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Trial record 44 of 607 for:    Personality Disorders

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

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ClinicalTrials.gov Identifier: NCT00467038
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : August 25, 2015
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dialectical Behavior Therapy Healthy Controls
Hide Arm/Group Description Participants receiving Dialectical Behavior Therapy Healthy controls- no intervention
Period Title: Overall Study
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Dialectical Behavior Therapy Healthy Controls Total
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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

Age and gender matched healthy volunteers

Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
11
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
32.8  (11.5) 30.4  (10.4) 31.6  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
9
  81.8%
9
  81.8%
18
  81.8%
Male
2
  18.2%
2
  18.2%
4
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Self-Report of Difficulties in Emotion Regulation (DERS)
Hide Description

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

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
22 age- and gender-matched unmedicated BPD and HC participants (11 in each group).
Arm/Group Title Dialectical Behavior Therapy Healthy Controls
Hide Arm/Group Description:

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

Healthy controls age- and gender-matched to other group of participants
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
12 month 101.5  (25.7) 54.8  (14.4)
Baseline 120.5  (24.2) 56.6  (14.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dialectical Behavior Therapy, Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.004
Comments [Not Specified]
Method t-test, 1 sided
Comments <0.004 p value was common for all time points.
2.Secondary Outcome
Title Group x Time Interaction Amygdala Activity
Hide Description 0 to 12 month difference scores in group x time interaction amygdala activity
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dialectical Behavior Therapy Healthy Controls
Hide Arm/Group Description:
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
Healthy controls age- and gender-matched to other group of participants
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: bold signal units
-11.54  (11.73) 16.67  (1.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dialectical Behavior Therapy, Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Fisher's LSD post-hoc, trend level
Comments [Not Specified]
Time Frame 4 years, between 2007 and 2010
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

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

Healthy controls- no intervention
All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/11 (0.00%)    
Psychiatric disorders     
Psychiatric hospitalization after suicidal ideation and unsafe behavior * 1  1/11 (9.09%)  0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, IND Safety reporting
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/11 (63.64%)      0/11 (0.00%)    
General disorders     
Vertebrae fracture due to fall * 1  1/11 (9.09%)  0/11 (0.00%) 
Excessive drinking and unsafe sex * 1  1/11 (9.09%)  0/11 (0.00%) 
Anxiety and dizziness during fMRI scan * 1  1/11 (9.09%)  0/11 (0.00%) 
Psychiatric disorders     
Superficial cut as deliberate self-harm * 1  1/11 (9.09%)  0/11 (0.00%) 
Superficial scratching as deliberate self-harm * 1  1/11 (9.09%)  0/11 (0.00%) 
Treatment for eating disorder * 1  1/11 (9.09%)  0/11 (0.00%) 
Social circumstances     
Arrest due to armed robbery * 1  1/11 (9.09%)  0/11 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, IND Safety reporting
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.
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
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
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