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.
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
- Conditions the study is for
- Borderline Personality Disorders, Avoidant Personality Disorders
- What is being tested?
- Reappraisal Training
- Type of treatment
- Lifestyle or therapy programme
- 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
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
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 group | Role | What they receive |
|---|---|---|
| BPD Emotion Regulation Training | Experimental | Guided practice in reappraisal Receives: Behavioral: Reappraisal Training |
| BPD Control | No intervention | no training in reappraisal |
| APD Emotion Regulation Training | Experimental | Guided practice in reappraisal Receives: Behavioral: Reappraisal Training |
| APD Controls | No intervention | no training in reappraisal |
| Healthy Controls Emotion Regulation Training | Experimental | Guided practice in reappraisal Receives: Behavioral: Reappraisal Training |
| Healthy Controls | No intervention | no training in reappraisal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Perceived Stress Scale
Change in Perceived Stress Scale at 5 days compared to baseline
Measured: baseline and 5 days
Perceived Stress Scale
Change in Perceived Stress Scale at 2 weeks compared to baseline
Measured: baseline and 2 weeks
State Trait Anger Expression Inventory (STAXI)
Change in STAXI at 5 days compared to baseline
Measured: baseline and 5 days
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.
- First posted8 Jun 2015 (estimated)
- Study startSep 2011
- Primary completion21 Sep 2017
- Study completion21 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisordersStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold W Koenigsberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
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