Status:
UNKNOWN
Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Collaborating Sponsors:
University of Copenhagen
Conditions:
Postpartum Depression
Emotional Regulation
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 Pren...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
January 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06046456
Start Date
January 10 2023
End Date
July 1 2025
Last Update
July 8 2024
Active Locations (1)
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1
Mental Health Services in The Capital Region of Denmark
Copenhagen, Denmark, 2000