Cognitive Reappraisal Training for Borderline Personality

Borderline Personality Disorder Clinical Trial

— BPD  

Official title:

Cognitive Reappraisal Training Targeting Emotion Circuits As a Therapeutic Intervention in Borderline Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967222
• Other study ID #: GCO 20-0432-01001
• Secondary ID: R61MH125130
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Harold W Koenigsberg, MD
• Phone: 718-584-9000
• Email: harold.koenigsberg[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Cognitive Reappraisal by Distancing
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. .
• Control Downregulate Condition
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH), William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PINES Network activity	Change in Picture Induced Negative Emotion Signature (PINES) network activity. by measuring neural activation using fMRI.	Baseline and up to 6 weeks of treatment
Primary	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.	Baseline and up to 6 weeks of treatment
Secondary	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	Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Secondary	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.	Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Secondary	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	Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Secondary	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.	Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Secondary	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.	Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Secondary	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.	Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.