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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467038
First Posted: April 27, 2007
Last Update Posted: August 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: November 24, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Borderline Personality Disorder
Intervention: Behavioral: Dialectical Behavior

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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
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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.
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Reporting Groups
  Description
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 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   11   22 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.8  (11.5)   30.4  (10.4)   31.6  (11) 
Gender 
[Units: Participants]
     
Female   9   9   18 
Male   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   11   11   22 


  Outcome Measures
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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
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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
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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
e-mail: marianne.goodman@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00467038     History of Changes
Other Study ID Numbers: CDA-2-038-06F
First Submitted: April 25, 2007
First Posted: April 27, 2007
Results First Submitted: November 24, 2014
Results First Posted: August 25, 2015
Last Update Posted: August 25, 2015