Clinical trial NCT02465697: 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
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorders
Avoidant Personality Disorders
Keywords: Borderline Personality Disorder
Avoidant Personality Disorder
Brain Imaging
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Changes in BOLD signal in brain
timeFrame: baseline and 5 days
measure: Changes in BOLD signal in brain
timeFrame: baseline and 2 weeks
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: baseline and 5 days
measure: Perceived Stress Scale
timeFrame: baseline and 2 weeks
measure: State Trait Anger Expression Inventory (STAXI)
timeFrame: baseline and 5 days
measure: State Trait Anger Expression Inventory (STAXI)
timeFrame: baseline and 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Harold W Koenigsberg, MD
role: PRINCIPAL_INVESTIGATOR
References: