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Borderline Personality DisordersNCT02465697

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

A study testing Reappraisal Training in people with Borderline Personality Disorders and Avoidant Personality Disorders, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Reappraisal Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
1 siteUnited States
Study dates
Sep 2011to 21 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Reappraisal Training
Keywords
Borderline Personality Disorder, Avoidant Personality Disorder, Brain Imaging
Medical subject headings
Borderline Personality Disorder, Personality Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reappraisal TrainingBehavioural

    Also called Emotion Regulation Training

Study groups in NCT02465697
Study groupRoleWhat they receive
BPD Emotion Regulation TrainingExperimentalGuided practice in reappraisal
Receives: Behavioral: Reappraisal Training
BPD ControlNo interventionno training in reappraisal
APD Emotion Regulation TrainingExperimentalGuided practice in reappraisal
Receives: Behavioral: Reappraisal Training
APD ControlsNo interventionno training in reappraisal
Healthy Controls Emotion Regulation TrainingExperimentalGuided practice in reappraisal
Receives: Behavioral: Reappraisal Training
Healthy ControlsNo interventionno training in reappraisal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and 5 days

  2. 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.

    Measured: baseline and 2 weeks

Secondary outcomes (4)
  1. Perceived Stress Scale

    Change in Perceived Stress Scale at 5 days compared to baseline

    Measured: baseline and 5 days

  2. Perceived Stress Scale

    Change in Perceived Stress Scale at 2 weeks compared to baseline

    Measured: baseline and 2 weeks

  3. State Trait Anger Expression Inventory (STAXI)

    Change in STAXI at 5 days compared to baseline

    Measured: baseline and 5 days

  4. State Trait Anger Expression Inventory (STAXI)

    Change in STAXI at 2 weeks compared to baseline

    Measured: baseline and 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study startSep 2011
  3. Primary completion21 Sep 2017
  4. Study completion21 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465697
Sponsor's protocol ID
GCO 05-1110
Status last verified
Oct 2017
First submitted
4 Jun 2015
Last updated
31 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Reappraisal Training in people with Borderline Personality Disorders and Avoidant Personality Disorders, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in BOLD signal in brain (time frame: baseline and 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.

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