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Psychoeducation of Borderline Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mclean Hospital
Sponsor:
Information provided by (Responsible Party):
Mary Zanarini, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01719731
First received: October 26, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

Recent research suggests that BPD is a common, serious but treatable disorder with a better than previously recognized prognosis. Despite these findings, many patients with BPD are not given the borderline diagnosis by the mental health professionals treating them. It is also true that many newly diagnosed borderline patients are not provided with up-to-date information on the disorder even though psychoeducation has been found to be a useful form of treatment for other serious psychiatric illnesses.

The investigators have conducted a preliminary randomized trial of psychoeducation for BPD that found that those provided with immediate psychoeducation had a significantly greater reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than those with delayed psychoeducation.

However, both instruction and assessment of change over time were conducted in person by paraprofessionals. The importance of the current study is that it will allow the investigators to develop and test the efficacy of an internet-based program of psychoeducation for BPD that will be both cost efficient and easy to disseminate widely, particularly to underserved populations.


Condition Intervention
Borderline Personality Disorder
Behavioral: Education
Behavioral: Non-Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychoeducation of Borderline Patients

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    A dimensional self-report measure of the nine DSM-IV symptoms of BPD


Secondary Outcome Measures:
  • Borderline Evaluation of Severity over Time [ Time Frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    A self-report that measures change in severity of borderline psychopathology


Other Outcome Measures:
  • Sheehan Disability Scale [ Time Frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    A self-report measure used to assess psychosocial impairment

  • Weissman's Social Adjustment Scale [ Time Frame: Change from baseline through weeks 4,8,12, 6 month follow-up, 9 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    A self-report measure used to assess psychosocial impairment

  • Clinically Useful Depression Outcome Scale [ Time Frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    A self-report designed to assess sensitivity to change in depression symptoms

  • Clinically Useful Anxiety Outcome Scale [ Time Frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    A self-report designed to assess sensitivity to change in anxiety symptoms


Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Non-Education
This group will not receive the psychosocial education.
Behavioral: Non-Education
This group will not receive the psychoeducation
Active Comparator: Education
This group will receive the psychosocial education
Behavioral: Education
This group will receive the psychoeducation

  Hide Detailed Description

Detailed Description:

Clinical experience suggests that many people with borderline personality disorder (BPD) are not told of their borderline diagnosis by those treating them. Clinical experience also suggests that many people with newly diagnosed BPD are not provided with up-to-date information on the disorder. These practices are unfortunate as the results of a preliminary, randomized, controlled trial of psychoeducation for BPD conducted by the investigators suggest that informing patients about BPD soon after diagnostic disclosure may be an effective form of early treatment for BPD as it significantly reduced the severity of two of the core symptoms of borderline psychopathology—general impulsivity and unstable relationships.

This application proposes building on the PI's prior work in this area by developing a web-based program for the education of those with BPD and the assessment of three key outcomes; psychoeducation and assessment of outcome that had previously been provided by a team of clinically experienced research assistants. Both of these initiatives would allow for the widespread, cost-efficient dissemination of this early form of treatment for BPD—a form of treatment that has proven effective for other serious psychiatric illnesses.

The investigators first aim is to update our curriculum for teaching individuals with BPD the latest information concerning the disorder. This information will be organized into seven modules: introductory information (history of diagnosis, stigma associated with disorder, and demographic characteristics associated with BPD), symptoms of BPD, co-occurring disorders, etiology, longitudinal course, psychosocial treatments, and psychotropic medications. Some modules will be divided into sub-modules. For example, etiology will encompass childhood adversity, family history of psychiatric disorder, temperament, genetics, and other biological findings.

The investigators second aim is to develop a website for teaching the most up-to-date information about BPD and assessing three key outcomes: the severity of borderline psychopathology, psychosocial impairment, and treatment utilization over time. These outcomes will be assessed using self-report measures with proven psychometric properties. Symptom severity will be accomplished through the internet-based administration of the self-report version of the already widely used Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)—a dimensional measure of the nine Diagnostic and Statistical Manual of Mental Disorders, fourth edition(DSM-IV) symptoms of BPD. The investigators will also use the Borderline Evaluation of Severity over Time (BEST) developed by Pfohl and Blum as a secondary measure of change in severity of borderline psychopathology. Two other self-report measures will be used to assess psychosocial impairment (Sheehan Disability Scale and Weissman's Social Adjustment Scale). The use of nine forms of psychiatric treatment will be assessed using a self-report version of the treatment section of the Background Information Schedule and its follow-up analog.

The investigators third aim is to conduct a small-scale randomized controlled trial of psychoeducation for BPD using this set of web-based instructional and assessment tools. Half of the 80 subjects will be randomized to the investigators web-based intervention, which will occur a week after diagnostic disclosure, and half will not. The investigators plan to assess symptom severity, psychosocial impairment, and treatment utilization each week for 12 weeks (as the investigators did in our prior study) using the web-based self-report measures described above to determine its immediate effects. The investigators also plan to assess these outcomes using these measures at six months, nine months, and 12 months after randomization to determine if these effects are long lasting. The investigators hypothesize that two of the nine symptoms of DSM-IV BPD will decline significantly more in the subjects who receive psychoeducation than those who do not-general impulsivity and unstable relationships. The investigators further hypothesize that those in the treatment group will have more improved functioning in the social and vocational (but not family realm) than those in the non-treatment group. Finally, the investigators hypothesize that those receiving psychoeducation will be more likely to seek out ongoing psychiatric treatment and less likely to use emergency psychiatric services, such as hospitalizations, than those who do not receive psychoeducation concerning BPD.

If successful, the results of this trial would provide further evidence that psychoeducation is a useful form of early treatment for BPD. These results would also suggest that our web-based platform is an effective and cost efficient method for delivering such a program. Finally, these results would pave the way for a large-scale, multi-site randomized controlled trial of this web-based program in community settings.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Ages 18 to 30
  • Meets criteria for Borderline Personality Disorder
  • Intelligence Quotient must be 71 or higher

Exclusion Criteria:

  • Males
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar I
  • Serious Substance Use Disorder
  • Subjects cannot be in treatment at baseline
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719731

Contacts
Contact: Michelle Wedig, PhD. 617-855-3362 mwedig@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Michelle Wedig, PhD.    617-855-3362    mwedig@mclean.harvard.edu   
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Mary C Zanarini, Ed.D. Mclean Hospital
  More Information

No publications provided

Responsible Party: Mary Zanarini, Professor of Psychology, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01719731     History of Changes
Other Study ID Numbers: 1R34MH095818
Study First Received: October 26, 2012
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
BPD

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

ClinicalTrials.gov processed this record on November 25, 2014