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

NCT ID: NCT02465697

Last Updated: 2017-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2017-09-21

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.

Conditions

Borderline Personality Disorders; Avoidant Personality Disorders

Keywords

Borderline Personality Disorder; Avoidant Personality Disorder; Brain Imaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

BPD Emotion Regulation Training

Guided practice in reappraisal

Group Type: EXPERIMENTAL

Reappraisal Training

Intervention Type: BEHAVIORAL

BPD Control

no training in reappraisal

Group Type: NO_INTERVENTION

No interventions assigned to this group

APD Emotion Regulation Training

Guided practice in reappraisal

Group Type: EXPERIMENTAL

Reappraisal Training

Intervention Type: BEHAVIORAL

APD Controls

no training in reappraisal

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Controls Emotion Regulation Training

Guided practice in reappraisal

Group Type: EXPERIMENTAL

Reappraisal Training

Intervention Type: BEHAVIORAL

Healthy Controls

no training in reappraisal

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reappraisal Training

Intervention Type: BEHAVIORAL

Other Intervention Names

Emotion Regulation Training

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harold W Koenigsberg, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 05-1110

Identifier Type: -

Identifier Source: org_study_id