Clinical trial NCT06046456: Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
Official title: Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Emotional Regulation
Cognitive Function 1, Social
Pregnancy Related
Mother-Child Relations
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2023-09-21
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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).

Primary outcomes:
measure: 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)
timeFrame: Six months after birth
Secondary outcomes:
measure: Change in negative cognitive bias
timeFrame: In third trimester of pregnancy
measure: Self-rated depressive symptoms
timeFrame: Within six weeks after birth
measure: Self-rated parental stress
timeFrame: Six months after birth
Other outcomes:
measure: Infant development
timeFrame: Eight - eighteen months after birth
measure: Mother-child interaction
timeFrame: Eight - eighteen months after birth
measure: Change in affective cognition
timeFrame: Third trimester of pregnancy
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Services in The Capital Region of Denmark
Study officials:
affiliation: Mental Health Services in the Capital Region of Denmark
name: Kamill W Miskowiak, DMsc
role: PRINCIPAL_INVESTIGATOR
References: