Back to resultsTreatment for Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systems Training for Emotional Predictability and Problem Solving (STEPPS)
Treatment As Usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
Inclusion Criteria: Borderline Personality Disorder
Sites / Locations
- Roy J. and Lucille A. Carver College of Medicine, University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
STEPPS
Treatment as Usual
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00055315
First Posted
February 25, 2003
Last Updated
March 15, 2017
Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00055315
Brief Title
Treatment for Borderline Personality Disorder
Official Title
A Cognitive Group Treatment for Borderline Outpatients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
383 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STEPPS
Arm Type
Active Comparator
Arm Description
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
Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Systems Training for Emotional Predictability and Problem Solving (STEPPS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual (TAU)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Borderline Personality Disorder
Facility Information:
Facility Name
Roy J. and Lucille A. Carver College of Medicine, University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.
Citations:
PubMed Identifier
12107867
Citation
Blum N, Pfohl B, John DS, Monahan P, Black DW. STEPPS: a cognitive-behavioral systems-based group treatment for outpatients with borderline personality disorder--a preliminary report. Compr Psychiatry. 2002 Jul-Aug;43(4):301-10. doi: 10.1053/comp.2002.33497.
Results Reference
background
Citation
Black, D.W., Blum, N., Pfohl, B., & St. John, D: The STEPPS Group Treatment Program for Outpatients with Borderline Personality Disorder. Journal of Contemporary Psychotherapy 34:193-210, 2004.
Results Reference
background
PubMed Identifier
32368793
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment for Borderline Personality Disorder
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