Treatment of Suicidal Women With Borderline Personality Disorder

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00183651

First Posted: September 16, 2005

Last Update Posted: February 2, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Marsha Linehan, University of Washington

Purpose

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.

Condition	Intervention	Phase
Borderline Personality Disorder Suicide	Behavioral: Standard dialectical behavior therapy (SDBT) Behavioral: Individual DBT with no DBT group sessions (DBT-I) Behavioral: Group Skills DBT with no DBT individual sessions (DBT-S)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Assessment and Treatment of Parasuicidal Patients

Resource links provided by NLM:

MedlinePlus related topics: Personality Disorders Suicide

U.S. FDA Resources

Further study details as provided by Marsha Linehan, University of Washington:

Primary Outcome Measures:

Suicidal thoughts or attempts [ Time Frame: Measured at Year 2 ]

Secondary Outcome Measures:

Coping skills [ Time Frame: Measured at Year 2 ]


Enrollment:	99
Study Start Date:	April 2004
Study Completion Date:	June 2010
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: S-DBT Participants receive standard dialectical behavior therapy	Behavioral: Standard dialectical behavior therapy (SDBT) 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). Other Name: DBT, SDBT
Active Comparator: DBT-I Participants receive individual dialectical behavior therapy plus activities group	Behavioral: Individual DBT with no DBT group sessions (DBT-I) Individual DBT (DBT-I) is 1 hour per week of individual therapy and 2.5 hours per week with the psychosocial activities group. Other Name: DBT, DBT-I
Active Comparator: DBT-S Participants receive dialectical behavior therapy group skills plus case management	Behavioral: Group Skills DBT with no DBT individual sessions (DBT-S) DBT group skills training is 2.5 hours per week and includes individual case management. Other Name: DBT, DBT-S

Detailed Description:

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.

Participants 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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of BPD
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
Willing and able to comply with all study requirements

Exclusion Criteria:

IQ less than 70
Life-threatening anorexia
Street homelessness with no contact information
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
Ordered by the court to receive psychological treatment
Meet DSM-IV criteria for schizophrenia, bipolar disorder, or seizure disorder
Medical conditions other than BPD that may interfere with the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183651

Locations


United States, Washington
University of Washington, Department of Psychology, Behavior Research and Therapy Clinics
Seattle, Washington, United States, 98195-1525

Sponsors and Collaborators

University of Washington

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Marsha M. Linehan, PhD	Department of Psychology, University of Washington

More Information

Additional Information:

Click here for more information about the Behavioral Research and Therapy Clinics at the University of Washington This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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. Review.

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.

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.

Bohus M, Haaf B, Stiglmayr C, Pohl U, Böhme 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.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: JAMA Psychiatry. 2015 Sep;72(9):951.


Responsible Party:	Marsha Linehan, Professor, University of Washington
ClinicalTrials.gov Identifier:	NCT00183651 History of Changes
Other Study ID Numbers:	R01MH034486 ( U.S. NIH Grant/Contract )
First Submitted:	September 13, 2005
First Posted:	September 16, 2005
Last Update Posted:	February 2, 2012
Last Verified:	January 2012

Keywords provided by Marsha Linehan, University of Washington:


Suicide Women Emotions Psychotherapy, Group

Additional relevant MeSH terms:


Suicide Personality Disorders Borderline Personality Disorder	Self-Injurious Behavior Behavioral Symptoms Mental Disorders

To Top