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Cognitive Reappraisal Training for Borderline Personality (BPD)

Primary Purpose

Borderline Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Reappraisal by Distancing
Control Downregulate Condition
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring BPD, Treatment, fMRI, cognitive reappraisal, Borderline Personality Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Medically healthy men and women with Borderline Personality Disorder who are mentally competent and give informed voluntary written consent.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Reappraisal-by-Distancing (CRD)

Control Downregulate Condition (CD)

Arm Description

Subjects will be coached to use cognitive reappraisal-by-distancing to downregulate their negative reactions to aversive emotional pictures usng practice pictures.

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

Outcomes

Primary Outcome Measures

Change in PINES Network activity
Change in Picture Induced Negative Emotion Signature (PINES) network activity. by measuring neural activation using fMRI.
Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)
Zanarini Rating Scale for Borderline Personality, self-report. Full scale from from 0-36. Higher score indicates poorer health outcomes.

Secondary Outcome Measures

Change in ZAN-BPD sector scores
There are three affective symptoms in the ZAN-BPD (with a sector score ranging from 0-12): inappropriate anger/frequent angry acts, mood instability, and chronic feelings of emptiness. There are two cognitive symptoms (with a sector score ranging from 0-8): stress-related paranoia/dissociation and severe identity disturbance. (Identity disturbance was placed in the cognitive realm because it is based on a series of false beliefs or overvalued ideas, such as that one is a bad person.) There are also two impulsive symptoms (with a sector score ranging from 0-8): self-mutilative/suicidal efforts and at least two other forms of impulsivity. Finally, there are two symptoms in the interpersonal realm of BPD (with a sector score ranging from 0-8): frantic efforts of avoid abandonment and intense, unstable relationships. The four sector scores sum to provide a total score of borderline psychopathology, which ranges from 0-36. Higher score indicates poorer health outcomes
Change in Affective Lability Scale total (ALS)
The ALS-SF consists of 18 items which are rated on a four-point Likert scale ranging from 0 ("very uncharacteristic of me") to 3 ("very characteristic of me"). Five of the items refer to shifts in anxiety/depression, eight refer to shifts in depression/elation, and the final five items concern shifts between anger and normal mood. The scale yields a total score of AL (the sum of all item responses divided by 18), as well as subscores for the three affective domains. Total score range from 0 to 54, with higher score indicating more affective lability.
Change in Perceived Stress Scale (PSS)
Perceive Stress Scale (PSS) - A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress. the more often the person perceives stress
Change in Difficulty in Emotion Regulation Scale Scores (DERS)
Difficulties in emotion regulation scale (DERS) The DERS is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 (" almost never [0-10%] ") to 5 (" almost always [91-100%] "). Total scale from 6-216. Higher scores indicate more difficulty in emotion regulation.
Change in Beck Depression Scale score (BDI)
The Beck Depression Inventory (BDI) is used to evaluate depression symptoms. This questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
Change in State-Trait Anxiety Scale Score (STAXI)
A 40 self-report items questionnaire, each item scored on 4-point likert-type response scale from 1 (not at all) to 4 (almost always), full range from 20 to 80, with higher score STAI scores suggesting higher levels of anxiety.

Full Information

First Posted
July 8, 2021
Last Updated
May 20, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
William Marsh Rice University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04967222
Brief Title
Cognitive Reappraisal Training for Borderline Personality
Acronym
BPD
Official Title
Cognitive Reappraisal Training Targeting Emotion Circuits As a Therapeutic Intervention in Borderline Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
William Marsh Rice University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 study 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 study team will proceed to the R33 phase. In the R33 phase the study team will treat a larger sample of BPD patients at the optimal 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
BPD, Treatment, fMRI, cognitive reappraisal, Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Reappraisal-by-Distancing (CRD)
Arm Type
Experimental
Arm Description
Subjects will be coached to use cognitive reappraisal-by-distancing to downregulate their negative reactions to aversive emotional pictures usng practice pictures.
Arm Title
Control Downregulate Condition (CD)
Arm Type
Active Comparator
Arm Description
Subjects will be coached to practice their customary emotion regulatory techniques in a treatment occurring twice a week for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Reappraisal by Distancing
Other Intervention Name(s)
CRD
Intervention Description
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. .
Intervention Type
Behavioral
Intervention Name(s)
Control Downregulate Condition
Other Intervention Name(s)
CD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PINES Network activity
Description
Change in Picture Induced Negative Emotion Signature (PINES) network activity. by measuring neural activation using fMRI.
Time Frame
Baseline and up to 6 weeks of treatment
Title
Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)
Description
Zanarini Rating Scale for Borderline Personality, self-report. Full scale from from 0-36. Higher score indicates poorer health outcomes.
Time Frame
Baseline and up to 6 weeks of treatment
Secondary Outcome Measure Information:
Title
Change in ZAN-BPD sector scores
Description
There are three affective symptoms in the ZAN-BPD (with a sector score ranging from 0-12): inappropriate anger/frequent angry acts, mood instability, and chronic feelings of emptiness. There are two cognitive symptoms (with a sector score ranging from 0-8): stress-related paranoia/dissociation and severe identity disturbance. (Identity disturbance was placed in the cognitive realm because it is based on a series of false beliefs or overvalued ideas, such as that one is a bad person.) There are also two impulsive symptoms (with a sector score ranging from 0-8): self-mutilative/suicidal efforts and at least two other forms of impulsivity. Finally, there are two symptoms in the interpersonal realm of BPD (with a sector score ranging from 0-8): frantic efforts of avoid abandonment and intense, unstable relationships. The four sector scores sum to provide a total score of borderline psychopathology, which ranges from 0-36. Higher score indicates poorer health outcomes
Time Frame
Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Title
Change in Affective Lability Scale total (ALS)
Description
The ALS-SF consists of 18 items which are rated on a four-point Likert scale ranging from 0 ("very uncharacteristic of me") to 3 ("very characteristic of me"). Five of the items refer to shifts in anxiety/depression, eight refer to shifts in depression/elation, and the final five items concern shifts between anger and normal mood. The scale yields a total score of AL (the sum of all item responses divided by 18), as well as subscores for the three affective domains. Total score range from 0 to 54, with higher score indicating more affective lability.
Time Frame
Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Title
Change in Perceived Stress Scale (PSS)
Description
Perceive Stress Scale (PSS) - A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress. the more often the person perceives stress
Time Frame
Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Title
Change in Difficulty in Emotion Regulation Scale Scores (DERS)
Description
Difficulties in emotion regulation scale (DERS) The DERS is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 (" almost never [0-10%] ") to 5 (" almost always [91-100%] "). Total scale from 6-216. Higher scores indicate more difficulty in emotion regulation.
Time Frame
Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Title
Change in Beck Depression Scale score (BDI)
Description
The Beck Depression Inventory (BDI) is used to evaluate depression symptoms. This questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
Time Frame
Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Title
Change in State-Trait Anxiety Scale Score (STAXI)
Description
A 40 self-report items questionnaire, each item scored on 4-point likert-type response scale from 1 (not at all) to 4 (almost always), full range from 20 to 80, with higher score STAI scores suggesting higher levels of anxiety.
Time Frame
Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Medically healthy men and women with Borderline Personality Disorder who are mentally competent and give informed voluntary written consent. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harold W Koenigsberg, MD
Phone
718-584-9000
Ext
5757
Email
harold.koenigsberg@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Edward C Foran, BA
Phone
212-241-9775 ext 0442
Email
edward.foran@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold Koenigsberg, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward C Foran
Phone
212-241-9775
Ext
0442
Email
edward.foran@mssm.edu
First Name & Middle Initial & Last Name & Degree
Harold W Koenigsberg, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 identified for this purpose. For individual participant data meta-analysis.

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Cognitive Reappraisal Training for Borderline Personality

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