Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-04-09 @ 11:55 PM
Study NCT ID:
NCT00183651
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Suicidal Women With Borderline Personality Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suicidal thoughts or attempts', 'timeFrame': 'Measured at Year 2'}], 'secondaryOutcomes': [{'measure': 'Coping skills', 'timeFrame': 'Measured at Year 2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Suicide', 'Women', 'Emotions', 'Psychotherapy, Group'], 'conditions': ['Borderline Personality Disorder', 'Suicide']}, 'referencesModule': {'references': [{'pmid': '1845222', 'type': 'BACKGROUND', 'citation': 'Linehan MM, Armstrong HE, Suarez A, Allmon D, Heard HL. Cognitive-behavioral treatment of chronically parasuicidal borderline patients. Arch Gen Psychiatry. 1991 Dec;48(12):1060-4. doi: 10.1001/archpsyc.1991.01810360024003.'}, {'pmid': '7977884', 'type': 'BACKGROUND', 'citation': 'Linehan MM, Tutek DA, Heard HL, Armstrong HE. Interpersonal outcome of cognitive behavioral treatment for chronically suicidal borderline patients. Am J Psychiatry. 1994 Dec;151(12):1771-6. doi: 10.1176/ajp.151.12.1771.'}, {'pmid': '12062776', 'type': 'BACKGROUND', 'citation': 'Linehan MM, Dimeff LA, Reynolds SK, Comtois KA, Welch SS, Heagerty P, Kivlahan DR. Dialectical behavior therapy versus comprehensive validation therapy plus 12-step for the treatment of opioid dependent women meeting criteria for borderline personality disorder. Drug Alcohol Depend. 2002 Jun 1;67(1):13-26. doi: 10.1016/s0376-8716(02)00011-x.'}, {'pmid': '11525079', 'type': 'BACKGROUND', 'citation': 'Swenson CR, Sanderson C, Dulit RA, Linehan MM. The application of dialectical behavior therapy for patients with borderline personality disorder on inpatient units. Psychiatr Q. 2001 Winter;72(4):307-24. doi: 10.1023/a:1010337231127.'}, {'pmid': '10598211', 'type': 'BACKGROUND', 'citation': 'Linehan MM, Schmidt H 3rd, Dimeff LA, Craft JC, Kanter J, Comtois KA. Dialectical behavior therapy for patients with borderline personality disorder and drug-dependence. Am J Addict. 1999 Fall;8(4):279-92. doi: 10.1080/105504999305686.'}, {'pmid': '12562741', 'type': 'BACKGROUND', 'citation': 'Verheul R, Van Den Bosch LM, Koeter MW, De Ridder MA, Stijnen T, Van Den Brink W. Dialectical behaviour therapy for women with borderline personality disorder: 12-month, randomised clinical trial in The Netherlands. Br J Psychiatry. 2003 Feb;182:135-40. doi: 10.1192/bjp.182.2.135.'}, {'pmid': '10957822', 'type': 'BACKGROUND', 'citation': 'Bohus M, Haaf B, Stiglmayr C, Pohl U, Bohme R, Linehan M. Evaluation of inpatient dialectical-behavioral therapy for borderline personality disorder--a prospective study. Behav Res Ther. 2000 Sep;38(9):875-87. doi: 10.1016/s0005-7967(99)00103-5.'}, {'type': 'BACKGROUND', 'citation': 'Koons, Cedar R; Robins, Clive J; Tweed, J. Lindsey; Lynch, Thomas R; Gonzalez, Alicia M; Morse, Jennifer Q; Bishop, G. Kay; Butterfield, Marian I; Bastian, Lori A. Efficacy of dialectical behavior therapy in women veterans with borderline personality disorder. Behavior Therapy. Vol 32(2) Spr 2001, 371-390'}, {'pmid': '33884617', 'type': 'DERIVED', 'citation': 'Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.'}, {'pmid': '32368793', 'type': 'DERIVED', 'citation': 'Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.'}, {'pmid': '25806661', 'type': 'DERIVED', 'citation': 'Linehan MM, Korslund KE, Harned MS, Gallop RJ, Lungu A, Neacsiu AD, McDavid J, Comtois KA, Murray-Gregory AM. Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis. JAMA Psychiatry. 2015 May;72(5):475-82. doi: 10.1001/jamapsychiatry.2014.3039.'}], 'seeAlsoLinks': [{'url': 'http://depts.washington.edu/brtc/', 'label': 'Click here for more information about the Behavioral Research and Therapy Clinics at the University of Washington'}]}, 'descriptionModule': {'briefSummary': 'This study is a component analysis of dialectical behavior therapy (DBT) to determine the importance of DBT skills training and DBT individual therapy in treating suicidal women with borderline personality disorder.', 'detailedDescription': "People with borderline personality disorder have limited behavioral skills and react abnormally to emotional stimulation. Standard dialectical behavior therapy (SDBT) has been shown to be an effective treatment for borderline personality disorder. This treatment combines weekly group sessions, at which patients learn new ways of dealing with their emotions, with weekly individual sessions with a therapist to discuss their emotions. The study compares SDBT to both individual DBT with no skills training and DBT skills training with no individual therapy. The study will determine whether efficacy of standard DBT is reduced when either DBT skills training or individual DBT therapy is removed.\n\nParticipants are randomly assigned to receive 1 year of SDBT, DBT with group sessions but no individual sessions, and DBT with individual sessions with no group sessions. Participants are monitored for 1 year after completing their assigned therapy. Throughout the 1-year study and during the 1-year follow-up period, self-report scales and questionnaires are used to assess participants every 4 months. These scales and questionnaires measure participants' suicidal thoughts and attempts, treatment compliance, emotional coping skills, social functioning, and overall well-being."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of BPD\n* At least one suicide attempt in the year prior to study entry AND at least one intentional self-injury within the 8 weeks prior to study entry\n* Willing and able to comply with all study requirements\n\nExclusion Criteria:\n\n* IQ less than 70\n* Life-threatening anorexia\n* Street homelessness with no contact information\n* Admittance to a hospital with no expectation of discharge within 3 weeks prior to study entry OR sentenced to a jail or prison term that will last for more than 3 weeks\n* Ordered by the court to receive psychological treatment\n* Meet DSM-IV criteria for schizophrenia, bipolar disorder, or seizure disorder\n* Medical conditions other than BPD that may interfere with the study'}, 'identificationModule': {'nctId': 'NCT00183651', 'briefTitle': 'Treatment of Suicidal Women With Borderline Personality Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Assessment and Treatment of Parasuicidal Patients', 'orgStudyIdInfo': {'id': 'R01MH034486', 'link': 'https://reporter.nih.gov/quickSearch/R01MH034486', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH034486', 'link': 'https://reporter.nih.gov/quickSearch/R01MH034486', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-DBT', 'description': 'Participants receive standard dialectical behavior therapy', 'interventionNames': ['Behavioral: Standard dialectical behavior therapy (SDBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DBT-I', 'description': 'Participants receive individual dialectical behavior therapy plus activities group', 'interventionNames': ['Behavioral: Individual DBT with no DBT group sessions (DBT-I)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DBT-S', 'description': 'Participants receive dialectical behavior therapy group skills plus case management', 'interventionNames': ['Behavioral: Group Skills DBT with no DBT individual sessions (DBT-S)']}], 'interventions': [{'name': 'Standard dialectical behavior therapy (SDBT)', 'type': 'BEHAVIORAL', 'otherNames': ['DBT, SDBT'], 'description': 'Standard DBT includes: 1) individual DBT therapy (1 hour per week), 2) DBT group skills training (2.5 hours per week), 3) telephone consultation (as needed), and 4) therapist consultation team (1 hour per week).', 'armGroupLabels': ['S-DBT']}, {'name': 'Individual DBT with no DBT group sessions (DBT-I)', 'type': 'BEHAVIORAL', 'otherNames': ['DBT, DBT-I'], 'description': 'Individual DBT (DBT-I) is 1 hour per week of individual therapy and 2.5 hours per week with the psychosocial activities group.', 'armGroupLabels': ['DBT-I']}, {'name': 'Group Skills DBT with no DBT individual sessions (DBT-S)', 'type': 'BEHAVIORAL', 'otherNames': ['DBT, DBT-S'], 'description': 'DBT group skills training is 2.5 hours per week and includes individual case management.', 'armGroupLabels': ['DBT-S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195-1525', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington, Department of Psychology, Behavior Research and Therapy Clinics', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Marsha M. Linehan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychology, University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marsha Linehan', 'investigatorAffiliation': 'University of Washington'}}}}