Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-29 @ 12:03 AM
Study NCT ID:
NCT02956902
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
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': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2016-11-03', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PTSD symptom severity', 'timeFrame': '8 weeks', 'description': 'Change in PTSD checklist (PCL-5) score'}], 'secondaryOutcomes': [{'measure': 'Clinically significant change in PTSD symptom severity', 'timeFrame': '8 weeks', 'description': 'Proportion of participants with a PCL-5 score less than 31'}, {'measure': 'Change in Depression Severity', 'timeFrame': '8 week', 'description': 'Change in patient health questionnaire 9 (PHQ-9) score'}, {'measure': 'Average App Use per Week (Intervention group only)', 'timeFrame': '8 weeks', 'description': 'Self-report app use will be collected by the clinician at each of sessions 2-4 by asking "on average, how many times did you use the app per day (or per week, if less than once per day). The clinician will also ask which of the four main functions were used and which symptom management tools were used most and were most helpful.'}, {'measure': 'Goal Achievement (Intervention group only)', 'timeFrame': '8 weeks', 'description': 'At each of sessions 1-3, the clinician will help the participant set goals, which will be documented. At each of sessions 2-4 the clinician will ask the participant to self-report goal achievement, which will be documented'}, {'measure': 'Clinician Fidelity to Protocol', 'timeFrame': '8 weeks', 'description': 'A fidelity checklist has been created for this protocol, which will be completed over the course of the intervention. The form will be updated upon completion of each clinician session.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['PostTraumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This study tests whether people receiving clinician support to use a mobile application on their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than those who do not. Half of the participants will receive the clinician supported smartphone application intervention and the other half will remain on the waiting list.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* on the waiting list for the Ontario Shores traumatic stress clinic;\n* score ≥ 31 on the PCL-5\n* have access to a smartphone or tablet to which they are willing to download the app.\n\nExclusion Criteria:\n\n* active suicidal ideation'}, 'identificationModule': {'nctId': 'NCT02956902', 'briefTitle': 'A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ontario Shores Centre for Mental Health Sciences'}, 'officialTitle': 'A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial', 'orgStudyIdInfo': {'id': '16-107IF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Waiting list control'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Clinician-supported smartphone application intervention', 'interventionNames': ['Other: Clinician supported smartphone application intervention']}], 'interventions': [{'name': 'Clinician supported smartphone application intervention', 'type': 'OTHER', 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ontario Shores Centre for Mental Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}