An interventional study of Cognitive Reappraisal by Distancing and Downregulate condition in Borderline Personality Disorder, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
Among 81 studies in Borderline Personality Disorder with a site in United States — 15 open to participants now, 17 under way, none of them phase 3. Borderline Personality Disorder · United States.
Among the 81 studies in Borderline Personality Disorder with a site in United States, this one is the 14th largest by planned enrollment of the 71 interventional ones, is one of 6 that started in 2024, is one of 39 with no phase, reaches primary completion later than 10 of the 16 other live ones, and was the 75th registered.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
This study's planned enrollment of 130 is above the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Browse Borderline Personality Disorder studies →15 of the 81 studies in Borderline Personality Disorder with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →81 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 6 started in 2024.
Median enrollment 56 across the 71 interventional studies, 48 across the 7 observational. Of the 57 that completed or were terminated, 22 (39%) have results posted.
9 of 81 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 5 studies filed under Borderline Personality Disorder — fewer than ten, so there is no comparison to draw.
7 of the studies in Borderline Personality Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04870255Stanford UniversityTreatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS | 2026-12 |
| NCT05651295Matthew Southward, PhDA Precision Medicine Approach to Target Engagement for Emotion Regulation | 2026-12-31 |
| NCT06683014Yale UniversityMDMA in Borderline Personality Disorder | 2027-06 |
| NCT07460947Mclean HospitalA Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder | 2027-06 |
| NCT06772831Icahn School of Medicine at Mount SinaiCognitive Reappraisal Training for Borderline Personality (BPD) | 2027-07-31 |
Among the 81 studies in Borderline Personality Disorder with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be coached to use cognitive reappraisal-by-distancing to downregulate their negative reactions to aversive emotional pictures using practice pictures.
Behavioral: Cognitive Reappraisal by Distancing
Patients will be coached to practice their customary emotion regulatory techniques in a treatment occurring twice a week for 6 weeks.
Behavioral: Downregulate condition
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.
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.
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.
Time frame: Baseline and 6 weeks of treatment
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis.
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Jul 2027, 32 months after the start.
Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's planned 32 months is close to that.
Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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