Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
Launched by MENTAL HEALTH SERVICES IN THE CAPITAL REGION, DENMARK · Sep 14, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the Prenatal Affective Cognitive Training (PACT), is studying a new program aimed at reducing the risk of postpartum depression in pregnant women. The focus is on helping women who may have a higher chance of experiencing depression after giving birth, especially those with a history of mental health issues. The study involves 226 pregnant women classified as "high risk" due to their past experiences or mental health concerns. These women will be split into two groups: one will participate in a five-week training using computer and virtual reality exercises to improve their mood and emotional skills, while the other group will receive standard care. There is also a separate group of 146 low-risk pregnant women being monitored for comparison, but they won’t take part in the training.
To be eligible for this study, participants need to be in their second or third trimester of pregnancy, at least 18 years old, and able to read and speak Danish. High-risk women must meet specific criteria related to their mental health history or other risk factors, while low-risk women should have no personal or family history of mental illness. Participants can expect to engage in activities designed to enhance their emotional well-being, which could not only help them but also benefit their babies. This trial is currently recruiting participants and aims to provide a simple way to support the mental health of expectant mothers.
Gender
FEMALE
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).
About Mental Health Services In The Capital Region, Denmark
The Mental Health Services in the Capital Region of Denmark is a leading clinical trial sponsor dedicated to advancing psychiatric research and improving mental health care delivery. Operating within a robust healthcare framework, the organization focuses on innovative treatment methodologies and evidence-based practices, collaborating with multidisciplinary teams to conduct rigorous clinical trials. By prioritizing patient-centered outcomes and leveraging cutting-edge technology, the Mental Health Services aim to enhance therapeutic interventions and contribute to the global understanding of mental health disorders. Their commitment to research excellence fosters a culture of continuous improvement and collaboration, ultimately striving to elevate the standards of mental health services in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Patients applied
Trial Officials
Kamill W Miskowiak, DMsc
Principal Investigator
Mental Health Services in the Capital Region of Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported