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Cognitive Reappraisal Training for Borderline Personality (BPD)

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06772831
Enrollment
130
Registered
2025-01-14
Start date
2024-11-15
Completion date
2027-07-31
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Keywords

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

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.

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.

Interventions

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.

BEHAVIORALDownregulate 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.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER
William Marsh Rice University
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Picture Induced Negative Emotion Signature (PINES) Network ActivityBaseline and 6 weeks of treatmentChange in Picture Induced Negative Emotion Signature (PINES) network activity. by measuring neural activation using fMRI.

Secondary

MeasureTime frameDescription
Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) ScoreBaseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-upA 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.
Change in Active Lability Scale (ALS) ScoreBaseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-upA 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.
Change in Perceived Stress Scale (PSS)Baseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-upA 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.
Change in Difficulties in Emotion Regulation Scale (DERS) ScoresBaseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-upA 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.
Change in Beck Depression Inventory (BDI) ScoreBaseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-upA 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.
Change in State-Trait Anxiety Inventory (STAXI) ScoreBaseline, 6 weeks of treatment, 1-month follow-up, and 4-month follow-upA 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.

Countries

United States

Contacts

CONTACTHarold W Koenigsberg, MD
harold.koenigsberg@mssm.edu718-584-9000
CONTACTOlivia Berin, BA
olivia.berin@mssm.edu212-585-4649
PRINCIPAL_INVESTIGATORHarold W Koenigsberg, MD

Icahn School of Medicine at Mount Sinai

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026