Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 4:46 PM
Study NCT ID:
NCT04264520
Status:
TERMINATED
Last Update Posted:
2024-10-24
First Post:
2020-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open Label Pilot Trial (no control group)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'PI changed institutions and was no longer able to continue project.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-08', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist for DSM-5 (PCL-5) Total Scores', 'timeFrame': "Baseline to follow-up (follow-up will occur at one-month following the baby's birth)", 'description': 'The PCL-5 is a 17-item self-report questionnaire designed to assess PTSD symptoms among civilians. In the current study, PCL-5 total scores will be utilized. Specifically, we will examine the impact of the intervention on change in PCL-5 scores across time (i.e., from baseline to post-delivery follow-up). Scores on the PCL-5 range from 0 to 80, with higher scores indicating more symptoms.'}, {'measure': "Baby's Weight at Birth in Pounds/Ounces", 'timeFrame': 'Baseline to birth of baby.', 'description': "Each baby's weight (in pounds/ounces) will be derived from the online medical record following delivery. This outcome will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and infant weight at birth."}, {'measure': 'Total Gestation Length in Weeks', 'timeFrame': 'Baseline to birth of baby.', 'description': "The total gestation length, in weeks, will be derived from the online medical record following the baby's birth. This outcome will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and total weeks gestation at birth."}, {'measure': "Baby's APGAR Score at Birth", 'timeFrame': 'Baseline to birth of baby.', 'description': "Each baby's APGAR score will be derived from the online medical record following delivery. APGAR scores range from 0-10, with higher scores indicating better health at birth for baby. APGAR scores will be used to determine the relationship between maternal PTSD symptoms (as indexed by the PCL-5 total scores--above) and infant health at birth."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perinatal Problems', 'Post Traumatic Stress Disorder', 'Post Partum Depression']}, 'descriptionModule': {'briefSummary': 'The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Intervention for pregnant women, so only women can be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years old\n* Fluent in English\n\nExclusion Criteria:\n\n* Active and severe domestic violence\n* Evidence of a significant mental illness or current substance use disorder that would impede the completion of the intervention\n* Suicidal individuals deemed at immediate danger or risk (i.e., requiring immediate hospitalization or treatment)\n* Women who smoke\n* Women who have a metabolic or endocrine disorder.'}, 'identificationModule': {'nctId': 'NCT04264520', 'briefTitle': 'Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women', 'orgStudyIdInfo': {'id': '00096405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTSD Psychoeducation + Skills Intervention', 'interventionNames': ['Behavioral: PTSD Psychoeducation + Skills Intervention']}], 'interventions': [{'name': 'PTSD Psychoeducation + Skills Intervention', 'type': 'BEHAVIORAL', 'description': 'A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.', 'armGroupLabels': ['PTSD Psychoeducation + Skills Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina Institute of Psychiatry', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'MUSC Specialized Center of Research Excellence', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}