- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055315
Treatment for Borderline Personality Disorder
March 15, 2017 updated by: Donald Black, University of Iowa
A Cognitive Group Treatment for Borderline Outpatients
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.
Study Overview
Status
Completed
Conditions
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
Interventional
Enrollment (Actual)
383
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Roy J. and Lucille A. Carver College of Medicine, University of Iowa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Borderline Personality Disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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. |
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
February 25, 2003
First Submitted That Met QC Criteria
February 25, 2003
First Posted (Estimate)
February 26, 2003
Study Record Updates
Last Update Posted (Actual)
March 16, 2017
Last Update Submitted That Met QC Criteria
March 15, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200112066
- R01MH063746 (U.S. NIH Grant/Contract)
- DATR A2-AIR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to share individual participant data.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Borderline Personality Disorder
-
University Hospital, Basel, SwitzerlandLeading House for the Latin American Region (Seed Money Grant SMG 1730)WithdrawnBorderline Personality Disorder (BPD)
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
University of EdinburghRecruitingEmotionally Unstable Personality Disorder, Borderline TypeUnited Kingdom
-
Hospital Universitari Vall d'Hebron Research InstituteUnknownBorderline Personality Disorder.Spain
-
Silvia Elisa Hurtado SantiagoCompletedPersonality Disorder, BorderlineSpain
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
Universitat Jaume IHospital de la RiberaNot yet recruitingBorderline Personality Disorder (BPD)Spain
-
University of OldenburgProf. René Hurlemann; Jella Voelter, M.Sc.RecruitingBorderline Personality Disorder (BPD)Germany
-
NHS Greater Glasgow and ClydeUnknownBorderline Personality Disorder (BPD) | Antisocial Personality Disorder (ASPD)United Kingdom
-
Rutgers, The State University of New JerseyActive, not recruitingBorderline Personality Disorder in AdolescenceUnited States
Clinical Trials on Systems Training for Emotional Predictability and Problem Solving (STEPPS)
-
Universitat Jaume ICentre d'Estudis i Formació Especialtzada Generalitat de CatalunyaActive, not recruiting
-
VA Office of Research and DevelopmentCompleted
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI); Drexel UniversityCompleted
-
University of PittsburghNational Institute of Nursing Research (NINR); National Institute on Aging...Completed
-
VA Office of Research and DevelopmentRecruiting
-
Carnegie Mellon UniversityHeadspace Meditation LimitedCompletedInflammation | Psychological StressUnited States
-
University of RochesterDartmouth-Hitchcock Medical Center; Association for the Blind and Visually...Completed
-
University of Texas Southwestern Medical CenterTexas A&M University; University of Texas Rio Grande ValleyCompletedMild Cognitive Impairment (MCI) | Alzheimer Disease | Lewy Body Dementia (LBD) | Frontotemporal Degeneration (FTD) | Vascular Contributions to Cognitive Impairment and Dementia (VCID) | Mixed Etiology Dementias (MED)United States
-
University of Missouri-ColumbiaCompletedPalliative Care | Caregivers | Medical OncologyUnited States
-
Rush University Medical CenterRecruitingHypertension | Adherence, MedicationUnited States