Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-01 @ 2:45 AM
Study NCT ID:
NCT02486705
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2015-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver Burden (Montgomery Burden Interview)', 'timeFrame': '1 month'}, {'measure': 'Stress (Perceived Stress Scale)', 'timeFrame': '1 month'}, {'measure': 'Use of PTSD Family Coach Mobile App (Study-Specific Survey)', 'timeFrame': '1 month'}, {'measure': 'Satisfaction with PTSD Family Coach Mobile App (Study-Specific Survey)', 'timeFrame': '1 month'}, {'measure': 'Depression (PHQ-8)', 'timeFrame': '1 month'}, {'measure': 'Anxiety (GAD)', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Stigma Associated with Seeking Mental Health Care (Study-Specific Measure)', 'timeFrame': '1 month'}, {'measure': 'Perceived Benefits of Mental Health Treatment for PTSD (Study-Specific Measure)', 'timeFrame': '1 month'}, {'measure': 'Social Constraints (Social Constraints Scale)', 'timeFrame': '1 month'}, {'measure': 'Partner Self-Efficacy (Study-Specific Measure)', 'timeFrame': '1 month'}, {'measure': 'Veteran Interest in Treatment for PTSD (Study-Specific Measure)', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ptsd', 'family', 'caregiver', 'burden'], 'conditions': ['Stress Disorders, Post-Traumatic']}, 'referencesModule': {'references': [{'pmid': '36602852', 'type': 'DERIVED', 'citation': 'van Stolk-Cooke K, Wielgosz J, Hallenbeck HW, Chang A, Rosen C, Owen J, Kuhn E. The PTSD Family Coach App in Veteran Family Members: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Jan 5;7:e42053. doi: 10.2196/42053.'}]}, 'descriptionModule': {'briefSummary': "The proposed pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder (PTSD). The primary objective of the proposed study is to assess whether family members of veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use. Secondary objectives are to determine if use of the app increases family members' self-efficacy and their ability to manage their own life stress, which may in part be the result of living with someone who has PTSD.", 'detailedDescription': "PTSD Family Coach is a mobile phone app for family members of individuals with PTSD. This application provides:\n\n* education about PTSD\n* a self-assessment tool measuring life stress\n* self-management skills to address acute distress and stress\n* direct connection to support and\n* information about VA and community resources for family members of individuals with PTSD\n\nFrom this research, the investigators wish to learn whether family members of someone with PTSD find the PTSD Family Coach to be satisfactory and feasible to use. The investigators would also like to know if use of the app increases family members' knowledge of PTSD, and its treatment, and their ability to manage their own life stress, which may in part be the result of living with a Veteran with PTSD.\n\nCurrently, there are very few resources for family members of Veterans with PTSD. If this research demonstrates that PTSD Family Coach is a promising tool for family members, it has the potential to address a tremendous unmet need using a very cost-effective, scalable solution."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* currently living with a Veteran with significant PTSD symptoms\n* age 18 or older\n* own an iPhone, iPad or other iOS compatible device\n* currently experiencing at least moderate symptoms of stress\n\nExclusion Criteria:\n\n* currently enrolled in another study related to PTSD'}, 'identificationModule': {'nctId': 'NCT02486705', 'briefTitle': 'Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD', 'organization': {'class': 'FED', 'fullName': 'VA Palo Alto Health Care System'}, 'officialTitle': 'Pilot Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD', 'orgStudyIdInfo': {'id': '28147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PTSD Family Coach Basic', 'description': 'PTSD Coach basic provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD and additional support resources.', 'interventionNames': ['Behavioral: PTSD Family Coach Basic']}, {'type': 'EXPERIMENTAL', 'label': 'PTSD Family Coach Full', 'description': 'PTSD Family Coach full provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD, additional support resources, tools for coping with caregiving-related stress, and tools for self-monitoring stress symptoms.', 'interventionNames': ['Behavioral: PTSD Family Coach Full']}], 'interventions': [{'name': 'PTSD Family Coach Full', 'type': 'BEHAVIORAL', 'otherNames': ['PTSD Family Coach app- full version'], 'description': 'PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information, support resources, tools for coping with caregiver-related stress, and tools for self-monitoring stress symptoms.', 'armGroupLabels': ['PTSD Family Coach Full']}, {'name': 'PTSD Family Coach Basic', 'type': 'BEHAVIORAL', 'otherNames': ['PTSD Family Coach app- basic version'], 'description': 'PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,', 'armGroupLabels': ['PTSD Family Coach Basic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Palo Alto Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist', 'investigatorFullName': 'Jason Owen', 'investigatorAffiliation': 'VA Palo Alto Health Care System'}}}}