Cognitive Reappraisal Training for Borderline Personality (BPD)

NCT06772831 | Recruiting DMC

• 2 other identifiers: GCO 20-0432-00001-034R33MH125130-03
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Borderline Personality Disorder

Keywords

BPD; Treatment; fMRI; Cognitive Reappraisal; Emotion Regulation; Borderline Personality

Outcome Measures

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.

  Baseline and 6 weeks of treatment

Secondary Outcomes (6)

• Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Score

  Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up

• Change in Active Lability Scale (ALS) Score

  Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up

• Change in Perceived Stress Scale (PSS)

  Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up

• Change in Difficulties in Emotion Regulation Scale (DERS) Scores

  Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up

• Change in Beck Depression Inventory (BDI) Score

  Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-up

Study Arms (2)

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.

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.

Behavioral: Downregulate condition

Interventions

Cognitive Reappraisal by Distancing BEHAVIORAL

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.

Cognitive Reappraisal-by-Distancing (CRD)

Downregulate condition BEHAVIORAL

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.

Downregulate Condition (CD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• William Marsh Rice University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Harold W Koenigsberg, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harold W Koenigsberg, MD

CONTACT

718-584-9000; harold.koenigsberg@mssm.edu

Brian B Kang, BA

CONTACT

212-241-9775; brian.kang@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: November 15, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)