Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-29 @ 2:01 PM
Study NCT ID:
NCT01986257
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2013-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERGT for Women Engaging in NSSI - an Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2013-11-11', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of non-suicidal self-injury as measured by Deliberate Self-Harm Inventory (DSHI)', 'timeFrame': 'Baseline (from inclusion to treatment start), (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in deliberate self-harm after 14 weeks and at 6- and 12 months after treatment has ended.'}], 'secondaryOutcomes': [{'measure': 'Borderline Symptom List Behavior supplement (BSL-supplement)', 'timeFrame': 'Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks), and six and twelve months follow-up.', 'description': 'Change from Baseline in self-destructive behaviors after 14 weeks and at 6- and 12 months after treatment has ended.'}, {'measure': 'Difficulties in Emotion Regulation Scale (DERS)', 'timeFrame': 'Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in difficulties with emotion regulation after 14 weeks and at 6- and 12 months after treatment has ended.'}, {'measure': 'Diary questionnaire (DQ)', 'timeFrame': 'Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in positive and negative affect after 14 weeks and at 6- and 12 months after treatment has ended.'}, {'measure': 'The Borderline Evaluation of Severity over Time (BEST).', 'timeFrame': 'Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in Borderline severity symptoms after 14 weeks and at 6- and 12 months after treatment has ended.'}, {'measure': 'The Depression Anxiety Stress Scales (DASS)', 'timeFrame': 'Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in depression and anxiety after 14 weeks and at 6- and 12 months after treatment has ended.'}, {'measure': 'Inventory of Interpersonal Problems - Borderline Personality Disorder (IIP-BPD)', 'timeFrame': 'Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in interpersonal problems after 14 weeks and at 6- and 12 months after treatment has ended.'}, {'measure': 'Sheehan Disability Scale (SDS)', 'timeFrame': 'Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in global functioning after 14 weeks and at 6- and 12 months after treatment has ended.'}, {'measure': 'Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)', 'timeFrame': 'Baseline, post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in societal costs after 14 weeks and at 6- and 12 months after treatment has ended.'}, {'measure': 'Euroqol-5D (EQ-5D)', 'timeFrame': 'Baseline, post-treatment (14 weeks) and six and twelve months follow-up.', 'description': 'Change from Baseline in quality of life after 14 weeks and at 6- and 12 months after treatment has ended.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Borderline Personality Disorder', 'Non-suicidal Self-injury (NSSI)']}, 'referencesModule': {'references': [{'pmid': '28982814', 'type': 'DERIVED', 'citation': 'Sahlin H, Bjureberg J, Gratz KL, Tull MT, Hedman E, Bjarehed J, Jokinen J, Lundh LG, Ljotsson B, Hellner C. Emotion regulation group therapy for deliberate self-harm: a multi-site evaluation in routine care using an uncontrolled open trial design. BMJ Open. 2017 Oct 5;7(10):e016220. doi: 10.1136/bmjopen-2017-016220.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim is to investigate the effectiveness of Emotion Regulation Group Therapy (ERGT) for women who self-harm in ordinary psychiatric outpatient health care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NSSI a minimum of three times in the last six months\n* Meets at least three criteria for Borderline Personality Disorder according to DSM-IV-TR\n* Contact with an other individual therapist, psychiatrist, "case manager" or equal\n\nExclusion Criteria:\n\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* Bipolar disorder I or primary psychosis\n* Current substance dependence (the last month)\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': 'NCT01986257', 'briefTitle': 'ERGT for Women Engaging in NSSI - an Effectiveness Study', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Emotion Regulation Group Therapy (ERGT) for Women Engaging in Non-suicidal Self-Injury (NSSI) - an Effectiveness Study', 'orgStudyIdInfo': {'id': 'DNR 2013/1321-31/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotion Regulation Group Therapy (ERGT).', 'interventionNames': ['Behavioral: Emotion Regulation Group Therapy (ERGT).']}], 'interventions': [{'name': 'Emotion Regulation Group Therapy (ERGT).', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Emotion Regulation Group Therapy (ERGT).']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113 64', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Clara Hellner Gumpert', 'investigatorAffiliation': 'Karolinska Institutet'}}}}