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Psychoeducation of Borderline Patients

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Non-Education
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring BPD

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Non-Education

Education

Arm Description

This group will not receive the psychosocial education.

This group will receive the psychosocial education

Outcomes

Primary Outcome Measures

Zanarini Rating Scale for Borderline Personality Disorder
A dimensional self-report measure of the nine DSM-IV symptoms of BPD

Secondary Outcome Measures

Borderline Evaluation of Severity over Time
A self-report that measures change in severity of borderline psychopathology

Full Information

First Posted
October 26, 2012
Last Updated
September 23, 2015
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01719731
Brief Title
Psychoeducation of Borderline Patients
Official Title
Psychoeducation of Borderline Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
BPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Education
Arm Type
Placebo Comparator
Arm Description
This group will not receive the psychosocial education.
Arm Title
Education
Arm Type
Active Comparator
Arm Description
This group will receive the psychosocial education
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
This group will receive the psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
Non-Education
Intervention Description
This group will not receive the psychoeducation
Primary Outcome Measure Information:
Title
Zanarini Rating Scale for Borderline Personality Disorder
Description
A dimensional self-report measure of the nine DSM-IV symptoms of BPD
Time Frame
Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
Secondary Outcome Measure Information:
Title
Borderline Evaluation of Severity over Time
Description
A self-report that measures change in severity of borderline psychopathology
Time Frame
Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
Other Pre-specified Outcome Measures:
Title
Sheehan Disability Scale
Description
A self-report measure used to assess psychosocial impairment
Time Frame
Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
Title
Weissman's Social Adjustment Scale
Description
A self-report measure used to assess psychosocial impairment
Time Frame
Change from baseline through weeks 4,8,12, 6 month follow-up, 9 month follow-up, 12 month follow-up
Title
Clinically Useful Depression Outcome Scale
Description
A self-report designed to assess sensitivity to change in depression symptoms
Time Frame
Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
Title
Clinically Useful Anxiety Outcome Scale
Description
A self-report designed to assess sensitivity to change in anxiety symptoms
Time Frame
Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary C Zanarini, Ed.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Citations:
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
PubMed Identifier
28703950
Citation
Zanarini MC, Conkey LC, Temes CM, Fitzmaurice GM. Randomized Controlled Trial of Web-Based Psychoeducation for Women With Borderline Personality Disorder. J Clin Psychiatry. 2018 May/Jun;79(3):16m11153. doi: 10.4088/JCP.16m11153.
Results Reference
derived

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Psychoeducation of Borderline Patients

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