Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00401102
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2006-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079062', 'term': 'Interpersonal Psychotherapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cjacobson@iona.edu', 'phone': '646-207-3563', 'title': 'Dr. Colleen Jacobsonn', 'organization': 'Iona College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'All participants recieved Interpersonal psychotherapy', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CGI', 'timeFrame': '1 week', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'C-GAS', 'timeFrame': '1 month', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'CDRS', 'timeFrame': '1 week', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Self-Injurious Thoughts and Behaviors Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'All participants recieved Interpersonal psychotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'unitOfMeasure': 'episodes of self-injury past month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for all subjects who completed the study was examined - however because this was a small pilot study and only 5 subjects completed treatment, no statistical tests were completed.'}, {'type': 'PRIMARY', 'title': 'Self-injury Monitoring Card', 'timeFrame': '1 month', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory', 'timeFrame': '2 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Multidimensional Anxiety Scale for Children', 'timeFrame': 'recently', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'All participants recieved Interpersonal psychotherapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'All participants recieved Interpersonal psychotherapy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '1.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-20', 'studyFirstSubmitDate': '2006-11-15', 'resultsFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2006-11-15', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-20', 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CGI', 'timeFrame': '1 week'}, {'measure': 'C-GAS', 'timeFrame': '1 month'}, {'measure': 'CDRS', 'timeFrame': '1 week'}, {'measure': 'Self-Injurious Thoughts and Behaviors Interview', 'timeFrame': '8 weeks'}, {'measure': 'Self-injury Monitoring Card', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': '2 weeks'}, {'measure': 'Multidimensional Anxiety Scale for Children', 'timeFrame': 'recently'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['self-injurious behavior', 'depression', 'adolescents', 'psychotherapy'], 'conditions': ['Depression', 'Self-injurious Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the feasibility of using Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) to treat adolescents who are experiencing symptoms of depression and are engaging in non-suicidal self-injurious behaviors. The trial will include recruiting 10 particpants, administering 12-sessions of individual IPT-A, and determining how the IPT-A protocol needs to be amended to adequately address the self-injury in addition to depression.', 'detailedDescription': 'Engagement in non-suicidal self-injury (NSSI), purposefully harming oneself without the conscious intent to die such as cutting or burning, is pervasive among adolescents. Lifetime prevalence estimates among community samples of high school students range from 13.0% to 23.2%. Despite the significance of this public health problem, there are no known interventions that successfully reduce the frequency of NSSI or prevent NSSI in adolescents. The goal of the current study is to develop an effective psychosocial intervention for NSSI among adolescents who are engaging in self-injury and have a depressive disorder. Specifically, we will amend Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), a psychotherapy that has demonstrated efficacy in treating depressed adolescents (Mufson et al., 1994, 1999, 2004), for use with adolescents with depression who are engaging in NSSI, with the ultimate goal of curing the depression and NSSI. Ten participants will be administered IPT-A and assessed several times throughout the course of the trial. It is expected that IPT-A will be a useful treatment for co-morbid depression and self-injury, although adaptations to the protocol will likely be needed to address the behavioral aspect of the self-injury. Data analyses will be descriptive in nature and involve examining the individual trajectories of depression and NSSI over time. The data obtained from the current study will lay the groundwork for an ultimate randomized controlled trial in which we plan to compare IPT-A versus nondirective supportive therapy in the treatment of co-morbid depression and NSSI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 12 to 18 years of age\n2. Diagnosis of MDD, Dysthymic Disorder, Depressive Disorder NOS, Adjustment Disorder with depressed Mood\n3. Non-suicidal self-injurious behavior\n4. CDRS \\>= 36\n5. C-GAS \\<= 65\n6. English speaking patient\n7. One English speaking caregiver -\n\nExclusion Criteria:\n\n1. Suicide attempt within past 6 months or actively suicidal\n2. Severe incident of non-suicidal self-injury in past 3 months\n3. Severe episode of MDD\n4. Treatment resistant non-suicidal self-injury\n5. Frequent non-suicidal self-injury\n6. Mentally retarded\n7. Current diagnosis of: PTSD, OCD, Schizophrenia, Bipolar Disorder, Psychosis, Substance Dependence, ADHD\n8. Current substance use\n9. Currently in active treatment for same condition\n10. Currently taking antidepressant medication\n11. Medical illness likely to interfere with treatment -'}, 'identificationModule': {'nctId': 'NCT00401102', 'acronym': 'IPT-ASI', 'briefTitle': 'Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'An Open-clinical Trial of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) for Depressed Adolescents Engaged in Non-suicidal Self-injury', 'orgStudyIdInfo': {'id': '5332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interpersonal psychotherapy', 'description': 'All participants received interpersonal psychotherapy adapted for self-injury', 'interventionNames': ['Behavioral: Interpersonal Psychotherapy for Depressed Adolescents']}], 'interventions': [{'name': 'Interpersonal Psychotherapy for Depressed Adolescents', 'type': 'BEHAVIORAL', 'description': "Open clinical trial of IPT-ASI for depressed and self-injuring adolescents, 12-18 years. Goal is to assess feasibility of using IPT-A protocol for teens with co-morbid depression and self-injury. All eligible participants receive 12 weeks of individual IPT-ASI with optional monthly booster sessions. IPT-ASI is a psychosocial intervention that focuses on the importance of interpersonal relationships in relation to psychological functioning. The first phase (4 weeks) includes a review of depression and self-injury symptoms, psycho-education about depression and self-injury, and a detailed assessment of the patient's important interpersonal relationships. The middle phase (weeks 5-9) involves interpersonal skill building, including communication skills, affect identification and expression, problem solving. The final phase ( weeks 10-12) involves review of skills, generalization of skills to other relationships, termination.", 'armGroupLabels': ['Interpersonal psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Colleen Jacobson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYSPI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'MINT: Mental Health Initiative', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}