NCT04967222

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 5, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

July 8, 2021

Results QC Date

June 4, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

BPDTreatmentfMRIcognitive reappraisalBorderline Personality Disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and up to 6 weeks of treatment

Secondary Outcomes (6)

  • Change in ZAN-BPD Sector Scores

    Baseline and at 2-,4-, and 6-weeks

  • Change in Affective Lability Scale Total (ALS)

    Baseline and at 2-,4-, and 6-weeks

  • Change in Perceived Stress Scale (PSS)

    Baseline and at 2-,4-, and 6-weeks

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

    Baseline and at 2-,4-, and 6-weeks

  • Change in Beck Depression Scale Score (BDI)

    Baseline and at 2-,4-, and 6-weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Control Downregulate Condition

Interventions

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. .

Also known as: CRD
Cognitive Reappraisal-by-Distancing (CRD)

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.

Also known as: CD
Control Downregulate Condition (CD)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10024, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Results Point of Contact

Title
Dr. Harold W Koenigsberg
Organization
Icahn School of Medicine at Mount Sinai

Study Officials

  • Harold Koenigsberg, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 19, 2021

Study Start

December 1, 2021

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

August 5, 2025

Results First Posted

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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 identified for this purpose. For individual participant data meta-analysis.

Locations