Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04056767
Status:
UNKNOWN
Last Update Posted:
2019-08-14
First Post:
2019-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Digital Phenotype During PE Therapy
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Heart Rate', 'timeFrame': '3 months', 'description': 'Heart Rate and HRV (Heart Rate Variability)'}, {'measure': 'Changes in Saturation', 'timeFrame': '3 months', 'description': 'Changes in saturation SPO2 (oxygen saturation by pulse oximetry)'}, {'measure': 'Changes in blood pressure', 'timeFrame': '3 months', 'description': 'Changes in Continuous Blood Pressure'}, {'measure': 'Changes in Pulse Pressure', 'timeFrame': '3 months', 'description': 'Changes in Pulse Pressure'}, {'measure': 'Changes in Respiratory rate', 'timeFrame': '3 months', 'description': 'Changes in Respiratory rate'}, {'measure': 'Changes in Stroke Volume', 'timeFrame': '3 months', 'description': 'Changes in Stroke Volume'}, {'measure': 'Changes in Systemic Vascular Resistance', 'timeFrame': '3 months', 'description': 'Changes in Systemic Vascular Resistance'}, {'measure': 'Changes in sweat', 'timeFrame': '3 months', 'description': 'Changes in Sweat'}, {'measure': 'Changes in Body Temperature', 'timeFrame': '3 months', 'description': 'Changes in Body Temperature'}, {'measure': 'Changes in Cardiac Output', 'timeFrame': '3 months', 'description': 'Changes in Cardiac Output'}], 'secondaryOutcomes': [{'measure': 'Correlation between changes in digital phenotype (multiple measures)', 'timeFrame': '3 months', 'description': 'Correlation between changes in digital phenotype during the sessions and the clinical improvement according to the psychiatric evaluation and questionnaires.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'PTSD is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. Prolonged Exposure (PE) therapy is a widely used protocol considered highly affective among individuals diagnosed with PTSD.\n\nThe current study is a non-interventional observational study, aimed at measuring changes in the digital phenotype of participants with PTSD during and following PE therapy. Physiological data will be collected using wearable sensors during the sessions, and participants will be assessed using questionnaires and psychiatric assessments before and after the completion of their imaginal or writing based PE therapy (10-15 sessions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (aged 18 and over) participants diagnosed with PTSD and undergoing PE therapy; 50 using imaginal PE and 50 using writing PE.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD diagnosis\n* Proper ability to give informed consent\n\nExclusion Criteria:\n\n* Active psychotic or suicidal symptoms\n* Severe dissociative symptoms\n* A traumatic brain injury (TBI) diagnosis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04056767', 'briefTitle': 'Changes in Digital Phenotype During PE Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The Chaim Sheba Medical Center'}, 'officialTitle': 'Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch', 'orgStudyIdInfo': {'id': '6269-19-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Imaginal PE'}, {'label': 'Writing PE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nadav Goldental', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nadav Goldental', 'investigatorAffiliation': 'The Chaim Sheba Medical Center'}}}}