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Seattle, Washington 98195


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.


Study summary:

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.


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


Study is Available At:


Original ID:

R01 MH34486


NCT ID:

NCT00183651


Secondary ID:

R01MH034486


Study Acronym:


Brief Title:

Treatment of Suicidal Women With Borderline Personality Disorder


Official Title:

Assessment and Treatment of Parasuicidal Patients


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Washington


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

99


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:April 2004
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:September 2008
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 31, 2012
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Coping skills
Time Frame:Measured at Year 2
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Suicidal thoughts or attempts
Time Frame:Measured at Year 2
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Standard dialectical behavior therapy (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).
Arm Name:S-DBT
Other Name:DBT, SDBT
Intervention Type:Behavioral
Name:Individual DBT with no DBT group sessions (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.
Arm Name:DBT-I
Other Name:DBT, DBT-I
Intervention Type:Behavioral
Name:Group Skills DBT with no DBT individual sessions
Description:DBT group skills training is 2.5 hours per week and includes individual case management.
Arm Name:DBT-S
Other Name:DBT, DBT-S

Study Arms

Study Arm Type:Active Comparator
Arm Name:DBT-S
Description:Participants receive dialectical behavior therapy group skills plus case management
Study Arm Type:Active Comparator
Arm Name:DBT-I
Description:Participants receive individual dialectical behavior therapy plus activities group
Study Arm Type:Experimental
Arm Name:S-DBT
Description:Participants receive standard dialectical behavior therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Washington
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:1845222
Reference Type:Reference
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.
PMID:7977884
Reference Type:Reference
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.
PMID:12062776
Reference Type:Reference
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. Review.
PMID:11525079
Reference Type:Reference
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.
PMID:10598211
Reference Type:Reference
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.
PMID:12562741
Reference Type:Reference
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.
PMID:10957822
Reference Type:Reference
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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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