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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACT | Experimental | Receive the intervention |
|
| CAU | No Intervention | Receive care as usual, i.e., the standard care provided to pregnant women without any additional experimental interventions. It typically involves routine prenatal care, which may include regular check-ups, medical assessments, and general support from healthcare professionals |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prenatal Affective CogntiiveTraining | Other | A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The primary outcome is the difference between mothers receiving PACT versus CAU in the incidence of PPD during the first six months after birth, assessed by a clinician blind to group status with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN) | Six months after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Change in negative cognitive bias | Differences between participants receiving PACT and CAU in the change in negatively biased cognitive processing of infant stimuli from baseline to follow-up during pregnancy (T1) as measured with computerized testing | In third trimester of pregnancy |
| Self-rated depressive symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Infant development | Tertiary outcome involve assessing differences in infant development as measured with the Bayley Scales version 4 between the PACT and CAU groups | Eight - eighteen months after birth |
| Mother-child interaction |
Inclusion Criteria for General Pregnant Population:
Inclusion Criteria for High-Risk Pregnant Group:
Inclusion Criteria for Low-Risk Pregnant Group:
General Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne J Bjertrup, PhD | Contact | 27134839 | anne.juul.bjertrup@regionh.dk | |
| Anne Bjertrup | Contact | 27134839 | anne_bjertrup@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kamill W Miskowiak, DMsc | Mental Health Services in the Capital Region of Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Services in The Capital Region of Denmark | Recruiting | Copenhagen | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39010232 | Derived | Bjertrup AJ, Kofoed J, Egmose I, Wendelboe K, Southgate V, Vaever MS, Miskowiak KW. Prenatal affective cognitive training to reduce the risk of postpartum depression (PACT): study protocol for a randomized controlled trial. Trials. 2024 Jul 15;25(1):478. doi: 10.1186/s13063-024-08316-1. |
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Differences between participants receiving PACT and CAU in severity of depressive symptoms during the first six weeks after birth measured with the Edinburgh Postpartum Depression Scale |
| Within six weeks after birth |
| Self-rated parental stress | Self-rated parental stress with the Parental Stress Scale at six months after birth. | Six months after birth |
Tertiary outcome involve assessing differences in mother-child interaction measures (e.g., sensitivity, intrusiveness, dyadic reciprocity and neural synchrony) between the PACT and CAU groups as measured with behavioural coding (Coding Interactive Behaviour) and fNIRS brain scan.
| Eight - eighteen months after birth |
| Change in affective cognition | Tertiary outcome involve assessing differences in the changes in facial expressions and visual attention towards infant stimuli (from T0 to T1 during pregnancy) between the PACT and CAU groups, as measured with computerized testing | Third trimester of pregnancy |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
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