NCT00183651

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

4.4 years

First QC Date

September 13, 2005

Last Update Submit

January 31, 2012

Conditions

Keywords

SuicideWomenEmotionsPsychotherapy, Group

Outcome Measures

Primary Outcomes (1)

  • Suicidal thoughts or attempts

    Measured at Year 2

Secondary Outcomes (1)

  • Coping skills

    Measured at Year 2

Study Arms (3)

S-DBT

EXPERIMENTAL

Participants receive standard dialectical behavior therapy

Behavioral: Standard dialectical behavior therapy (SDBT)

DBT-I

ACTIVE COMPARATOR

Participants receive individual dialectical behavior therapy plus activities group

Behavioral: Individual DBT with no DBT group sessions (DBT-I)

DBT-S

ACTIVE COMPARATOR

Participants receive dialectical behavior therapy group skills plus case management

Behavioral: Group Skills DBT with no DBT individual sessions (DBT-S)

Interventions

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).

Also known as: DBT, SDBT
S-DBT

Individual DBT (DBT-I) is 1 hour per week of individual therapy and 2.5 hours per week with the psychosocial activities group.

Also known as: DBT, DBT-I
DBT-I

DBT group skills training is 2.5 hours per week and includes individual case management.

Also known as: DBT, DBT-S
DBT-S

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington, Department of Psychology, Behavior Research and Therapy Clinics

Seattle, Washington, 98195-1525, United States

Location

Related Publications (11)

  • 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: 1845222BACKGROUND
  • 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: 7977884BACKGROUND
  • 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: 12062776BACKGROUND
  • 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: 11525079BACKGROUND
  • 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: 10598211BACKGROUND
  • 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: 12562741BACKGROUND
  • 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.

    PMID: 10957822BACKGROUND
  • 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

    BACKGROUND
  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Borderline Personality DisorderSuicide

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Marsha M. Linehan, PhD

    Department of Psychology, University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2004

Primary Completion

September 1, 2008

Study Completion

June 1, 2010

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations