Clinical trial NCT04967222: Cognitive Reappraisal Training for Borderline Personality
Official title: Cognitive Reappraisal Training Targeting Emotion Circuits As a Therapeutic Intervention in Borderline Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: BPD
Treatment
fMRI
cognitive reappraisal
Borderline Personality Disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: William Marsh Rice University
name: National Institute of Mental Health (NIMH)
First posted: 2021-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in PINES Network activity
timeFrame: Baseline and up to 6 weeks of treatment
measure: Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)
timeFrame: Baseline and up to 6 weeks of treatment
Secondary outcomes:
measure: Change in ZAN-BPD sector scores
timeFrame: Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
measure: Change in Affective Lability Scale total (ALS)
timeFrame: Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
measure: Change in Difficulty in Emotion Regulation Scale Scores (DERS)
timeFrame: Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
measure: Change in Beck Depression Scale score (BDI)
timeFrame: Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
measure: Change in State-Trait Anxiety Scale Score (STAXI)
timeFrame: Baseline and at 2-,4-, and 6-weeks and 1 and 4 months after treatment ends.
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Harold Koenigsberg, MD
role: PRINCIPAL_INVESTIGATOR
References: