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
- 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
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An fMRI Study of the Enhancement of Emotion Regulation in Borderline Patients
- ClinicalTrials.gov ID
- NCT02465697
- Acronym / sponsor ID
- GCO 05-1110
- Keywords
- Borderline Personality Disorder, Avoidant Personality Disorder, Brain Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BPD Emotion Regulation Training | Experimental | Behavioral: Reappraisal TrainingGuided practice in reappraisal |
| BPD Control | No intervention | –no training in reappraisal |
| APD Emotion Regulation Training | Experimental | Behavioral: Reappraisal TrainingGuided practice in reappraisal |
| APD Controls | No intervention | –no training in reappraisal |
| Healthy Controls Emotion Regulation Training | Experimental | Behavioral: Reappraisal TrainingGuided practice in reappraisal |
| Healthy Controls | No intervention | –no training in reappraisal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reappraisal TrainingAlso: Emotion Regulation Training | Behavioural | APD Emotion Regulation Training, BPD Emotion Regulation Training, Healthy Controls Emotion Regulation Training |
Primary outcome
Changes in BOLD signal in brain
Time frame: baseline and 5 days
BOLD signal changes at 5 days compared to baseline to measure reappraisal success using fMRI to record brain activity.
Changes in BOLD signal in brain
Time frame: baseline and 2 weeks
BOLD signal changes at 2 weeks compared to baseline to measure reappraisal success using fMRI to record brain activity.
4 secondary outcomes
Perceived Stress Scale
Time frame: baseline and 5 days
Perceived Stress Scale
Time frame: baseline and 2 weeks
State Trait Anger Expression Inventory (STAXI)
Time frame: baseline and 5 days
State Trait Anger Expression Inventory (STAXI)
Time frame: baseline and 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
Related trials for Borderline Personality Disorders
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Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
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Predictors of Clinical Course and Treatment Response in DBT Programmes
Self Harm, Borderline Personality Disorder
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Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold W Koenigsberg, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
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.