Treatment of Suicidal Women With Borderline Personality Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183651

Purpose

This study will compare three different therapies to determine which is most effective 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 II

MedlinePlus related topics: Personality Disorders Suicide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Assessment and Treatment of Parasuicidal Patients

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Suicidal thoughts or attempts [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Coping skills [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2004
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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

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 will compare SDBT to both individual DBT with no skills training and DBT skills training with no individual therapy. This study will determine which of these therapies is most effective in treating suicidal women with borderline personality disorder.

Participants will be 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 will be 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 will be used to assess participants every 4 months. These scales and questionnaires will measure participants' suicidal thoughts and attempts, treatment compliance, emotional coping skills, social functioning, and overall well-being.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Marsha M. Linehan, PhD

Department of Psychology, University of Washington

More Information

Click here for more information about the Behavior 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, 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.

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

Responsible Party:	University of Washington ( Marsha M. Linehan, PhD, Professor of Psychology )
Study ID Numbers:	R01 MH34486, DATR A2-AIR
Study First Received:	September 13, 2005
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00183651
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Suicide
Women
Emotions
Psychotherapy, Group

Study placed in the following topic categories:

Mental Disorders
Suicide
Borderline Personality Disorder

Behavioral Symptoms
Self-Injurious Behavior
Personality Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009