Borderline Personality DisorderBPDNCT04967222
Cognitive Reappraisal Training for Borderline Personality
A study testing Cognitive Reappraisal by Distancing 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 study group convinced the study team 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Subjects who are being treated with psychotherapy or psychopharmacotherapy will be included so long as there has been no change in that treatment over the preceding 2 months.
Who cannot join
- Age > 55
- Criteria for Schizotypal Personality Disorder or Avoidant Personality Disorder. SPD is excluded to avoid possible confound from the restricted affect that characterizes SPD and co-morbid AvPD subjects will be excluded because the researchers have shown that their patterns of neural activity in emotion processing are distinct from BPD subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10024
About this study
Official title: Cognitive Reappraisal Training Targeting Emotion Circuits As a Therapeutic Intervention in Borderline Patients
Previous work by the study group convinced the study team 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 study 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 study team will proceed to the R33 phase. In the R33 phase the study team will treat a larger sample of BPD patients at the optimal 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, Control Downregulate Condition
- Keywords
- BPD, Treatment, fMRI, cognitive reappraisal, Borderline Personality Disorder
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Reappraisal by DistancingBehavioural
Also called CRD
Reappraisal-by-distancing treatment. Participants 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. .
Control Downregulate ConditionBehavioural
Also called CD
Participants 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 | Subjects will be coached to use cognitive reappraisal-by-distancing to downregulate their negative reactions to aversive emotional pictures usng practice pictures. Receives: Behavioral: Cognitive Reappraisal by Distancing |
| Control Downregulate Condition (CD) | Active comparator | Subjects will be coached to practice their customary emotion regulatory techniques in a treatment occurring twice a week for 6 weeks. Receives: Behavioral: Control Downregulate Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PINES Network Activity
BOLD signal change in Picture Induced Negative Emotion Signature (PINES) network activity that includes the amygdala, insula, and other regions by measuring neural activation using fMRI.
Measured: Baseline and up to 6 weeks of treatment
Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)
Zanarini Rating Scale for Borderline Personality, self-report. Full scale from 0-36. Higher score indicates poorer health outcomes.
Measured: Baseline and up to 6 weeks of treatment
Secondary outcomes (6)
Change in ZAN-BPD Sector Scores
There are three affective symptoms in the ZAN-BPD (with a sector score ranging from 0-12): inappropriate anger/frequent angry acts, mood instability, and chronic feelings of emptiness. There are two cognitive symptoms (with a sector score ranging from 0-8): stress-related paranoia/dissociation and severe identity disturbance. (Identity disturbance was placed in the cognitive realm because it is based on a series of false beliefs or overvalued ideas, such as that one is a bad person.) There are also two impulsive symptoms (with a sector score ranging from 0-8): self-mutilative/suicidal efforts and at least two other forms of impulsivity. Finally, there are two symptoms in the interpersonal realm of BPD (with a sector score ranging from 0-8): frantic efforts of avoid abandonment and intense, unstable relationships. The four sector scores sum to provide a total score of borderline psychopathology, which ranges from 0-36. Higher score indicates poorer health outcomes
Measured: Baseline and at 2-,4-, and 6-weeks
Change in Affective Lability Scale Total (ALS)
The Affective Lability Scale (ALS) consists of 54 items which are rated on a four-point Likert scale ranging from 0 ("very uncharacteristic of me") to 3 ("very characteristic of me"). Five of the items refer to shifts in anxiety/depression, eight refer to shifts in depression/elation, and the final five items concern shifts between anger and normal mood. The scale yields a total score of ALS, as well as subscores for the three affective domains. Total score range from 0 to 162, with higher score indicating more affective lability.
Measured: Baseline and at 2-,4-, and 6-weeks
Change in Perceived Stress Scale (PSS)
Perceive Stress Scale (PSS) - A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress or the more often the person perceives stress.
Measured: Baseline and at 2-,4-, and 6-weeks
Change in Difficulty in Emotion Regulation Scale Scores (DERS)
Difficulties in emotion regulation scale (DERS) The DERS is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 (" almost never [0-10%] ") to 5 (" almost always [91-100%] "). Total scale from 6-216. Higher scores indicate more difficulty in emotion regulation.
Measured: Baseline and at 2-,4-, and 6-weeks
Change in Beck Depression Scale Score (BDI)
The Beck Depression Inventory (BDI) is used to evaluate depression symptoms. This questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
Measured: Baseline and at 2-,4-, and 6-weeks
Change in State-Trait Anxiety Scale Score (STAXI)
A 40 self-report items questionnaire, each item scored on 4-point likert-type response scale from 1 (not at all) to 4 (almost always), full range from 40 to 160, with higher score suggesting higher levels of anxiety.4
Measured: Baseline and at 2-,4-, and 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Dec 2021
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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 Koenigsberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967222
- Sponsor's protocol ID
- GCO 20-0432-01001
- Other IDs
- R61MH125130
- Acronym
- BPD
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2021
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Aug 2025. 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
- NCT04967222
- Acronym / sponsor ID
- BPD / GCO 20-0432-01001
- Conditions
- Borderline Personality Disorder
- Keywords
- BPD, Treatment, fMRI, cognitive reappraisal, Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- 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
- 1 Dec 2021 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Posted 5 Aug 2025
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 study group convinced the study team 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 study 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 study team will proceed to the R33 phase. In the R33 phase the study team will treat a larger sample of BPD patients at the optimal 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
| Arm | Type | Receives |
|---|---|---|
| Cognitive Reappraisal-by-Distancing (CRD) | Experimental | Behavioral: Cognitive Reappraisal by DistancingSubjects will be coached to use cognitive reappraisal-by-distancing to downregulate their negative reactions to aversive emotional pictures usng practice pictures. |
| Control Downregulate Condition (CD) | Active comparator | Behavioral: Control Downregulate ConditionSubjects 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 (2 listed)
- Medically healthy men and women with Borderline Personality Disorder who are mentally competent and give informed voluntary written consent.
- Subjects who are being treated with psychotherapy or psychopharmacotherapy will be included so long as there has been no change in that treatment over the preceding 2 months.
Key exclusion criteria (2 listed)
- Age > 55
- Criteria for Schizotypal Personality Disorder or Avoidant Personality Disorder. SPD is excluded to avoid possible confound from the restricted affect that characterizes SPD and co-morbid AvPD subjects will be excluded because the researchers have shown that their patterns of neural activity in emotion processing are distinct from BPD subjects.
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 DistancingAlso: CRDReappraisal-by-distancing treatment. Participants 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) |
| Control Downregulate ConditionAlso: CDParticipants 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 | Control Downregulate Condition (CD) |
Primary outcome
Change in PINES Network Activity
Time frame: Baseline and up to 6 weeks of treatment
BOLD signal change in Picture Induced Negative Emotion Signature (PINES) network activity that includes the amygdala, insula, and other regions by measuring neural activation using fMRI.
Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)
Time frame: Baseline and up to 6 weeks of treatment
Zanarini Rating Scale for Borderline Personality, self-report. Full scale from 0-36. Higher score indicates poorer health outcomes.
6 secondary outcomes
Change in ZAN-BPD Sector Scores
Time frame: Baseline and at 2-,4-, and 6-weeks
Change in Affective Lability Scale Total (ALS)
Time frame: Baseline and at 2-,4-, and 6-weeks
Change in Perceived Stress Scale (PSS)
Time frame: Baseline and at 2-,4-, and 6-weeks
Change in Difficulty in Emotion Regulation Scale Scores (DERS)
Time frame: Baseline and at 2-,4-, and 6-weeks
Change in Beck Depression Scale Score (BDI)
Time frame: Baseline and at 2-,4-, and 6-weeks
Change in State-Trait Anxiety Scale Score (STAXI)
Time frame: Baseline and at 2-,4-, and 6-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Harold 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 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 2 inclusion and 2 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 5 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in PINES Network Activity (time frame: Baseline and up to 6 weeks of treatment). 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 5 Aug 2025.