Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT06046456
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).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06046456
Study Brief:
Protocol Section:
NCT06046456