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

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: April 25, 2007
Last updated: August 20, 2015
Last verified: August 2015
Results First Received: November 24, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Borderline Personality Disorder
Intervention: Behavioral: Dialectical Behavior

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Dialectical Behavior Therapy Participants receiving Dialectical Behavior Therapy
Healthy Controls Healthy controls- no intervention

Participant Flow:   Overall Study
    Dialectical Behavior Therapy     Healthy Controls  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  

  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
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.

Healthy Controls

Healthy controls

Age and gender matched healthy volunteers

Total Total of all reporting groups

Baseline Measures
    Dialectical Behavior Therapy     Healthy Controls     Total  
Number of Participants  
[units: participants]
  11     11     22  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     11     11     22  
>=65 years     0     0     0  
[units: years]
Mean (Standard Deviation)
  32.8  (11.5)     30.4  (10.4)     31.6  (11)  
[units: participants]
Female     9     9     18  
Male     2     2     4  
Region of Enrollment  
[units: participants]
United States     11     11     22  

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Self-Report of Difficulties in Emotion Regulation (DERS)   [ Time Frame: 12 months ]

2.  Secondary:   Group x Time Interaction Amygdala Activity   [ Time Frame: Baseline and 12 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Marianne Goodman, MD
Organization: James J Peters VAMC
phone: 718-584-9000 ext 5188

Publications of Results:

Responsible Party: VA Office of Research and Development Identifier: NCT00467038     History of Changes
Other Study ID Numbers: CDA-2-038-06F
Study First Received: April 25, 2007
Results First Received: November 24, 2014
Last Updated: August 20, 2015
Health Authority: United States: Federal Government