Borderline Personality DisorderNCT06772831
Cognitive Reappraisal Training for Borderline Personality (BPD)
A study testing Cognitive Reappraisal by Distancing and Downregulate condition in people with Borderline Personality Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Previous work by the group convinced the researchers to pursue development of focused cognitive reappraisal training as a novel approach to treatment of BPD, either as stand-alone treatment or in concert with evidence-based treatments of BPD. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Cognitive Reappraisal by Distancing and Downregulate condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Medically healthy men and women with Borderline Personality Disorder who are mentally competent and give informed voluntary written consent.
- Participants will be between the ages of 18 and 55.
- Within these requirements, the inclusion and exclusion criteria do not reflect participation based on gender or racial/ethnic group. The targeted/planned enrollment is a reflection of previous recruitment of female and ethnic minorities in other studies conducted by the PI and their colleagues and includes representations of both genders and all minorities.
- Participants with comorbid avoidant personality disorder will be included.
- Participants who meet criteria for PTSD will be included as long as they are not actively experiencing symptoms.
Who cannot join
- Participants will not meet criteria for Schizotypal Personality Disorder.
- Participants currently meeting criteria for Major Depressive Disorder will be excluded.
- BPD participants will not meet DSM-5 criteria for present PTSD, bipolar I disorder, schizophrenia, schizoaffective disorder, substance use disorder within the past 6 months, organic mental syndromes, head trauma, schizotypal personality disorder, avoidant personality disorder, CNS neurological disease, or seizure disorder. Participants meeting criteria for a non-IV substance use disorder more than 6 months prior to enrollment will not be excluded. This study allows patients who are currently taking psychotropic medications or are in psychotherapy, so long as there has been no change in medication or psychotherapy over the preceding two months.
- Participants currently meeting criteria for major depressive disorder.
- Participants meeting criteria for substance use disorder within the last 6 months or of an IV-substance use disorder at any time.
- Participants may not have a pacemaker, surgical clips, any metallic implants, or shrapnel fragments that would contraindicate MRI scanning.
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Harold W Koenigsberg
About this study
Official title: Cognitive Reappraisal Training Targeting Emotion Circuits As a Therapeutic Intervention in Borderline Patients
Previous work by the group convinced the researchers to pursue development of focused cognitive reappraisal training as a novel approach to treatment of BPD, either as stand-alone treatment or in concert with evidence-based treatments of BPD. The present proposal aims to refine and test a proposed clinical intervention for BPD patients, training in reappraisal-by-distancing, in terms of its ability to influence hypothesized neural and behavioral targets and, once that is established, to demonstrate its ability improve clinically relevant outcome measures.
Read the detailed description
Borderline Personality Disorder (BPD) is a prevalent, enduring and disabling psychiatric condition found in approximately 2% to 5.9% of the population and 20% of hospitalized psychiatric patients. Suicide rates of approximately 10% have been reported. One of the most prominent clinical features of BPD is extreme mood shifts occurring in response to external social/emotional events. The emotional instability in BPD contributes to many of the most disabling, even life-threatening, symptoms of the disorder, including suicidality, outbursts of intense anger, and seriously impaired role functioning. The severity of the BPD symptom profile, its prevalence, chronicity and high burden upon health care services make the development of effective and accessible treatment for BPD a high priority. Yet there is no current medication treatment indicated for BPD and the psychotherapies recognized for the disorder have been shown to have small effect sizes and are of limited availability. The present study builds upon work by the group that has shown that deficiencies in the ability to regulate emotion by engaging typically adaptive cognitive strategies (cognitive reappraisal, CR) and to effectively activate associated neural systems can be corrected by focused training in CR. The R61 phase of this study examines a manualized intensive training program in CR, tests that it effects target neural systems implicated in emotional processing and enhances behavioral reappraisal success. It examines 2-, 4- and 6- weeks of twice a week treatment to identify the optimal dose. Measures include fMRI imaging and clinical ratings at baseline and each of these subsequent time points. Upon demonstrating that CR training is superior to a control condition in enhancing performance in the neural target at one or more of these dose durations, the researchers will proceed to the R33 phase. In the R33 phase, the researchers will treat a larger sample of BPD patients at the optimal 6-week dose defined in the R61 phase to 1) demonstrate reproducibility of the R61 findings, 2) to demonstrate that CR training is superior to control in improving BPD clinical outcomes at the end of treatment and at 1- and 4- month follow-up, and 3) that change in activity at the neural targets is associated with clinical improvement. The results of this study can support the introduction of CR training as a new psychosocial approach for the treatment of BPD, either as stand-alone treatment or as an augmenting strategy. It may, moreover, have application to a range of psychiatric disorders characterized by severe emotional instability.
- Conditions
- Borderline Personality Disorder
- Being tested
- Cognitive Reappraisal by Distancing, Downregulate condition
- Keywords
- BPD, Treatment, fMRI, Cognitive Reappraisal, Emotion Regulation, Borderline Personality
- Medical subject headings
- Borderline Personality Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Reappraisal by DistancingBehavioural
Reappraisal-by-distancing treatment. Patients meet 2 times a week for 6 weeks to learn reappraisal by distancing through repeated practice with negative emotional pictures. The therapist will help model and shape the technique.
Downregulate conditionBehavioural
Patients either meet 2x a week for 6- weeks to gain added practice, under the guidance of a therapist, using their customary emotion regulatory strategies to downregulate their negative reactions to aversive pictures.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Reappraisal-by-Distancing (CRD) | Experimental | Patients will be coached to use cognitive reappraisal-by-distancing to downregulate their negative reactions to aversive emotional pictures using practice pictures. Receives: Behavioral: Cognitive Reappraisal by Distancing |
| Downregulate Condition (CD) | Active comparator | Patients will be coached to practice their customary emotion regulatory techniques in a treatment occurring twice a week for 6 weeks. Receives: Behavioral: Downregulate condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Picture Induced Negative Emotion Signature (PINES) Network Activity
Change in Picture Induced Negative Emotion Signature (PINES) network activity. by measuring neural activation using fMRI.
Measured: Baseline and 6 weeks of treatment
Secondary outcomes (6)
Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Score
A validated 9-item self-report scale that assesses the severity of borderline personality disorder symptoms across four sectors: affective, cognitive, impulsive, and interpersonal. Total scores range from 0-36, with higher scores indicating greater symptom severity. Each item is rated on a 5-point scale (0-4), where 0 indicates no symptoms and 4 indicates severe symptoms.
Measured: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in Active Lability Scale (ALS) Score
A 54-item self-report measure that assesses rapid changes in emotional states. Items are rated on a 4-point scale ranging from 0 ("very uncharacteristic of me") to 3 ("very characteristic of me"). Total scores range from 0-162, with higher scores indicating greater emotional instability.
Measured: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in Perceived Stress Scale (PSS)
A 10-item self-report measure that assesses the degree to which situations in one's life are appraised as stressful. Items are rated on a 5-point scale from 0 ("never") to 4 ("very often"). Total scores range from 0-40, with higher scores indicating greater perceived stress.
Measured: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in Difficulties in Emotion Regulation Scale (DERS) Scores
A 36-item self-report measure that assesses six dimensions of emotion regulation difficulties. Items are rated on a 5-point scale from 1 ("almost never") to 5 ("almost always"). Total scores range from 36-180, with higher scores indicating greater difficulties with emotion regulation.
Measured: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in Beck Depression Inventory (BDI) Score
A 21-item self-report measure that assesses the severity of depression symptoms. Items are rated on a 4-point scale from 0-3, with total scores ranging from 0-63. Higher scores indicate more severe depressive symptoms, with scores >13 suggesting clinically significant depression.
Measured: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in State-Trait Anxiety Inventory (STAXI) Score
A 40-item self-report measure that assesses both state anxiety (current anxiety level) and trait anxiety (general tendency to be anxious). Items are rated on a 4-point scale from 1 ("not at all") to 4 ("very much so"). Scores for each scale range from 20-80, with higher scores indicating greater anxiety levels.
Measured: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Nov 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the proposed study, the researchers will compare the effect of cognitive reappraisal training to a control condition in activating brain regions implicated in emotion regulation and in downregulating negative emotions. The researchers will further develop the treatment manual with BPD patients - treatment delivered 2 times a week for 6-weeks. All subjects will be seen for 6 weeks with the full battery of assessments, including fMRI imaging, carried out at baseline and the 6 week time points.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- William Marsh Rice University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Harold W Koenigsberg, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Harold W Koenigsberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772831
- Sponsor's protocol ID
- GCO 20-0432-00001-03
- Other IDs
- 4R33MH125130-03
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Reappraisal Training Targeting Emotion Circuits As a Therapeutic Intervention in Borderline Patients
- ClinicalTrials.gov ID
- NCT06772831
- Acronym / sponsor ID
- GCO 20-0432-00001-03
- Conditions
- Borderline Personality Disorder
- Keywords
- BPD, Treatment, fMRI, Cognitive Reappraisal, Emotion Regulation, Borderline Personality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- William Marsh Rice University, National Institute of Mental Health (NIMH)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- 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.
Previous work by the group convinced the researchers to pursue development of focused cognitive reappraisal training as a novel approach to treatment of BPD, either as stand-alone treatment or in concert with evidence-based treatments of BPD. The present proposal aims to refine and test a proposed clinical intervention for BPD patients, training in reappraisal-by-distancing, in terms of its ability to influence hypothesized neural and behavioral targets and, once that is established, to demonstrate its ability improve clinically relevant outcome measures.
Detailed description
Borderline Personality Disorder (BPD) is a prevalent, enduring and disabling psychiatric condition found in approximately 2% to 5.9% of the population and 20% of hospitalized psychiatric patients. Suicide rates of approximately 10% have been reported. One of the most prominent clinical features of BPD is extreme mood shifts occurring in response to external social/emotional events. The emotional instability in BPD contributes to many of the most disabling, even life-threatening, symptoms of the disorder, including suicidality, outbursts of intense anger, and seriously impaired role functioning. The severity of the BPD symptom profile, its prevalence, chronicity and high burden upon health care services make the development of effective and accessible treatment for BPD a high priority. Yet there is no current medication treatment indicated for BPD and the psychotherapies recognized for the disorder have been shown to have small effect sizes and are of limited availability. The present study builds upon work by the group that has shown that deficiencies in the ability to regulate emotion by engaging typically adaptive cognitive strategies (cognitive reappraisal, CR) and to effectively activate associated neural systems can be corrected by focused training in CR. The R61 phase of this study examines a manualized intensive training program in CR, tests that it effects target neural systems implicated in emotional processing and enhances behavioral reappraisal success. It examines 2-, 4- and 6- weeks of twice a week treatment to identify the optimal dose. Measures include fMRI imaging and clinical ratings at baseline and each of these subsequent time points. Upon demonstrating that CR training is superior to a control condition in enhancing performance in the neural target at one or more of these dose durations, the researchers will proceed to the R33 phase. In the R33 phase, the researchers will treat a larger sample of BPD patients at the optimal 6-week dose defined in the R61 phase to 1) demonstrate reproducibility of the R61 findings, 2) to demonstrate that CR training is superior to control in improving BPD clinical outcomes at the end of treatment and at 1- and 4- month follow-up, and 3) that change in activity at the neural targets is associated with clinical improvement. The results of this study can support the introduction of CR training as a new psychosocial approach for the treatment of BPD, either as stand-alone treatment or as an augmenting strategy. It may, moreover, have application to a range of psychiatric disorders characterized by severe emotional instability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the proposed study, the researchers will compare the effect of cognitive reappraisal training to a control condition in activating brain regions implicated in emotion regulation and in downregulating negative emotions. The researchers will further develop the treatment manual with BPD patients - treatment delivered 2 times a week for 6-weeks. All subjects will be seen for 6 weeks with the full battery of assessments, including fMRI imaging, carried out at baseline and the 6 week time points.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Reappraisal-by-Distancing (CRD) | Experimental | Behavioral: Cognitive Reappraisal by DistancingPatients will be coached to use cognitive reappraisal-by-distancing to downregulate their negative reactions to aversive emotional pictures using practice pictures. |
| Downregulate Condition (CD) | Active comparator | Behavioral: Downregulate conditionPatients will be coached to practice their customary emotion regulatory techniques in a treatment occurring twice a week for 6 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medically healthy men and women with Borderline Personality Disorder who are mentally competent and give informed voluntary written consent.
- Participants will be between the ages of 18 and 55.
- Within these requirements, the inclusion and exclusion criteria do not reflect participation based on gender or racial/ethnic group. The targeted/planned enrollment is a reflection of previous recruitment of female and ethnic minorities in other studies conducted by the PI and their colleagues and includes representations of both genders and all minorities.
- Participants with comorbid avoidant personality disorder will be included.
- Participants who meet criteria for PTSD will be included as long as they are not actively experiencing symptoms.
Key exclusion criteria (7 listed)
- Participants will not meet criteria for Schizotypal Personality Disorder.
- Participants currently meeting criteria for Major Depressive Disorder will be excluded.
- BPD participants will not meet DSM-5 criteria for present PTSD, bipolar I disorder, schizophrenia, schizoaffective disorder, substance use disorder within the past 6 months, organic mental syndromes, head trauma, schizotypal personality disorder, avoidant personality disorder, CNS neurological disease, or seizure disorder. Participants meeting criteria for a non-IV substance use disorder more than 6 months prior to enrollment will not be excluded. This study allows patients who are currently taking psychotropic medications or are in psychotherapy, so long as there has been no change in medication or psychotherapy over the preceding two months.
- Participants currently meeting criteria for major depressive disorder.
- Participants meeting criteria for substance use disorder within the last 6 months or of an IV-substance use disorder at any time.
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 |
|---|---|---|
| Cognitive Reappraisal by DistancingReappraisal-by-distancing treatment. Patients meet 2 times a week for 6 weeks to learn reappraisal by distancing through repeated practice with negative emotional pictures. The therapist will help model and shape the technique. | Behavioural | Cognitive Reappraisal-by-Distancing (CRD) |
| Downregulate conditionPatients either meet 2x a week for 6- weeks to gain added practice, under the guidance of a therapist, using their customary emotion regulatory strategies to downregulate their negative reactions to aversive pictures. | Behavioural | Downregulate Condition (CD) |
Primary outcome
Change in Picture Induced Negative Emotion Signature (PINES) Network Activity
Time frame: Baseline and 6 weeks of treatment
Change in Picture Induced Negative Emotion Signature (PINES) network activity. by measuring neural activation using fMRI.
6 secondary outcomes
Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Score
Time frame: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in Active Lability Scale (ALS) Score
Time frame: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in Perceived Stress Scale (PSS)
Time frame: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in Difficulties in Emotion Regulation Scale (DERS) Scores
Time frame: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in Beck Depression Inventory (BDI) Score
Time frame: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Change in State-Trait Anxiety Inventory (STAXI) Score
Time frame: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
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 Cognitive Reappraisal by Distancing and Downregulate condition in people with Borderline Personality Disorder, 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 7 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harold W Koenigsberg, MD (718-584-9000 ext. 5757, harold.koenigsberg@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Picture Induced Negative Emotion Signature (PINES) Network Activity (time frame: Baseline and 6 weeks of treatment). 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 9 Sep 2026.