Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-26 @ 10:47 PM
Study NCT ID:
NCT04992767
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2021-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist for DSM-5 (PCL-5)', 'timeFrame': 'Past 30 days', 'description': "The PCL-5 is a well validated screening tool for assessing PTSD symptoms and probable PTSD diagnosis. the PCL-5 checklist assesses frequency of past 30-day PTSD symptoms in reference to an individual's self-identified worst traumatic event. A total score of 33 or greater represents a positive PTSD screen and is the cut-off employed in the current study."}, {'measure': 'Impact of Events Scale - Revised (IES-R)', 'timeFrame': '1 week', 'description': "The IES-R assesses the past-week frequency of PTSD symptoms in reference to the participant's self-identified worst traumatic event"}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': '2 weeks', 'description': 'Reflects overall functioning and impairment due to the depressive symptoms. PHQ-9 scoring interpretations are as follows: 1-4: minimal depressive symptoms; 5-9 mild depressive symptoms; 10-14: moderate depressive symptoms; 15-19: moderately severe depressive symptoms: 20-27: severe depressive symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posttraumatic Stress Disorder', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'The investigators will design, construct, and pilot a prototype of a trauma-informed online intervention, which will be called "SunnysideFlex," that functionally integrates a web-based intervention targeting skills to decrease symptoms of PTSD and better manage mood during and after pregnancy. SunnysideFlex will build upon the previously IRB-approved "Sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. Women in weeks 16-28 of their pregnancy who self-report symptoms of PTSD will be randomized to one of three study groups: (1) SunnysideFlex, (2) the original Sunnyside intervention (active control), or (3) treatment as usual (TAU). The SunnysideFlex intervention will consist of 6 weeks of trauma-informed online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Outcomes will be measured at baseline, post-intervention, 6 weeks postpartum, and 12 weeks postpartum. SunnysideFlex has the potential to provide a novel paradigm for improving maternal and child health outcomes in high-risk, trauma-exposed women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 18 years and older\n* Pregnant and between 16-28 weeks gestation\n* Are currently engaged in prenatal care with a healthcare provider (OB/GYN, nurse, midwife, etc.)\n* Endorse a history of one or more potentially traumatic events meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Criterion A for PTSD (i.e., "exposure to actual or threatened death, serious injury, or sexual violence," American Psychological Association \\[APA\\], p. 271) that is interpersonal in nature (e.g., sexual or physical assault, child abuse/maltreatment, witnessing family violence)\n* Endorse a score of 33 or greater on the PTSD Checklist for DSM-5 (PCL-5)\n* Have access to a broadband internet connection\n* Able to read and speak English\n\nExclusion Criteria:\n\n* Pregnant with multiples\n* Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures\n* Have been diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous based on self-report\n* Report currently being in an abusive or unsafe relationship\n* Currently receiving treatment (medication or psychotherapy), or have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy)'}, 'identificationModule': {'nctId': 'NCT04992767', 'briefTitle': 'Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy', 'orgStudyIdInfo': {'id': '2021-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sunnyside', 'description': 'An online intervention to better manage mood during and after pregnancy.', 'interventionNames': ['Behavioral: Sunnyside']}, {'type': 'EXPERIMENTAL', 'label': 'SunnysideFlex', 'description': 'An online intervention to treat symptoms of PTSD and better manage mood during and after pregnancy.', 'interventionNames': ['Behavioral: SunnysideFlex']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'A control condition consisting of standard prenatal medical care, without provision of the SunnysideFlex or Sunnyside intervention'}], 'interventions': [{'name': 'Sunnyside', 'type': 'BEHAVIORAL', 'description': 'The Sunnyside intervention is an online intervention(an interactive website with didactic material and interactive tools) targeting skills to manage mood during and after pregnancy. The Sunnyside intervention will consist of 6 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Each lesson takes approximately 10 minutes to complete.', 'armGroupLabels': ['Sunnyside']}, {'name': 'SunnysideFlex', 'type': 'BEHAVIORAL', 'description': 'SunnysideFlex consists of 6 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. SunnysideFlex has adapted the original Sunnyside intervention with revised, trauma-focused content that covers the impact of PTSD symptoms on the perinatal period and daily functioning, more broadly', 'armGroupLabels': ['SunnysideFlex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Department of Psychology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jennifer Duffecy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jennifer Duffecy', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}