Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-02 @ 11:14 AM
Study NCT ID:
NCT03337750
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2017-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003130', 'term': 'Combat Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2017-11-03', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD CheckList-5 (PCL-5)', 'timeFrame': 'Change from baseline to 1-month follow-up (post-treatment)', 'description': 'A 20-item self-report measure of PTSD symptoms as defined by the DSM-5. Higher scores indicate greater PTSD symptom severity.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Change from baseline to 1-month follow-up (post-treatment)', 'description': 'A 9-item measure of the severity of depressive symptoms. Higher scores indicated greater depressive symptom severity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Combat', 'Psychological Treatment', 'Military', 'Psychotherapy', 'Trauma', 'Posttraumatic Stress', 'Posttraumatic Stress Disorder'], 'conditions': ['Posttraumatic Stress Disorder', 'Combat Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://studypages.com/s/are-you-a-veteran-or-service-member-dealing-with-posttraumatic-stress-participate-in-a-web-based-treatment-study-357599/', 'label': 'Study enrollment page'}, {'url': 'https://tango.uthscsa.edu/strongstar/', 'label': 'STRONG STAR consortium'}]}, 'descriptionModule': {'briefSummary': 'It is urgent to make evidence-based treatments (EBTs) for military personnel readily accessible in order to meet the growing demand for effective and efficient treatment for posttraumatic stress disorder (PTSD) in a timely manner. Effective EBTs for PTSD are available, but barriers to accessing care can deter military personnel from receiving treatment. Web-treatments represent an innovative way to overcome these barriers. The efficacy of previously developed web-treatments for PTSD appear promising, however, they are not based on treatment protocols with strong empirical support for their efficacy. No study to date has examined web-treatment of PTSD using a well-established treatment program.\n\nThe purpose of this open trial is to examine the efficacy of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks in 40 active-duty military personnel and veterans with PTSD who deployed post 9-11. Up to 60 individuals will be consented to obtain data from 40 for analysis. Participants will be assessed at pre-treatment and 1- and 3-months after treatment completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active-duty military personnel and veterans who have deployed post 9/11\n* Seeking treatment for PTSD\n* Significant PTSD symptoms as determined by a PCL-5 score greater than or equal to 31\n* Has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a period of recent military deployment\n* Able to speak and read English and access to an internet-connected computer\n* Indication that the participant plans to be able to participant in the study for the next three months following the first assessment\n\nExclusion Criteria:\n\n* Diagnosis of bipolar disorder or psychotic disorder, as determined by participant self-report)\n* Current substance dependence, as determined by participant self-report)\n* Diagnosis of a moderate or severe traumatic brain injury, as determined by participant self-report)\n* Current suicidal ideation severe enough to warrant immediate attention, as determined by participant self-report)\n* Currently engaged in evidence-based treatment for PTSD (e.g. Prolonged Exposure Therapy or Cognitive Processing Therapy), as determined by participant self-report.'}, 'identificationModule': {'nctId': 'NCT03337750', 'briefTitle': 'An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military', 'orgStudyIdInfo': {'id': 'HSC20170600H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Web-PE', 'description': 'Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).', 'interventionNames': ['Behavioral: Web-PE Therapy']}], 'interventions': [{'name': 'Web-PE Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Internet-based prolonged exposure'], 'description': 'Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).', 'armGroupLabels': ['Web-PE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center for the Treatment and Study of Anxiety, University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'VA Palo Alto Health Care System', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Assistant Professor', 'investigatorFullName': 'Carmen McLean', 'investigatorAffiliation': 'University of Pennsylvania'}}}}