Cognitive Reappraisal Training for Borderline Personality (BPD)

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.

Study Overview

• Status: Recruiting
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Cognitive Reappraisal by Distancing; Behavioral: Downregulate condition

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 Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harold W Koenigsberg, MD; Phone Number: 5757 718-584-9000; Email: harold.koenigsberg@mssm.edu
• Study Contact Backup: Name: Brian B Kang, BA; Phone Number: 212-241-9775; Email: brian.kang@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Harold W Koenigsberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 6 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Mental Health (NIMH); William Marsh Rice University
• Investigators: Principal Investigator: Harold W Koenigsberg, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Treatment; fMRI; Emotion Regulation; BPD; Cognitive Reappraisal; Borderline Personality
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Behavior; Social Behavior; Self-Control; Borderline Personality Disorder; Emotional Regulation
• Other Study ID Numbers: GCO 20-0432-00001-03; 4R33MH125130-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No