We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment for Borderline Personality Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00055315
First Posted: February 26, 2003
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Donald Black, University of Iowa
  Purpose
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.

Condition Intervention
Borderline Personality Disorder Behavioral: Systems Training for Emotional Predictability and Problem Solving (STEPPS) Behavioral: Treatment As Usual (TAU)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cognitive Group Treatment for Borderline Outpatients

Resource links provided by NLM:


Further study details as provided by Donald Black, University of Iowa:

Enrollment: 383
Study Start Date: July 2002
Study Completion Date: April 2011
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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.

Behavioral: Treatment As Usual (TAU)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Borderline Personality Disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055315


Locations
United States, Iowa
Roy J. and Lucille A. Carver College of Medicine, University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Institute of Mental Health (NIMH)
  More Information

Publications:
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.

Responsible Party: Donald Black, Professor of and MD in Psychiatry, University of Iowa
ClinicalTrials.gov Identifier: NCT00055315     History of Changes
Other Study ID Numbers: 200112066
R01MH063746 ( U.S. NIH Grant/Contract )
DATR A2-AIR
First Submitted: February 25, 2003
First Posted: February 26, 2003
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders