We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychoeducation of Borderline Patients

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.
ClinicalTrials.gov Identifier: NCT01719731
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Mary Zanarini, Mclean Hospital

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.


Condition or disease Intervention/treatment
Borderline Personality Disorder Behavioral: Education Behavioral: Non-Education

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychoeducation of Borderline Patients
Study Start Date : July 2013
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    A dimensional self-report measure of the nine DSM-IV symptoms of BPD


Secondary Outcome Measures :
  1. 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 ]
    A self-report that measures change in severity of borderline psychopathology


Other Outcome Measures:
  1. Sheehan Disability Scale [ Time Frame: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up ]
    A self-report measure used to assess psychosocial impairment

  2. 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 ]
    A self-report measure used to assess psychosocial impairment

  3. 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 ]
    A self-report designed to assess sensitivity to change in depression symptoms

  4. 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 ]
    A self-report designed to assess sensitivity to change in anxiety symptoms



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 to 30 Years   (Adult)
Sexes 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

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): NCT01719731


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Mary C Zanarini, Ed.D. Mclean Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Zanarini, Professor of Psychology, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01719731     History of Changes
Other Study ID Numbers: 1R34MH095818 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015

Keywords provided by Mary Zanarini, Mclean Hospital:
BPD

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