Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT01018433
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2009-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment for Non-Suicidal Self-Injury in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2009-11-20', 'studyFirstSubmitQcDate': '2009-11-20', 'lastUpdatePostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NSSI frequency and severity', 'timeFrame': 'Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up'}], 'secondaryOutcomes': [{'measure': 'BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA', 'timeFrame': 'Baseline, Post-Intervention, 3 month follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['self-injury', 'non-suicidal self-injury', 'deliberate self-harm', 'self-mutilation'], 'conditions': ['Non-suicidal Self-injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate an intervention specifically for non-suicidal self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled pilot study in order to determine the feasibility and acceptability of the intervention and to investigate change in NSSI frequency and severity over time.', 'detailedDescription': 'Non-suicidal self-injury (NSSI), deliberate harm to the body without suicidal intent, is highly prevalent in young adults, with 1 in 10 college students engaging in over 100 episodes in their lifetimes. Consequences of NSSI are severe, including physical injury ranging in medical severity, distress from shame associated with the behavior, social isolation, psychological symptoms, and increased risk and lethality of NSSI over time. Despite the prevalence and significant consequences of NSSI, no empirically supported treatments specific to NSSI exist. The purpose of this study is to develop, implement, and evaluate an intervention specifically for NSSI in young adults, the Treatment for Self-Injurious Behaviors (T-SIB). This time-limited intervention will integrate theoretically-based strategies whose utility has been identified through empirical research with the goal of reducing frequency and severity of NSSI. The research plan consists of 2 phases. During Phase 1, 12 patients will be treated in an open pilot trial. During Phase 2, 60 patients will be treated in a randomized controlled pilot study to determine the feasibility and acceptability of T-SIB, investigate change in NSSI frequency and severity between T-SIB and treatment as usual (TAU) through a 3-month follow up period, and evaluate the research design of the randomized controlled pilot study to inform both the utility and design of a larger randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-29\n* NSSI within the past month OR history of NSSI and urge to self-injure within the past month\n\nExclusion Criteria:\n\n* Psychotic symptoms\n* Severe suicidal ideation'}, 'identificationModule': {'nctId': 'NCT01018433', 'acronym': 'T-SIB', 'briefTitle': 'Treatment for Non-Suicidal Self-Injury in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Fordham University'}, 'officialTitle': 'Development of an Intervention for Non-Suicidal Self-Injury in Young Adults', 'orgStudyIdInfo': {'id': 'K23MH082824', 'link': 'https://reporter.nih.gov/quickSearch/K23MH082824', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23MH082824', 'link': 'https://reporter.nih.gov/quickSearch/K23MH082824', 'type': 'NIH'}, {'id': 'DATR AK-TNAI2', 'type': 'OTHER_GRANT', 'domain': 'National Institute of Mental Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T-SIB', 'description': 'Treatment for self-injurious behaviors; study intervention', 'interventionNames': ['Behavioral: T-SIB']}, {'type': 'OTHER', 'label': 'Treatment as Usual', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'T-SIB', 'type': 'BEHAVIORAL', 'description': 'Treatment for self-injurious behaviors; study psychotherapy', 'armGroupLabels': ['T-SIB']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'otherNames': ['TAU'], 'description': 'Can include other psychotherapy and pharmacotherapy', 'armGroupLabels': ['Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10458', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Fordham University', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Margaret S Andover, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fordham University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fordham University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}