Clinical Trials Logo

Clinical 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.


Clinical Trial 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00467038
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase N/A
Start date November 2006
Completion date September 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Active, not recruiting NCT04587518 - Five Factor Model Treatment for Borderline Personality Disorder N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT03677037 - The Short-Term MBT Project Phase 3
Not yet recruiting NCT05989529 - Delving Into Borderline Personality Disorder Clinical Trial Experiences
Completed NCT02068326 - MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial N/A
Completed NCT02518906 - Evaluation of AIT Study N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Completed NCT02108990 - Acetaminophen and Social Processes Phase 2
Terminated NCT02149823 - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations Phase 1
Completed NCT01635556 - Evaluation of a Modified Dialectical Behavior Therapy Program N/A
Not yet recruiting NCT01683136 - Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder N/A
Completed NCT02988037 - Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study N/A
Completed NCT02397031 - Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder N/A
Terminated NCT01212588 - Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD) Phase 2
Terminated NCT01103180 - Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder Phase 2
Terminated NCT00539188 - N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD Phase 2
Recruiting NCT05398627 - Neurofeedback for Borderline Personality Disorder N/A
Recruiting NCT03994510 - SHame prOpensity in bOrderline Personality Disorder N/A
Recruiting NCT06005129 - Personality Change Study for Borderline Personality Disorder N/A