N/A
N=22
Treatment of Aggression, Anger and Emotional Dysregulation in Borderline Personality Disorder
Borderline Personality Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00467038 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Aug 2015
Primary outcome: Primary: Self-Report of Difficulties in Emotion Regulation (DERS) — 101.5; 54.8; 120.5; 56.6 units on a scale — p=<0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dialectical Behavior (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Report of Difficulties in Emotion Regulation (DERS) |
101.5; 54.8; 120.5; 56.6 | <0.004 sig |
| SECONDARY Group x Time Interaction Amygdala Activity |
-11.54; 16.67 | 0.08 |
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.
Eligibility Criteria
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)
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00467038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.