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RecruitingNCT06772831Updated Sep 9, 2026

Cognitive Reappraisal Training for Borderline Personality (BPD)

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

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Borderline Personality Disorder

Keywords

  • BPD
  • Treatment
  • fMRI
  • Cognitive Reappraisal
  • Emotion Regulation
  • Borderline Personality
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Cognitive Reappraisal-by-Distancing (CRD)

    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

  • Active comparator
    Downregulate Condition (CD)

    Patients will be coached to practice their customary emotion regulatory techniques in a treatment occurring twice a week for 6 weeks.

    Behavioral: Downregulate condition

Interventions

  • BehavioralCognitive Reappraisal by Distancing

    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.

  • BehavioralDownregulate condition

    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.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

06

Study locations

1 of 1 sites recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    • Harold W Koenigsberg · Principal investigator
    Recruiting
07

References and documents

Individual participant data

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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06772831
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
William Marsh Rice University, National Institute of Mental Health (NIMH)
Responsible party
Harold W Koenigsberg, MD (Professor of Psychiatry, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Jan 14, 2025
Start date
Nov 15, 2024
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Harold W Koenigsberg, MD
Contact
harold.koenigsberg@mssm.edu
718-584-9000 ext. 5757
Olivia Berin, BA
Contact
olivia.berin@mssm.edu
212-585-4649
Harold W Koenigsberg, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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