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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00183651
Other study ID # R01MH034486
Secondary ID R01MH034486
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated January 31, 2012
Start date April 2004
Est. completion date June 2010

Study information

Verified date January 2012
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date June 2010
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

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).
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.
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.

Locations

Country Name City State
United States University of Washington, Department of Psychology, Behavior Research and Therapy Clinics Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Suicidal thoughts or attempts Measured at Year 2 No
Secondary Coping skills Measured at Year 2 No
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