Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04390451
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2020-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Initial Testing of Whole Health STEPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-24', 'size': 331627, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-16T11:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study compares Whole Health STEPS to a waitlist control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inventory of Psychosocial Functioning (IPF)', 'timeFrame': '4 months', 'description': 'This 80 item self-report inventory measures several domains of psychosocial functioning (e.g., family relationships, work, self-care) on a 0-100 scale with lower scores indicating better outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Health Care', 'Mental Health'], 'conditions': ['Mental Health']}, 'descriptionModule': {'briefSummary': "This clinical trial is evaluating Whole Health STEPS (Structured Tiered Engagement with Peer Support), a package of services designed to improve functional outcomes for primary care Veterans with mental health concerns who are not actively engaged in mental health services. Whole Health STEPS uses a Peer Support Specialist, or Peer, to provide support for Veterans to make progress on wellness goals using the Whole Health model. The level of support provided will be determined based on Veterans' progress and will be stepped-up until Veterans receive the level of support they need. Whole Health STEPS offers a non-mental health referral option for primary care Veterans with mental health concerns, provides a structured package of existing Whole Health services, and provides a structured service for peers in primary care settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran status\n* Enrolled in primary care at a participating site\n* Have at least mild functional impairment\n* Screen positive on at least one primary care mental health screener\n\nExclusion Criteria:\n\n* Actively engaged with an equivalent or higher level of care\n* Preference for direct referral to mental health care\n* Recent changes to psychotropic medications\n* Severe impairment preventing engagement in the intervention or warranting a direct referral to a licensed independent provider\n* Inability to independently communicate in verbal and written English\n* Inability to complete the research tasks or intervention'}, 'identificationModule': {'nctId': 'NCT04390451', 'briefTitle': 'Initial Testing of Whole Health STEPS', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Initial Testing of Whole Health STEPS (Structured Tiered Engagement With Peer Support)', 'orgStudyIdInfo': {'id': 'D3390-W'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole Health STEPS', 'description': 'Participants will immediately receive Whole Health STEPS.', 'interventionNames': ['Behavioral: Whole Health STEPS']}, {'type': 'OTHER', 'label': 'Waitlist', 'description': 'Participants will receive Whole Health STEPS after a defined waiting period.', 'interventionNames': ['Behavioral: Whole Health STEPS']}], 'interventions': [{'name': 'Whole Health STEPS', 'type': 'BEHAVIORAL', 'otherNames': ['Whole Health Structured Tiered Engagement with Peer Support'], 'description': 'A peer-delivered package of Whole Health services.', 'armGroupLabels': ['Waitlist', 'Whole Health STEPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210-2716', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Syracuse VA Medical Center, Syracuse, NY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'overallOfficials': [{'name': 'Emily M. Johnson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Syracuse VA Medical Center, Syracuse, NY'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'The dataset will be available following publication of the primary manuscript for this project.', 'ipdSharing': 'YES', 'description': 'A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.', 'accessCriteria': 'The dataset will be released upon written request for scientific purposes including re-analysis and validation of results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}