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Treatment for Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT00055315
Recruitment Status : Completed
First Posted : February 26, 2003
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Donald Black, University of Iowa

Tracking Information
First Submitted Date  ICMJE February 25, 2003
First Posted Date  ICMJE February 26, 2003
Last Update Posted Date March 16, 2017
Study Start Date  ICMJE July 2002
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00055315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment for Borderline Personality Disorder
Official Title  ICMJE A Cognitive Group Treatment for Borderline Outpatients
Brief Summary This study will expose patients to either a Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy for treating borderline personality disorder.
Detailed Description Participants are randomly assigned to receive either Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) for 20 weeks. STEPPS is a new cognitive behavioral treatment which involves skills training for emotion management and lifestyle behaviors as well as education for the affected individual's family members, friends, and professional caregivers. Participants are assessed at baseline and Weeks 4, 8, 12, 16, and 20. Interviews of patient's health care providers and family members and self-rating scales are used to assess patients. Follow-up assessments are made 1, 3, 6, 9, and 12 months after study completion. Participants must live within a reasonable driving distance of Iowa City, IA.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Borderline Personality Disorder
Intervention  ICMJE
  • Behavioral: Systems Training for Emotional Predictability and Problem Solving (STEPPS)
    STEPPS is a 20-week, manual-based, psychoeducational group treatment that combines skills training with cognitive-behavioral techniques. It includes a systems component to train family members, friends, and significant others.
  • Behavioral: Treatment As Usual (TAU)
Study Arms  ICMJE
  • Active Comparator: STEPPS
    Patients with Borderline Personality Disorder. Each subject met DSM-IV criteria for BPD, confirmed through a clinical interview and a review of the patient's case notes
    Intervention: Behavioral: Systems Training for Emotional Predictability and Problem Solving (STEPPS)
  • Placebo Comparator: Treatment as Usual

    Patients with Borderline Personality Disorder. Each subject met DSM-IV criteria for BPD, confirmed through a clinical interview and a review of the patient's case notes.

    TAU for this BPD population includes medical management, group and individual therapy.

    Intervention: Behavioral: Treatment As Usual (TAU)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2017)
383
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
160
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Borderline Personality Disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00055315
Other Study ID Numbers  ICMJE 200112066
R01MH063746 ( U.S. NIH Grant/Contract )
DATR A2-AIR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.
Responsible Party Donald Black, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account University of Iowa
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP