Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT05534100
Status:
TERMINATED
Last Update Posted:
2023-10-18
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Trial discontinued due to unreliable wearable device.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale for DSM-5', 'timeFrame': 'Through study completion, average of 1 month', 'description': 'Clinician administered measure of PTSD'}, {'measure': 'PTSD Checklist for DSM-5 Criteria', 'timeFrame': 'Through study completion, average of 1 month', 'description': 'Self-report measure of PTSD'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posttraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': "The aim of the project is to advance our understanding of how individuals with Posttraumatic Stress Disorder (PTSD) experience symptoms in their every-day lives when they are in their home environment. To date, all PTSD assessments are retrospective; individuals with PTSD are asked to recount and report their symptoms over the past weeks or months. Such assessment procedures are negatively impacted by individuals' abilities to accurately recall information. Moreover, retrospective assessments provide little information about how symptoms are experienced in the moment and how these experiences then lead to other behaviors. The proposed project addresses these limitations by assessing PTSD symptoms and associated biological markers (e.g., sleep, heart rate, heart rate variability) in real-time by asking subjects to wear a smart device and complete brief surveys. Data will be collected from 50 individuals with PTSD and 20 healthy controls to help us better understand individuals' real-time experience with PTSD and lay the foundation to develop algorithms for possible in-the-moment interventions in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who either present as a healthy control or are deemed to have PTSD by the CAPS', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for participants with PTSD: Individuals are eligible for the current study if they:\n\n1. Are 18 years or older\n2. Are fluent in English\n3. Have an active smart phone or smart device with full data and Bluetooth capability\n4. Have experienced a Criterion A traumatic event during their lifetime\n5. Have a PTSD diagnosis verified by the Clinician Administered PTSD Scale for DSM-5 and a symptom severity score of 35 or higher.\n6. Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study\n7. Are willing to wear a smart device 24/7 over the course of one month.\n\nExclusion Criteria for PTSD participants: Individuals are excluded from the current study if:\n\n1. The traumatic event occurred in the past month\n2. They are currently suicidal or homicidal\n3. They have a history of psychosis or mania\n4. They have a known, diagnosed heart condition\n5. They are currently receiving treatment for their PTSD or have completed an evidence- based PTSD treatment in the past 3 months\n6. They have a serious or unstable medical illness or instability for which hospitalization may be likely\n7. Subjects who, at the time of consent, appear to have extenuating life circumstances (unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect their ability to participate in the study\n\nInclusion Criteria for healthy controls:\n\nIndividuals are eligible for the current study if they:\n\n1. Are 18 years or older\n2. Are fluent in English\n3. Have an active smart phone or smart device with full data and Bluetooth capability\n4. Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study\n5. Are willing to wear a smart device 24/7 over the course of one month.\n\nExclusion Criteria for healthy controls:\n\nIndividuals are excluded from the current study if they:\n\n1. Score a 10 or higher on the Clinician Administered PTSD Scale for DSM-5\n2. Known or diagnosed heart condition\n3. Known or diagnosed psychiatric condition\n4. Currently or have previously received psychiatric care in the past 3 months\n5. Subjects who, at the time of consent, appear to have extenuating life circumstances (unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect their ability to participate in the trial'}, 'identificationModule': {'nctId': 'NCT05534100', 'briefTitle': 'Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': '21090706'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control', 'interventionNames': ['Device: Biostrap EVO Wristband']}, {'label': 'PTSD', 'interventionNames': ['Device: Biostrap EVO Wristband']}], 'interventions': [{'name': 'Biostrap EVO Wristband', 'type': 'DEVICE', 'description': 'Participants in both groups will wear the Biostrap wearable device', 'armGroupLabels': ['Healthy Control', 'PTSD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Philip Held', 'investigatorAffiliation': 'Rush University Medical Center'}}}}