treatments: Other: Prenatal Affective CogntiiveTraining

Study type: Interventional

Funder types: Other

Identifiers

NCT06046456

R7-A182

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

PACT

Experimental group

Description:

Receive the intervention

Treatment:

Other: Prenatal Affective CogntiiveTraining

CAU

No Intervention group

Description:

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