Changes in the Brain as Borderline Patients Learn to Regulate Their Emotions
Primary Purpose
Borderline Personality Disorders, Avoidant Personality Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reappraisal Training
Sponsored by
About this trial
This is an interventional basic science trial for Borderline Personality Disorders focused on measuring Borderline Personality Disorder, Avoidant Personality Disorder, Brain Imaging
Eligibility Criteria
Inclusion Criteria:
- BPD subjects 18 to 50 years old
- Meet criteria for DSM-IV Borderline Personality Disorder, including the DSM-IV criteria for affective instability (criterion #6), and not meet criteria for Schizotypal Personality Disorder (SPD) or AvPD.
- Subjects in the AvPD group meet DSM-IV criteria for AvPD and not for BPD or SPD.
- All subjects will be free of psychotropic medications for 2 weeks (6 weeks for fluoxetine).
- Subjects may be enrolled in psychotherapy
Exclusion Criteria:
- BPD and AvPD subjects will not meet DSM-IV criteria for past or present PTSD, bipolar I disorder, schizophrenia, schizoaffective disorder, substance dependence, head trauma, CNS neurological disease, seizure disorder or current major depression.
- Substance abuse disorder in the prior 6 months
- Significant medical illness
- Pregnancy
- Metallic foreign-bodies that contraindicate MRI
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Arm Label
BPD Emotion Regulation Training
BPD Control
APD Emotion Regulation Training
APD Controls
Healthy Controls Emotion Regulation Training
Healthy Controls
Arm Description
Guided practice in reappraisal
no training in reappraisal
Guided practice in reappraisal
no training in reappraisal
Guided practice in reappraisal
no training in reappraisal
Outcomes
Primary Outcome Measures
Changes in BOLD signal in brain
BOLD signal changes at 5 days compared to baseline to measure reappraisal success using fMRI to record brain activity.
Changes in BOLD signal in brain
BOLD signal changes at 2 weeks compared to baseline to measure reappraisal success using fMRI to record brain activity.
Secondary Outcome Measures
Perceived Stress Scale
Change in Perceived Stress Scale at 5 days compared to baseline
Perceived Stress Scale
Change in Perceived Stress Scale at 2 weeks compared to baseline
State Trait Anger Expression Inventory (STAXI)
Change in STAXI at 5 days compared to baseline
State Trait Anger Expression Inventory (STAXI)
Change in STAXI at 2 weeks compared to baseline
Full Information
NCT ID
NCT02465697
First Posted
June 4, 2015
Last Updated
October 27, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT02465697
Brief Title
Changes in the Brain as Borderline Patients Learn to Regulate Their Emotions
Official Title
An fMRI Study of the Enhancement of Emotion Regulation in Borderline Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
September 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Borderline Personality Disorder (BPD), a prevalent psychiatric disorder found in approximately 2% to 6% of the population and 20% of hospitalized psychiatric patients, has proven quite treatment resistant. This study is designed to determine whether patients with BPD can be trained to improve their ability to regulate their emotions and whether this leads to changes in how their brans regulate emotion.
Detailed Description
Borderline Personality Disorder (BPD) is a common psychiatric disorder found in approximately 2% to 6% of the population . It is characterized by intense and rapid mood changes, self-destructive behavior, suicidality, and tumultuous relationships. In additional to the emotional costs of the suffering experienced by borderline patients and their loved ones, BPD patients typically function at a level substantially below that of individuals with comparable intellect. The difficulty controlling emotion, so central to the disorder, has proved a particularly difficult to treat. The present study utilizes the latest neuroimaging findings in BPD to generate new ideas for the psychotherapy of the disorder.
This project builds upon our previous neuroimaging work, which has shown that when BPD patients try to control their emotions by employing a method that healthy people frequently use quite effectively -- taking an emotional distance from what is upsetting - BPD patients are not able to quiet down the part of their brain that sends out emotional alarm signals. The objective of the present study is to determine whether giving BPD patients special training in using this healthy distancing strategy can help them to improve their ability to regulate their emotions and return their brain activity to a more normal pattern. The investigators will do this by using fMRI to record brain activity as BPD subjects try to use distancing to reduce their emotional reactions to upsetting pictures before any training, then to have them receive specific training in the distancing strategy. After this training we will again obtain an fMRI scan to determine whether their pattern of brain activation has normalized and whether they have been able to better reduce their negative reactions to the pictures. If this is effective, it will show that such training may help BPD patients better regulate their emotions and would support a program to further develop and incorporate distancing training into the psychotherapy of BPD patients.
A second objective of the present study is to determine whether the tendency of BPD patients to become increasingly sensitized to negative situations when they are re-experienced (as shown by increased activity of the brain's emotional alarm system), will reduce with additional exposure, as it does in patients with phobias, or will continue to increase. Knowing this can help the therapist plan how to most therapeutically approach disturbing life experiences in the psychotherapy of BPD patients.
This project represents an important step in brain imaging research since it applies information learned about brain activity patterns to develop new approaches to psychotherapy. It addresses a serious, prevalent and difficult to treat disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorders, Avoidant Personality Disorders
Keywords
Borderline Personality Disorder, Avoidant Personality Disorder, Brain Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BPD Emotion Regulation Training
Arm Type
Experimental
Arm Description
Guided practice in reappraisal
Arm Title
BPD Control
Arm Type
No Intervention
Arm Description
no training in reappraisal
Arm Title
APD Emotion Regulation Training
Arm Type
Experimental
Arm Description
Guided practice in reappraisal
Arm Title
APD Controls
Arm Type
No Intervention
Arm Description
no training in reappraisal
Arm Title
Healthy Controls Emotion Regulation Training
Arm Type
Experimental
Arm Description
Guided practice in reappraisal
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
no training in reappraisal
Intervention Type
Behavioral
Intervention Name(s)
Reappraisal Training
Other Intervention Name(s)
Emotion Regulation Training
Primary Outcome Measure Information:
Title
Changes in BOLD signal in brain
Description
BOLD signal changes at 5 days compared to baseline to measure reappraisal success using fMRI to record brain activity.
Time Frame
baseline and 5 days
Title
Changes in BOLD signal in brain
Description
BOLD signal changes at 2 weeks compared to baseline to measure reappraisal success using fMRI to record brain activity.
Time Frame
baseline and 2 weeks
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
Change in Perceived Stress Scale at 5 days compared to baseline
Time Frame
baseline and 5 days
Title
Perceived Stress Scale
Description
Change in Perceived Stress Scale at 2 weeks compared to baseline
Time Frame
baseline and 2 weeks
Title
State Trait Anger Expression Inventory (STAXI)
Description
Change in STAXI at 5 days compared to baseline
Time Frame
baseline and 5 days
Title
State Trait Anger Expression Inventory (STAXI)
Description
Change in STAXI at 2 weeks compared to baseline
Time Frame
baseline and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BPD subjects 18 to 50 years old
Meet criteria for DSM-IV Borderline Personality Disorder, including the DSM-IV criteria for affective instability (criterion #6), and not meet criteria for Schizotypal Personality Disorder (SPD) or AvPD.
Subjects in the AvPD group meet DSM-IV criteria for AvPD and not for BPD or SPD.
All subjects will be free of psychotropic medications for 2 weeks (6 weeks for fluoxetine).
Subjects may be enrolled in psychotherapy
Exclusion Criteria:
BPD and AvPD subjects will not meet DSM-IV criteria for past or present PTSD, bipolar I disorder, schizophrenia, schizoaffective disorder, substance dependence, head trauma, CNS neurological disease, seizure disorder or current major depression.
Substance abuse disorder in the prior 6 months
Significant medical illness
Pregnancy
Metallic foreign-bodies that contraindicate MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold W Koenigsberg, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Changes in the Brain as Borderline Patients Learn to Regulate Their Emotions
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