Changes in the Brain as Borderline Patients Learn to Regulate Their Emotions

October 27, 2017 updated by: Icahn School of Medicine at Mount Sinai

An fMRI Study of the Enhancement of Emotion Regulation in Borderline Patients

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.

Study Overview

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

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Emotion Regulation Training
No Intervention: BPD Control
no training in reappraisal
Experimental: APD Emotion Regulation Training
Guided practice in reappraisal
Other Names:
  • Emotion Regulation Training
No Intervention: APD Controls
no training in reappraisal
Experimental: Healthy Controls Emotion Regulation Training
Guided practice in reappraisal
Other Names:
  • Emotion Regulation Training
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Harold W Koenigsberg, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 21, 2017

Study Completion (Actual)

September 21, 2017

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

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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