Borderline Personality DisorderNCT00467038
Treatment of Aggression, Anger and Emotional Dysregulation in Borderline Personality Disorder
A study testing Dialectical Behavior in people with Borderline Personality Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study examines the effects of 12 months of dialectical behavior therapy (DBT) for subjects with borderline personality disorder on aggression, anger and emotional dysregulation. Treatment effects will be measured by changes in interview, self-report, psychophysiology testing and fMRI neuroimaging. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Dialectical Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to provide written informed consent
- In good physical health as confirmed by a complete physical exam, electrocardiogram, neurological exam, and routine laboratory tests of blood and urine
- A negative urine toxicology screen
- Completion of psychiatric evaluations, medical evaluations, and self-report questionnaires through separate protocol- Biological Correlates of Personality Disorders (GCO #88-244)
- meet DSM-IV criteria for borderline personality disorder and have an overt aggression scale- modified aggression subscale score of six or above on one of two OASM pre-treatment screens.
- not currently be taking any psychiatric medications. If they have taken psychiatric medications in the past, they must be at least 2 weeks (6 half-lives) medication-free prior to participating in the study. These medications include mood stabilizers, antidepressants, antipsychotics, and benzodiazepines.
Who cannot join
- meet criteria for schizophrenia, bipolar I disorder, schizoaffective disorder or any other psychotic disorder.
- have met criteria for substance abuse or dependence during the 6 months prior to entry into the study
- have a past history of intravenous drug use, cocaine abuse or dependence, or any substance dependence that resulted in serious medical sequelae
- meet criteria for current MDE, as they may require antidepressant treatment
- have made a suicide attempt or had a psychiatric hospitalization during the 6 months prior to entry into the study
- be on any psychotropic medication(s) upon entry into the study
- be in concurrent psychotherapy (case management services and work therapy programs are not considered individual psychotherapy)
- be pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the effects of 12 months of dialectical behavior therapy (DBT) for subjects with borderline personality disorder on aggression, anger and emotional dysregulation. Treatment effects will be measured by changes in interview, self-report, psychophysiology testing and fMRI neuroimaging.
Read the detailed description
Borderline Personality Disorder (BPD) is a disabling disorder characterized by poor affect regulation and poor impulse control. This often results in impaired interpersonal relationships and maladaptive behavioral patterns, including anger dyscontrol, aggression towards others and self-destructive behaviors. Evidence suggests that is a relatively common disorder, affecting 2% of the population 1. In addition, BPD patients have more frequent psychiatric hospitalizations, greater use of outpatient psychotherapy and more visits to the emergency room than individuals with any other psychiatric disorder 3, 4. Due to the heterogeneity of symptoms that fall under the DSM-IV definition of BPD, the most productive efforts to understand the underlying neurobiology of this disorder have employed a dimensional approach. This application focuses on the domain of affective instability and altered emotion regulation, believed by many to be at the core of the disorder 5.
The emotional dysregulation of BPD appears to be a biological vulnerability. This vulnerability includes both increased emotional reactivity, as well as an impaired capacity to employ effortful control in the modulation of emotional reactions. The emotional reactivity is manifested by high sensitivity to emotional stimuli and heightened emotional intensity5 and may reflect limbic system over activity. The impairment in emotional modulation results in a slow return to the baseline emotional state and may reflect deficits in prefrontal regulatory regions. While data supporting this formulation are limited, self-report measures of responses to various emotional stimuli and more recently, objective, non-verbal physiological measures including startle eye blink modulation (SEM), have been used to test this theory.
SEM is a well-established technique used to study the psychophysiology of emotion and has been shown to reflect amygdala activation6. Our research group has demonstrated exaggerated affective startle in BPD patients compared to healthy control subjects at later probe positions in response to words with emotionally negative valence, selected specifically to target emotions commonly unpleasant for BPD patients. Emerging neurobiological theories based on preliminary functional neuroimaging studies posit that BPD is a hyperarousal-dyscontrol syndrome 4, implicating dysfunction in amygdala activity coupled with weakening of prefrontal inhibitory control. Several neuroimaging studies from our research group have helped advance this idea7. Building on these exciting findings and the expertise available, this project uses a translational approach to study treatment effects on emotional regulation in BPD with SEM and prediction of treatment response with functional magnetic resonance imaging (fMRI).
Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD8, 9. It has gained considerable popularity and is included as a component of the APA guidelines for treatment of BPD10. While this approach stresses skills and techniques for emotional regulation, and encourages cognitive control over maladaptive behavioral patterns, there have been neither neuroimaging nor psychophysiological studies of the effect of DBT on emotional processing in BPD, despite its proven efficacy. While neuroimaging and psychophysiological studies of a psychotherapeutic treatment have been done in major depression 11, 12 13, no such studies have been done in BPD. By examining changes in affective startle and baseline predictors of response with fMRI blood oxygenation level dependent (BOLD) activation patterns associated with DBT treatment, this project aims to better characterize the nature of emotional dysregulation in BPD, and identify features that predict a good response to DBT treatment. In addition, the project will explore the relationship between clinical improvement of BPD symptomatology with DBT treatment and changes in neurobiological measures by performing follow-up SEM after six and twelve months of DBT treatment. This approach will help elucidate the neuroanatomy of abnormal emotional processing in BPD and may help identify potential strategies for correcting these deficits.
- Conditions
- Borderline Personality Disorder
- Being tested
- Dialectical Behavior
- Keywords
- affect, aggression, anger, behavior therapy, borderline personality disorder, MRI, functional
- Medical subject headings
- Borderline Personality Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical BehaviorBehavioural
Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behavior Therapy | Other | Dialectical Behavior Therapy Receives: Behavioral: Dialectical Behavior |
| Healthy Controls | No intervention | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Report of Difficulties in Emotion Regulation (DERS)
The present study examines DBT treatment effect on emotion regulation in unmedicated outpatients with BPD as measured by changes in the Difficulties in Emotion Regulation Scale. The DERS is a brief, 36-item, self-report questionnaire.
DERS total score ranges from 36- 180. Higher scores reflect higher difficulties in emotion regulation.
The measure yields a total score as well as scores on six scales derived through factor analysis:
- Nonacceptance of emotional responses, 2. Difficulties engaging in goal directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to emotion regulation strategies, 6. Lack of emotional clarity Responses are on a 5-point scale: 1=almost never, 2=sometimes, 3=about half the time, 4=most of the time, 5=almost always
Measured: 12 months
Secondary outcomes (1)
Group x Time Interaction Amygdala Activity
0 to 12 month difference scores in group x time interaction amygdala activity
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startNov 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marianne Goodman, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467038
- Sponsor's protocol ID
- CDA-2-038-06F
- Status last verified
- Aug 2015
- First submitted
- 25 Apr 2007
- Last updated
- 25 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Goodman M, Carpenter D, Tang CY, Goldstein KE, Avedon J, Fernandez N, Mascitelli KA, Blair NJ, New AS, Triebwasser J, Siever LJ, Hazlett EA. Dialectical behavior therapy alters emotion regulation and amygdala activity in patients with borderline personality disorder. J Psychiatr Res. 2014 Oct;57:108-16. doi: 10.1016/j.jpsychires.2014.06.020. Epub 2014 Jul 2.
PubMed 25038629
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Aggression, Anger and Emotional Dysregulation in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT00467038
- Acronym / sponsor ID
- CDA-2-038-06F
- Conditions
- Borderline Personality Disorder
- Keywords
- affect, aggression, anger, behavior therapy, borderline personality disorder, MRI, functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Posted 25 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effects of 12 months of dialectical behavior therapy (DBT) for subjects with borderline personality disorder on aggression, anger and emotional dysregulation. Treatment effects will be measured by changes in interview, self-report, psychophysiology testing and fMRI neuroimaging.
Detailed description
Borderline Personality Disorder (BPD) is a disabling disorder characterized by poor affect regulation and poor impulse control. This often results in impaired interpersonal relationships and maladaptive behavioral patterns, including anger dyscontrol, aggression towards others and self-destructive behaviors. Evidence suggests that is a relatively common disorder, affecting 2% of the population 1. In addition, BPD patients have more frequent psychiatric hospitalizations, greater use of outpatient psychotherapy and more visits to the emergency room than individuals with any other psychiatric disorder 3, 4. Due to the heterogeneity of symptoms that fall under the DSM-IV definition of BPD, the most productive efforts to understand the underlying neurobiology of this disorder have employed a dimensional approach. This application focuses on the domain of affective instability and altered emotion regulation, believed by many to be at the core of the disorder 5.
The emotional dysregulation of BPD appears to be a biological vulnerability. This vulnerability includes both increased emotional reactivity, as well as an impaired capacity to employ effortful control in the modulation of emotional reactions. The emotional reactivity is manifested by high sensitivity to emotional stimuli and heightened emotional intensity5 and may reflect limbic system over activity. The impairment in emotional modulation results in a slow return to the baseline emotional state and may reflect deficits in prefrontal regulatory regions. While data supporting this formulation are limited, self-report measures of responses to various emotional stimuli and more recently, objective, non-verbal physiological measures including startle eye blink modulation (SEM), have been used to test this theory.
SEM is a well-established technique used to study the psychophysiology of emotion and has been shown to reflect amygdala activation6. Our research group has demonstrated exaggerated affective startle in BPD patients compared to healthy control subjects at later probe positions in response to words with emotionally negative valence, selected specifically to target emotions commonly unpleasant for BPD patients. Emerging neurobiological theories based on preliminary functional neuroimaging studies posit that BPD is a hyperarousal-dyscontrol syndrome 4, implicating dysfunction in amygdala activity coupled with weakening of prefrontal inhibitory control. Several neuroimaging studies from our research group have helped advance this idea7. Building on these exciting findings and the expertise available, this project uses a translational approach to study treatment effects on emotional regulation in BPD with SEM and prediction of treatment response with functional magnetic resonance imaging (fMRI).
Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD8, 9. It has gained considerable popularity and is included as a component of the APA guidelines for treatment of BPD10. While this approach stresses skills and techniques for emotional regulation, and encourages cognitive control over maladaptive behavioral patterns, there have been neither neuroimaging nor psychophysiological studies of the effect of DBT on emotional processing in BPD, despite its proven efficacy. While neuroimaging and psychophysiological studies of a psychotherapeutic treatment have been done in major depression 11, 12 13, no such studies have been done in BPD. By examining changes in affective startle and baseline predictors of response with fMRI blood oxygenation level dependent (BOLD) activation patterns associated with DBT treatment, this project aims to better characterize the nature of emotional dysregulation in BPD, and identify features that predict a good response to DBT treatment. In addition, the project will explore the relationship between clinical improvement of BPD symptomatology with DBT treatment and changes in neurobiological measures by performing follow-up SEM after six and twelve months of DBT treatment. This approach will help elucidate the neuroanatomy of abnormal emotional processing in BPD and may help identify potential strategies for correcting these deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavior Therapy | Other | Behavioral: Dialectical BehaviorDialectical Behavior Therapy |
| Healthy Controls | No intervention | –Healthy controls |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to provide written informed consent
- In good physical health as confirmed by a complete physical exam, electrocardiogram, neurological exam, and routine laboratory tests of blood and urine
- A negative urine toxicology screen
- Completion of psychiatric evaluations, medical evaluations, and self-report questionnaires through separate protocol- Biological Correlates of Personality Disorders (GCO #88-244)
Key exclusion criteria (8 listed)
- meet criteria for schizophrenia, bipolar I disorder, schizoaffective disorder or any other psychotic disorder.
- have met criteria for substance abuse or dependence during the 6 months prior to entry into the study
- have a past history of intravenous drug use, cocaine abuse or dependence, or any substance dependence that resulted in serious medical sequelae
- meet criteria for current MDE, as they may require antidepressant treatment
- have made a suicide attempt or had a psychiatric hospitalization during the 6 months prior to entry into the study
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 |
|---|---|---|
| Dialectical BehaviorDialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD | Behavioural | Dialectical Behavior Therapy |
Primary outcome
Self-Report of Difficulties in Emotion Regulation (DERS)
Time frame: 12 months
The present study examines DBT treatment effect on emotion regulation in unmedicated outpatients with BPD as measured by changes in the Difficulties in Emotion Regulation Scale. The DERS is a brief, 36-item, self-report questionnaire. DERS total score ranges from 36- 180. Higher scores reflect higher difficulties in emotion regulation. The measure yields a total score as well as scores on six scales derived through factor analysis: 1. Nonacceptance of emotional responses, 2. Difficulties engaging in goal directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to emotion regulation strategies, 6. Lack of emotional clarity Responses are on a 5-point scale: 1=almost never, 2=sometimes, 3=about half the time, 4=most of the time, 5=almost always
1 secondary outcome
Group x Time Interaction Amygdala Activity
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25038629Goodman M, Carpenter D, Tang CY, Goldstein KE, Avedon J, Fernandez N, Mascitelli KA, Blair NJ, New AS, Triebwasser J, Siever LJ, Hazlett EA. Dialectical behavior therapy alters emotion regulation and amygdala activity in patients with borderline personality disorder. J Psychiatr Res. 2014 Oct;57:108-16. doi: 10.1016/j.jpsychires.2014.06.020. Epub 2014 Jul 2.
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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.
Marianne Goodman, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior in people with Borderline Personality Disorder, run by US Department of Veterans Affairs 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 6 inclusion and 8 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 Aug 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. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-Report of Difficulties in Emotion Regulation (DERS) (time frame: 12 months). 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 NCT00467038, which also lists 1 linked publication.
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 Aug 2015.