Training for pregnant women to reduce postpartum depression risk

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

This study is testing a new training program for pregnant women to see if it can help lower the chances of developing postpartum depression, especially for those at higher risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Mental Health Services in the Capital Region, Denmark (Academic / other)
• Locations: 1 site (Copenhagen)
• Trial ID: NCT06046456 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a new intervention called Prenatal Affective Cognitive Training (PACT) in reducing the risk of postpartum depression among pregnant women, particularly those identified as high-risk due to previous mental health issues or psychosocial factors. A total of 226 pregnant women will participate, with high-risk individuals divided into two groups: one receiving the PACT training, which includes computer and virtual reality exercises over five weeks, and the other receiving usual care. Additionally, a low-risk group of 146 women will be monitored for comparison. The primary goal is to determine if the PACT intervention leads to lower rates of postpartum depression compared to standard care.

Who should consider this trial

Good fit: Ideal candidates include pregnant women in their second or third trimester who are either high-risk due to past mental illness or psychosocial factors or low-risk with no history of mental illness.

Not a fit: Patients with severe mental illnesses such as schizophrenia or those currently experiencing moderate depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the incidence of postpartum depression in high-risk pregnant women.

How similar studies have performed: Other studies have shown promise in using cognitive training approaches for mental health interventions, suggesting potential success for this novel approach.

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).

Where this trial is running

Copenhagen

• Mental Health Services in The Capital Region of Denmark — Copenhagen, Denmark (Recruiting)

Study contacts

• Principal investigator: Kamill W Miskowiak, DMsc — Mental Health Services in the Capital Region of Denmark
• Study coordinator: Anne J Bjertrup, PhD

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