- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02465697
Changes in the Brain as Borderline Patients Learn to Regulate Their Emotions
An fMRI Study of the Enhancement of Emotion Regulation in Borderline Patients
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BPD Emotion Regulation Training
Guided practice in reappraisal
|
Other Names:
|
No Intervention: BPD Control
no training in reappraisal
|
|
Experimental: APD Emotion Regulation Training
Guided practice in reappraisal
|
Other Names:
|
No Intervention: APD Controls
no training in reappraisal
|
|
Experimental: Healthy Controls Emotion Regulation Training
Guided practice in reappraisal
|
Other Names:
|
No Intervention: Healthy Controls
no training in reappraisal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in BOLD signal in brain
Time Frame: baseline and 5 days
|
BOLD signal changes at 5 days compared to baseline to measure reappraisal success using fMRI to record brain activity.
|
baseline and 5 days
|
Changes in BOLD signal in brain
Time Frame: baseline and 2 weeks
|
BOLD signal changes at 2 weeks compared to baseline to measure reappraisal success using fMRI to record brain activity.
|
baseline and 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale
Time Frame: baseline and 5 days
|
Change in Perceived Stress Scale at 5 days compared to baseline
|
baseline and 5 days
|
Perceived Stress Scale
Time Frame: baseline and 2 weeks
|
Change in Perceived Stress Scale at 2 weeks compared to baseline
|
baseline and 2 weeks
|
State Trait Anger Expression Inventory (STAXI)
Time Frame: baseline and 5 days
|
Change in STAXI at 5 days compared to baseline
|
baseline and 5 days
|
State Trait Anger Expression Inventory (STAXI)
Time Frame: baseline and 2 weeks
|
Change in STAXI at 2 weeks compared to baseline
|
baseline and 2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Harold W Koenigsberg, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 05-1110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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