Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT04896151
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2021-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Utility of MMPI-2-RF-EX in Detecting Simulated Underreporting of Current Suicide Risk in Military Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-25', 'size': 268763, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-01T21:21', 'hasProtocol': True}, {'date': '2021-02-25', 'size': 183066, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-01T21:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2021-05-01', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Short Grit Scale', 'timeFrame': 'Baseline', 'description': 'The Short Grit Scale is an 8-item measure of trait-level perseverance and passion for long-term goals. Possible scores range from 5 to 40, with higher scores indicting higher levels of grit.'}, {'measure': 'MMPI Posttest Inquiry (PTI)', 'timeFrame': 'Baseline', 'description': "The PTI assesses participants' compliance with condition-specific instructions for completing the MMPI and was adapted for the proposed research"}, {'measure': 'PTSD Checklist for DSM-5 (PCL-5) PTSD Checklist for DSM-5', 'timeFrame': 'Baseline', 'description': 'The PCL-5 is a self-report measure assessing the severity of 20 PTSD symptoms. Scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.'}], 'primaryOutcomes': [{'measure': 'MMPI-2-RF-EX Suicidal/Death Ideation scale', 'timeFrame': 'Baseline', 'description': 'The MMPI-2-RF-EX Suicidal/Death Ideation scale is a self-report measure of current suicide risk contained within the instrument. T scores range from 45 to 100, with higher scores indicative of greater suicide risk.'}, {'measure': 'Beck Scale for Suicide Ideation (BSS)', 'timeFrame': 'Baseline', 'description': 'The BSS is a 21-item measure of past-week suicide ideation and desire for death. Responses to items are scored on a 3-point Likert scale (range of 0- 2). Scores range from 0 to 42, with higher scores indicating greater suicide risk.'}], 'secondaryOutcomes': [{'measure': 'Suicide Cognitions Scale (SCS)', 'timeFrame': 'Baseline', 'description': 'The SCS is an 18-item survey measuring suicide-related thoughts and beliefs, unclouding hopelessness, perceived burdensomeness, entrapment, and unbearability. Respondents rate their agreement with each statement on a 5-point Likert scale. Scores range from 18-90, with higher scores indicating more severe suicide risk.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicidal Ideation', 'Suicidal']}, 'referencesModule': {'references': [{'pmid': '40135882', 'type': 'DERIVED', 'citation': 'Khazem LR, Keen MA, Rodriguez TR, Ingram PB, Hay JM, Long CM, Bryan CJ, Anestis JC. Detecting Simulated Underreporting on the Minnesota Multiphasic Personality Inventory-3 (MMPI-3) in Veterans With Past-Month Death/Suicide Ideation. Suicide Life Threat Behav. 2025 Apr;55(2):e13170. doi: 10.1111/sltb.13170.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current project are is examine the incremental predictive utility of the MMPI-2-RF-EX validity scales in detecting simulated underreporting of suicide risk on the MMPI-2-RF-EX and other self-report measures of suicide risk in 150 military Veterans experiencing past-month death or suicidal ideation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* US military veteran\n* death or suicidal ideation/suicide attempt within the past month\n\nExclusion Criteria:\n\n* non-Veteran status\n* acute intoxication or active psychosis precluding provision of informed consent\n* an inability to communicate and comprehend English\n* residence outside the United States\n* lack of past-month death/suicide ideation or attempt\n* younger than 18 years of age'}, 'identificationModule': {'nctId': 'NCT04896151', 'briefTitle': 'Assessing the Utility of MMPI-2-RF-EX in Detecting Simulated Underreporting of Current Suicide Risk in Military Veterans', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Assessing the Utility of MMPI-2-RF-EX in Detecting Simulated Underreporting of Current Suicide Risk in Military Veterans', 'orgStudyIdInfo': {'id': '2020B0414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard MMPI', 'description': 'Participants will be instructed to complete the MMPI-2-RF-EX and other measures under standard conditions (e.g., to not simulate underreporting of suicide risk).', 'interventionNames': ['Diagnostic Test: Minnesota Multiphasic Personality Inventory -2- Restructured Form - Experimental']}, {'type': 'EXPERIMENTAL', 'label': 'Simulation MMPI', 'description': 'Participants will be instructed to conceal current suicide risk when completing the MMPI-2-RF-EX and other measures.', 'interventionNames': ['Diagnostic Test: Minnesota Multiphasic Personality Inventory -2- Restructured Form - Experimental']}], 'interventions': [{'name': 'Minnesota Multiphasic Personality Inventory -2- Restructured Form - Experimental', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['MMPI-2-RF-EX'], 'description': 'The MMPI-2-RF-EX is a broadband, self-report measure of personality and psychopathology was developed for research purposes in order to develop the MMPI-3 (Ben-Porath \\& Tellegen, 2020), which is comprised of a subset of MMPI-2-RF-EX items.', 'armGroupLabels': ['Simulation MMPI', 'Standard MMPI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Lauren Khazem, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'Rutgers University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lauren Khazem', 'investigatorAffiliation': 'Ohio State University'}}}}