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AzTrials

Borderline Personality DisorderPhase 2NCT00183651

Treatment of Suicidal Women With Borderline Personality Disorder

A Phase 2 study testing Standard dialectical behavior therapy (SDBT), Individual DBT with no DBT group sessions (DBT-I) and Group Skills DBT with no DBT individual sessions (DBT-S) in people with Borderline Personality Disorder and Suicide, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Borderline Personality Disorder, Suicide
What is being tested?
Standard dialectical behavior therapy (SDBT), Individual DBT with no DBT group sessions (DBT-I) and Group Skills DBT with no DBT individual sessions (DBT-S)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteUnited States
Study dates
Apr 2004to Jun 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Seattle, Washington, 98195-1525

Other trials in United States

About this study

Official title: Assessment and Treatment of Parasuicidal Patients

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.

Read the 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.

Being tested
Standard dialectical behavior therapy (SDBT), Individual DBT with no DBT group sessions (DBT-I), Group Skills DBT with no DBT individual sessions (DBT-S)
Keywords
Suicide, Women, Emotions, Psychotherapy, Group
Medical subject headings
Borderline Personality Disorder, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard dialectical behavior therapy (SDBT)Behavioural

    Also called DBT, 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)Behavioural

    Also called DBT, 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)Behavioural

    Also called DBT, DBT-S

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

Study groups in NCT00183651
Study groupRoleWhat they receive
S-DBTExperimentalParticipants receive standard dialectical behavior therapy
Receives: Behavioral: Standard dialectical behavior therapy (SDBT)
DBT-IActive comparatorParticipants receive individual dialectical behavior therapy plus activities group
Receives: Behavioral: Individual DBT with no DBT group sessions (DBT-I)
DBT-SActive comparatorParticipants receive dialectical behavior therapy group skills plus case management
Receives: Behavioral: Group Skills DBT with no DBT individual sessions (DBT-S)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suicidal thoughts or attempts

    Measured: Measured at Year 2

Secondary outcomes (1)

  1. Coping skills

    Measured: Measured at Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Primary completionSep 2008
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00183651
Sponsor's protocol ID
R01MH034486
Other IDs
R01MH034486
Status last verified
Jan 2012
First submitted
13 Sep 2005
Last updated
2 Feb 2012
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1001/archpsyc.1991.01810360024003.

    PubMed 1845222

  • 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.

    PubMed 7977884

  • 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.

    PubMed 12062776

  • 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.

    PubMed 11525079

  • 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.

    PubMed 10598211

  • 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.

    PubMed 12562741

  • 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.

    PubMed 10957822

  • 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

  • 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.

    PubMed 33884617

  • 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.

    PubMed 32368793

  • 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.

    PubMed 25806661

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Standard dialectical behavior therapy (SDBT), Individual DBT with no DBT group sessions (DBT-I) and Group Skills DBT with no DBT individual sessions (DBT-S) in people with Borderline Personality Disorder and Suicide, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicidal thoughts or attempts (time frame: Measured at Year 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00183651, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.

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