Trial Outcomes & Findings for Treatment of Aggression, Anger and Emotional Dysregulation in Borderline Personality Disorder (NCT NCT00467038)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

12 months

Results posted on

2015-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Dialectical Behavior Therapy Participants receiving Dialectical Behavior Therapy	Healthy Controls Healthy controls- no intervention
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dialectical Behavior Therapy n=11 Participants 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 n=11 Participants Healthy controls Age and gender matched healthy volunteers	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.8 years STANDARD_DEVIATION 11.5 • n=5 Participants	30.4 years STANDARD_DEVIATION 10.4 • n=7 Participants	31.6 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 22 age- and gender-matched unmedicated BPD and HC participants (11 in each group).

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

Outcome measures

Outcome measures
Measure	Dialectical Behavior Therapy n=11 Participants 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 n=11 Participants Healthy controls age- and gender-matched to other group of participants
Self-Report of Difficulties in Emotion Regulation (DERS) 12 month	101.5 units on a scale Standard Deviation 25.7	54.8 units on a scale Standard Deviation 14.4
Self-Report of Difficulties in Emotion Regulation (DERS) Baseline	120.5 units on a scale Standard Deviation 24.2	56.6 units on a scale Standard Deviation 14.9

SECONDARY outcome

Timeframe: Baseline and 12 months

0 to 12 month difference scores in group x time interaction amygdala activity

Outcome measures

Outcome measures
Measure	Dialectical Behavior Therapy n=11 Participants 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 n=11 Participants Healthy controls age- and gender-matched to other group of participants
Group x Time Interaction Amygdala Activity	-11.54 bold signal units Standard Deviation 11.73	16.67 bold signal units Standard Deviation 1.99

Adverse Events

Arm 1

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=11 participants at risk 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	Arm 2 n=11 participants at risk Healthy controls- no intervention
Psychiatric disorders Psychiatric hospitalization after suicidal ideation and unsafe behavior	9.1% 1/11 • 4 years, between 2007 and 2010	0.00% 0/11 • 4 years, between 2007 and 2010

Other adverse events

Other adverse events
Measure	Arm 1 n=11 participants at risk 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	Arm 2 n=11 participants at risk Healthy controls- no intervention
General disorders Vertebrae fracture due to fall	9.1% 1/11 • 4 years, between 2007 and 2010	0.00% 0/11 • 4 years, between 2007 and 2010
Social circumstances Arrest due to armed robbery	9.1% 1/11 • 4 years, between 2007 and 2010	0.00% 0/11 • 4 years, between 2007 and 2010
General disorders Excessive drinking and unsafe sex	9.1% 1/11 • 4 years, between 2007 and 2010	0.00% 0/11 • 4 years, between 2007 and 2010
Psychiatric disorders Superficial cut as deliberate self-harm	9.1% 1/11 • 4 years, between 2007 and 2010	0.00% 0/11 • 4 years, between 2007 and 2010
Psychiatric disorders Superficial scratching as deliberate self-harm	9.1% 1/11 • 4 years, between 2007 and 2010	0.00% 0/11 • 4 years, between 2007 and 2010
Psychiatric disorders Treatment for eating disorder	9.1% 1/11 • 4 years, between 2007 and 2010	0.00% 0/11 • 4 years, between 2007 and 2010
General disorders Anxiety and dizziness during fMRI scan	9.1% 1/11 • 4 years, between 2007 and 2010	0.00% 0/11 • 4 years, between 2007 and 2010

Additional Information

Marianne Goodman, MD

James J Peters VAMC

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place