Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialectical Behavior Therapy | Other | Dialectical Behavior Therapy |
|
| Healthy Controls | No Intervention | Healthy controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialectical Behavior | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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: 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Group x Time Interaction Amygdala Activity | 0 to 12 month difference scores in group x time interaction amygdala activity | Baseline and 12 months |
Not provided
Inclusion Criteria:
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)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marianne Goodman, MD | VA Medical Center, Bronx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Bronx | The Bronx | New York | 10468 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25038629 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dialectical Behavior Therapy | Participants receiving Dialectical Behavior Therapy |
| FG001 | Healthy Controls | Healthy controls- no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dialectical Behavior Therapy | Dialectical Behavior Therapy Dialectical Behavior: 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 Event-related fMRI was obtained pre- and post-12-months of standard-DBT in unmedicatedBPD patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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: 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 | 22 age- and gender-matched unmedicated BPD and HC participants (11 in each group). | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
4 years, between 2007 and 2010
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Dialectical Behavior Therapy Dialectical Behavior: 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric hospitalization after suicidal ideation and unsafe behavior | Psychiatric disorders | IND Safety reporting | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertebrae fracture due to fall | General disorders | IND Safety reporting | Non-systematic Assessment |
Small community sample. Additionally, our emotional task was a "passive viewing task" which means that we did not examine "active" emotion regulation, per se which might be considered a study limitation by some. No comparison treatment group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Goodman, MD | James J Peters VAMC | 718-584-9000 | 5188 | marianne.goodman@va.gov |
Not provided
| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077252 | Dialectical Behavior Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG001 |
| Healthy Controls |
Healthy controls Age and gender matched healthy volunteers |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dialectical Behavior Therapy |
Dialectical Behavior Therapy Dialectical Behavior: 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 |
| OG001 | Healthy Controls | Healthy controls age- and gender-matched to other group of participants |
|
|
|
| Secondary | Group x Time Interaction Amygdala Activity | 0 to 12 month difference scores in group x time interaction amygdala activity | Posted | Mean | Standard Deviation | bold signal units | Baseline and 12 months |
|
|
|
|
| 1 |
| 11 |
| 7 |
| 11 |
| EG001 | Arm 2 | Healthy controls- no intervention | 0 | 11 | 0 | 11 |
| Arrest due to armed robbery | Social circumstances | IND Safety reporting | Non-systematic Assessment |
|
| Excessive drinking and unsafe sex | General disorders | IND Safety reporting | Non-systematic Assessment |
|
| Superficial cut as deliberate self-harm | Psychiatric disorders | IND Safety reporting | Non-systematic Assessment |
|
| Superficial scratching as deliberate self-harm | Psychiatric disorders | IND Safety reporting | Non-systematic Assessment |
|
| Treatment for eating disorder | Psychiatric disorders | IND Safety reporting | Non-systematic Assessment |
|
| Anxiety and dizziness during fMRI scan | General disorders | IND Safety reporting | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D001519 | Behavior |
| D012919 | Social Behavior |