Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-04-17 @ 1:13 PM
Study NCT ID:
NCT02326012
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2014-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-03', 'studyFirstSubmitDate': '2014-12-22', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Euroqol-5D (EQ-5D)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has Change from baseline in quality of life after 12 weeks and at 6 months after treatment has ended. Used for health economic evaluations.'}, {'measure': 'Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has Change from baseline in quality of life after 12 weeks and at 6 months after treatment has ended. Used for health economic evaluations.'}, {'measure': 'Patient Health Questionnaire (PHQ9)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'General Anxiety Disorder (GAD7)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change in patient parent health from baseline after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'The treatment credibility scale', 'timeFrame': 'One week after treatment start', 'description': 'Perceived treatment credibility'}, {'measure': 'Working Alliance Inventory (WAI) short version', 'timeFrame': 'Three weeks after treatment start', 'description': 'Perceived working alliance'}], 'primaryOutcomes': [{'measure': 'Deliberate Self-Harm Inventory - 9 item version', 'timeFrame': 'Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in self-harming behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.'}], 'secondaryOutcomes': [{'measure': 'Borderline Symptom List Behavior supplement (BSL-supplement)', 'timeFrame': 'Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in self-destructive and risky behaviors when measures weekly, after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'Difficulties in Emotion Regulation Scale -16 item version (DERS-16)', 'timeFrame': 'Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'Diary questionnaire (DQ)', 'timeFrame': 'Baseline (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in difficulties in emotion regulation when measures weekly, after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'Difficulties in Emotion Regulation Scale (DERS)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in difficulties in emotion regulation after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'Strengths and Difficulties Questionnaire Child and Parent version (SDQ-C/P)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in strengths and difficulties after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'Borderline personality features in childhood (BPFS-C)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in borderline personality features after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'The alcohol use disorders identification test - C (AUDIT-C)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in alcohol use after 12 weeks and at 6 months after treatment has ended.'}, {'measure': 'Evaluation of the Drug Use Disorders Identification Test - C (DUDIT-C)', 'timeFrame': 'Baseline (7 days prior to treatment start), post-treatment (12 weeks) and six months follow-up', 'description': 'Change from baseline in drug use after 12 weeks and at 6 months after treatment has ended.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nonsuicidal Self-Injury']}, 'referencesModule': {'references': [{'pmid': '29282024', 'type': 'DERIVED', 'citation': 'Bjureberg J, Sahlin H, Hellner C, Hedman-Lagerlof E, Gratz KL, Bjarehed J, Jokinen J, Tull MT, Ljotsson B. Emotion regulation individual therapy for adolescents with nonsuicidal self-injury disorder: a feasibility study. BMC Psychiatry. 2017 Dec 28;17(1):411. doi: 10.1186/s12888-017-1527-4.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy for Adolescents (ERITA) who self-harm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a primary diagnosis of NSSI as defined by DSM-5 Section 3\n* \\< 1 NSSI episode during the past month\n* at least one parent needs to commit to participate in the parent program\n\nExclusion Criteria:\n\n* bipolar disorder I or primary psychosis\n* severe suicidal ideation\n* ongoing substance dependence\n* Insertion/withdrawal of psychopharmacological substances within two months prior to the treatment\n* other acute primary axis I diagnosis (e.g. anorexia nervosa) that demand treatment in first hand\n* current life circumstances that would hinder the treatment (i.e. ongoing domestic abuse)\n* insufficient Swedish language skills\n* Cocurrent treatment with Mentalization based therapy (MBT) or Dialectical behavioral therapy (DBT)'}, 'identificationModule': {'nctId': 'NCT02326012', 'briefTitle': 'Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study', 'orgStudyIdInfo': {'id': '2014/1-31/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotion Regulation Individual Therapy for Adolescents', 'interventionNames': ['Behavioral: Emotion Regulation Individual Therapy for Adolescents']}], 'interventions': [{'name': 'Emotion Regulation Individual Therapy for Adolescents', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Emotion Regulation Individual Therapy for Adolescents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113 64', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Clara Hellner Gumpert', 'investigatorAffiliation': 'Karolinska Institutet'}}}}