Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT06046456
Status:
UNKNOWN
Last Update Posted:
2024-07-08
First Post:
2023-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Infant development', 'timeFrame': 'Eight - eighteen months after birth', 'description': 'Tertiary outcome involve assessing differences in infant development as measured with the Bayley Scales version 4 between the PACT and CAU groups'}, {'measure': 'Mother-child interaction', 'timeFrame': 'Eight - eighteen months after birth', 'description': '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.'}, {'measure': 'Change in affective cognition', 'timeFrame': 'Third trimester of pregnancy', 'description': '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'}], 'primaryOutcomes': [{'measure': '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)', 'timeFrame': 'Six months after birth', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Change in negative cognitive bias', 'timeFrame': 'In third trimester of pregnancy', 'description': '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'}, {'measure': 'Self-rated depressive symptoms', 'timeFrame': 'Within six weeks after birth', 'description': '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'}, {'measure': 'Self-rated parental stress', 'timeFrame': 'Six months after birth', 'description': 'Self-rated parental stress with the Parental Stress Scale at six months after birth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Depression', 'Emotional Regulation', 'Cognitive Function 1, Social', 'Pregnancy Related', 'Mother-Child Relations']}, 'referencesModule': {'references': [{'pmid': '39010232', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "Many pregnant women face the risk of experiencing depression after giving birth, especially if they've previously dealt with depression.\n\nThe 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.\n\nThis study has potential to offer a simple, non-invasive method to bolster mental health in expectant mothers, which could also positively impact their infants."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for General Pregnant Population:\n\n* Second or third trimester pregnancy.\n* Age ≥ 18 years.\n* Ability to speak and read Danish.\n\nInclusion Criteria for High-Risk Pregnant Group:\n\n* Either:\n* Negative cognitive bias in emotional reactivity to infant distress (cut-off \\> 96 on a scale from 0-100).\n* High-risk status according to the Antenatal Risk Questionnaire (ANRQ) which means:\n* Personal history of severe mental illness.\n* Experienced childhood emotional, physical, or sexual abuse.\n* Total score on psycho-social risk factors is above the cut-off (\\> 23).\n\nInclusion Criteria for Low-Risk Pregnant Group:\n\n* Absence of a personal or family history of mental illness.\n* Absence of negative bias.\n* Three or fewer of the additional risk factors mentioned above.\n\nGeneral Exclusion Criteria:\n\n* Schizophrenia.\n* Current substance use disorder.\n* Score of 9 or more on the Hamilton Depression Rating Scale-6 items (HDRS-6), indicating moderate depression.\n* 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).'}, 'identificationModule': {'nctId': 'NCT06046456', 'acronym': 'PACT', 'briefTitle': 'Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)', 'organization': {'class': 'OTHER', 'fullName': 'Mental Health Services in the Capital Region, Denmark'}, 'officialTitle': 'Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'R7-A182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PACT', 'description': 'Receive the intervention', 'interventionNames': ['Other: Prenatal Affective CogntiiveTraining']}, {'type': 'NO_INTERVENTION', 'label': 'CAU', 'description': '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'}], 'interventions': [{'name': 'Prenatal Affective CogntiiveTraining', 'type': 'OTHER', 'description': 'A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation', 'armGroupLabels': ['PACT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne J Bjertrup, PhD', 'role': 'CONTACT', 'email': 'anne.juul.bjertrup@regionh.dk', 'phone': '27134839'}], 'facility': 'Mental Health Services in The Capital Region of Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Anne J Bjertrup, PhD', 'role': 'CONTACT', 'email': 'anne.juul.bjertrup@regionh.dk', 'phone': '27134839'}, {'name': 'Anne Bjertrup', 'role': 'CONTACT', 'email': 'anne_bjertrup@hotmail.com', 'phone': '27134839'}], 'overallOfficials': [{'name': 'Kamill W Miskowiak, DMsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mental Health Services in the Capital Region of Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}