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Psychoeducation of Borderline Patients

This study is not yet open for participant recruitment.
Verified March 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: March 25, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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

  Show Detailed Description

  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
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 Not yet 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: March 25, 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 May 23, 2013