Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467038
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2007-04-25
Brief Title:
Treatment of Aggression Anger and Emotional Dysregulation in Borderline Personality Disorder
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Treatment of Aggression Anger and Emotional Dysregulation in Borderline Personality Disorder
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None