Treatment of Aggression, Anger and Emotional Dysregulation in Borderline Personality Disorder

NCT00467038 | Completed Results

• 1 other identifier: CDA-2-038-06F
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

affect; aggression; anger; behavior therapy; borderline personality disorder; MRI, functional

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Group x Time Interaction Amygdala Activity

  Baseline and 12 months

Study Arms (2)

Dialectical Behavior Therapy

OTHER

Dialectical Behavior Therapy

Behavioral: Dialectical Behavior

Healthy Controls

NO INTERVENTION

Healthy controls

Interventions

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

Dialectical Behavior Therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• 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.

  PMID: 25038629 RESULT

MeSH Terms

Conditions

Borderline Personality Disorder; Aggression

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

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.

Results Point of Contact

• Title: Marianne Goodman, MD
• Organization: James J Peters VAMC

marianne.goodman@va.gov

718-584-9000

Study Officials

• Marianne Goodman, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: November 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 25, 2015
• Results First Posted: August 25, 2015

Record last verified: 2015-08

Locations

US (1)