NCT01719731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

October 26, 2012

Last Update Submit

September 23, 2015

Conditions

Borderline Personality Disorder

Keywords

BPD

Outcome Measures

Primary Outcomes (1)

  • Zanarini Rating Scale for Borderline Personality Disorder

    A dimensional self-report measure of the nine DSM-IV symptoms of BPD

    Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up

Secondary Outcomes (1)

  • Borderline Evaluation of Severity over Time

    Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up

Other Outcomes (4)

  • Sheehan Disability Scale

    Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up

  • Weissman's Social Adjustment Scale

    Change from baseline through weeks 4,8,12, 6 month follow-up, 9 month follow-up, 12 month follow-up

  • Clinically Useful Depression Outcome Scale

    Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up

  • +1 more other outcomes

Study Arms (2)

Non-Education

PLACEBO COMPARATOR

This group will not receive the psychosocial education.

Behavioral: Non-Education

Education

ACTIVE COMPARATOR

This group will receive the psychosocial education

Behavioral: Education

Interventions

EducationBEHAVIORAL

This group will receive the psychoeducation

Education
Non-EducationBEHAVIORAL

This group will not receive the psychoeducation

Non-Education

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Males
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar I
  • Serious Substance Use Disorder
  • Subjects cannot be in treatment at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (2)

  • 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.

    PMID: 32368793DERIVED

  • 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.

    PMID: 28703950DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Mary C Zanarini, Ed.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

October 26, 2012

First Posted

November 1, 2012

Study Start

July 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

US(1)