Borderline Personality DisorderNCT01719731
Psychoeducation of Borderline Patients
A study testing Education and Non-Education in people with Borderline Personality Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Education and Non-Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Ages 18 to 30
- Meets criteria for Borderline Personality Disorder
- Intelligence Quotient must be 71 or higher
Who cannot join
- Males
- Schizophrenia
- Schizoaffective Disorder
- Bipolar I
- Serious Substance Use Disorder
- Subjects cannot be in treatment at baseline
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Education, Non-Education
- Keywords
- BPD
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
This group will receive the psychoeducation
Non-EducationBehavioural
This group will not receive the psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Non-Education | Placebo comparator | This group will not receive the psychosocial education. Receives: Behavioral: Non-Education |
| Education | Active comparator | This group will receive the psychosocial education Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zanarini Rating Scale for Borderline Personality Disorder
A dimensional self-report measure of the nine DSM-IV symptoms of BPD
Measured: 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
A self-report that measures change in severity of borderline psychopathology
Measured: Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Zanarini, Mclean Hospital
- Investigators
- Mary C Zanarini, Ed.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719731
- Sponsor's protocol ID
- 1R34MH095818
- Status last verified
- Sep 2015
- First submitted
- 26 Oct 2012
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32368793Zanarini 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.
PubMed 28703950
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation of Borderline Patients
- ClinicalTrials.gov ID
- NCT01719731
- Acronym / sponsor ID
- 1R34MH095818
- Conditions
- Borderline Personality Disorder
- Keywords
- BPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Education | Placebo comparator | Behavioral: Non-EducationThis group will not receive the psychosocial education. |
| Education | Active comparator | Behavioral: EducationThis group will receive the psychosocial education |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Ages 18 to 30
- Meets criteria for Borderline Personality Disorder
- Intelligence Quotient must be 71 or higher
Key exclusion criteria (6 listed)
- Males
- Schizophrenia
- Schizoaffective Disorder
- Bipolar I
- Serious Substance Use Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationThis group will receive the psychoeducation | Behavioural | Education |
| Non-EducationThis group will not receive the psychoeducation | Behavioural | Non-Education |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Derived from this study: PubMed 32368793Storebo 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.
- Derived from this study: PubMed 28703950Zanarini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary C Zanarini, Ed.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Non-Education in people with Borderline Personality Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719731, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.