Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 6:00 AM
Study NCT ID:
NCT07387692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer Support for Whole Health for Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-01-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inventory of Psychosocial Functioning', 'timeFrame': '9 months', 'description': 'The Inventory of Psychosocial Functioning measures all key areas of psychosocial functioning including social functioning (e.g., family, parenting, romantic relationships, friendships), vocational functioning (e.g., work and school), and self-care (e.g., chores, diet, medical care).'}], 'secondaryOutcomes': [{'measure': 'Well-Being Signs', 'timeFrame': '9 months', 'description': 'The Well-Being Signs assess satisfaction, involvement, and functioning in important aspects of life.'}, {'measure': 'Depression Anxiety and Stress Scales (DASS-21)', 'timeFrame': '9 months', 'description': 'The Depression Anxiety and Stress Scales-21 assess psychological distress including anxiety, depression, and stress-related symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychosocial Functioning', 'Mental Health']}, 'descriptionModule': {'briefSummary': 'This project is evaluating a new intervention, Peer Support for Whole Health. Peer Support for Whole Health is delivered by peer support specialists, Veterans who are in recovery from mental health or substance use concerns who are employed to help other Veterans. Peer Support for Whole Health uses the Whole Health model to talk about values and self-care in all areas of life. Peer Support for Whole Health is designed to help Veterans who have difficulty with their relationships, work, or day-to-day life and may have behavioral health concerns. Peer Support for Whole Health is designed for Veterans in primary care who are not engaged in mental health or substance use treatment. The goal of this study is to find out whether Peer Support for Whole Health helps Veterans with relationships, work, or day-to-day life. This project will also study whether Peer Support for Whole Health improves well-being and mental health. Finally, this study will seek to understand how Peer Support for Whole Health works and which Veterans it helps the most.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans\n* enrolled in primary care at one of the study sites\n* have some challenges with day-to-day life (e.g., relationships, work, school, getting things done) based on a standard questionnaire\n* have a recent primary care medical record note documenting potential behavioral health concerns or symptoms\n* fully understand the research study\n\nExclusion Criteria:\n\n* not be enrolled in current peer support services, mental health services, or other similar services\n* at risk for suicide or other high-risk concerns'}, 'identificationModule': {'nctId': 'NCT07387692', 'briefTitle': 'Peer Support for Whole Health for Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Randomized Controlled Trial of Peer Support for Whole Health', 'orgStudyIdInfo': {'id': 'RRD4-011-25M'}, 'secondaryIdInfos': [{'id': '1I01RD000397-01A', 'type': 'OTHER_GRANT', 'domain': 'VA ORD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer Support for Whole Health', 'description': 'In this arm, Veteran participants will receive Peer Support for Whole Health from VA peer support staff.', 'interventionNames': ['Behavioral: Peer Support for Whole Health']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-Directed Whole Health', 'description': 'In this arm, Veteran participants will receive information about Whole Health tools and resources from research staff.', 'interventionNames': ['Behavioral: Self-Directed Whole Health']}], 'interventions': [{'name': 'Peer Support for Whole Health', 'type': 'BEHAVIORAL', 'description': 'Veteran participants have one-on-one appointments with VA peer support staff to talk about VA Whole Health including goals and progress.', 'armGroupLabels': ['Peer Support for Whole Health']}, {'name': 'Self-Directed Whole Health', 'type': 'BEHAVIORAL', 'description': 'Veteran participants have an appointment with research staff and receive information about VA Whole Health tools and resources including handouts, websites, and apps.', 'armGroupLabels': ['Self-Directed Whole Health']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210-2716', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Emily M Johnson, PhD', 'role': 'CONTACT', 'email': 'emily.johnson1@va.gov', 'phone': '315-425-4400', 'phoneExt': '53487'}, {'name': 'Emily M. Johnson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Syracuse VA Medical Center, Syracuse, NY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '77030-4211', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Derrecka Boykin, PhD', 'role': 'CONTACT', 'email': 'Derrecka.Boykin@va.gov'}], 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Emily M Johnson, PhD', 'role': 'CONTACT', 'email': 'emily.johnson1@va.gov', 'phone': '(315) 425-4400', 'phoneExt': '53487'}], 'overallOfficials': [{'name': 'Emily M. Johnson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Syracuse VA Medical Center, Syracuse, NY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymous, de-identified data can be made available upon reasonable written request following conclusion of the trial. All identifiable information will be removed prior to sharing, and the minimum amount of data required to achieve the purposes of the request will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}