Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:13 AM
Study NCT ID:
NCT07349368
Status:
COMPLETED
Last Update Posted:
2026-01-16
First Post:
2025-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Cost-effectiveness of Simultaneous Screening and Intervention for Antenatal Depression and Anxiety Symptoms From a Transdiagnostic Perspective: A Scale-up Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-11', 'studyFirstSubmitDate': '2025-12-07', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cost-effectiveness ratios (ICER)', 'timeFrame': 'at 42 days postpartum', 'description': 'ICER were calculated by dividing the difference in mean costs by the difference in anxiety and/or depression symptoms-free (Δcosts/Δoutcome). Cost included screening, access to the animated videos, and counselling.'}], 'primaryOutcomes': [{'measure': 'Edinburgh Postnatal Depression Scale (EPDS) Score', 'timeFrame': 'at 42 days postpartum', 'description': 'The EPDS is a 10-item self-report questionnaire. Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.'}, {'measure': 'Generalized Anxiety Disorder 7-item (GAD-7) Scale Score', 'timeFrame': 'at 42 days postpartum', 'description': 'The GAD-7 is a 7-item self-report questionnaire. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antenatal Depression', 'Antenatal Anxiety']}, 'descriptionModule': {'briefSummary': "This scale-up study aimed to explore the effectiveness of simultaneous screening and intervention of antenatal depression and anxiety in preventing postpartum depression and anxiety and how scale-up might be successfully achieved. The age was ≥18 years old pregnancy and capable of completing the independent assessment of smart phones. Exclude those with abnormal comprehension and expression abilities. The implementation group, 1. screening during pregnancy and 42 days postpartum; 2. Stratified iCBT Intervention, usual care. Low-intensity: Mild cases (EPDS≥9/GAD-7≥5) received 11 animated video sessions adapted from WHO's Thinking Healthy Programme manual. High-intensity: Moderate-severe cases (EPDS≥12/GAD-7≥10) received low-intensity components and supplemental telehealth counseling. The control group, screening at 42 days postpartum, usual care."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age was ≥18 years old pregnancy and capable of completing the independent assessment of smart phones.\n\nExclusion Criteria:\n\n* Exclude those with abnormal comprehension and expression abilities'}, 'identificationModule': {'nctId': 'NCT07349368', 'briefTitle': 'Effectiveness and Cost-effectiveness of Simultaneous Screening and Intervention for Antenatal Depression and Anxiety Symptoms From a Transdiagnostic Perspective: A Scale-up Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Anhui Medical University'}, 'officialTitle': 'Effectiveness and Cost-effectiveness of Simultaneous Screening and Intervention for Antenatal Depression and Anxiety Symptoms From a Transdiagnostic Perspective: A Scale-up Feasibility Study', 'orgStudyIdInfo': {'id': '20170358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual care group', 'description': 'no additional intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Stratified iCBT group', 'description': 'Stratified iCBT(Internet-based Cognitive Behavioral Therapy) Intervention plus usual care', 'interventionNames': ['Behavioral: implementation group']}], 'interventions': [{'name': 'implementation group', 'type': 'BEHAVIORAL', 'description': "1. screening during pregnancy and 42 days postpartum\n2. Stratified iCBT Intervention, usual care Low-intensity: Mild cases (EPDS≥9/GAD-7≥5) received 11 animated video sessions adapted from WHO's Thinking Healthy Programme manual. High-intensity: Moderate-severe cases (EPDS≥12/GAD-7≥10) received low-intensity components and supplemental telehealth counseling.", 'armGroupLabels': ['Stratified iCBT group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuyang', 'country': 'China', 'facility': 'Jieshou Maternal and Child Health Hospital', 'geoPoint': {'lat': 32.9, 'lon': 115.81667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study does not currently plan to share individual participant data (IPD). The main reasons are: ① The study involves sensitive clinical information (e.g., scores from mental health scales), and there remains potential privacy risks even after de-identification; ② The data usage agreement does not include authorization for external sharing, and additional informed consent from study participants is required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fangbiao Tao', 'investigatorAffiliation': 'Anhui Medical University'}}}}