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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02465697
Other study ID # GCO 05-1110
Secondary ID
Status Completed
Phase N/A
First received June 4, 2015
Last updated October 27, 2017
Start date September 2011
Est. completion date September 21, 2017

Study information

Verified date October 2017
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 169
Est. completion date September 21, 2017
Est. primary completion date September 21, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Intervention

Behavioral:
Reappraisal Training


Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline and 5 days
Primary 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. baseline and 2 weeks
Secondary Perceived Stress Scale Change in Perceived Stress Scale at 5 days compared to baseline baseline and 5 days
Secondary Perceived Stress Scale Change in Perceived Stress Scale at 2 weeks compared to baseline baseline and 2 weeks
Secondary State Trait Anger Expression Inventory (STAXI) Change in STAXI at 5 days compared to baseline baseline and 5 days
Secondary State Trait Anger Expression Inventory (STAXI) Change in STAXI at 2 weeks compared to baseline baseline and 2 weeks
See also
  Status Clinical Trial Phase
Unknown status NCT01033708 - A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder N/A
Recruiting NCT05972096 - DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder N/A