Cognitive Reappraisal Training for Borderline Personality

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04967222

Acronym

BPD

Enrollment

Registered

2021-07-19

Start date

2021-12-01

Completion date

2024-06-03

Last updated

2025-08-05

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, Borderline Personality Disorder

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.

Interventions

BEHAVIORALCognitive 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. .

BEHAVIORALControl 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in PINES Network Activity	Baseline and up to 6 weeks of treatment	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.
Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)	Baseline and up to 6 weeks of treatment	Zanarini Rating Scale for Borderline Personality, self-report. Full scale from 0-36. Higher score indicates poorer health outcomes.

Secondary

Measure	Time frame	Description
Change in Perceived Stress Scale (PSS)	Baseline and at 2-,4-, and 6-weeks	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 or the more often the person perceives stress.
Change in Difficulty in Emotion Regulation Scale Scores (DERS)	Baseline and at 2-,4-, and 6-weeks	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 ZAN-BPD Sector Scores	Baseline and at 2-,4-, and 6-weeks	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 State-Trait Anxiety Scale Score (STAXI)	Baseline and at 2-,4-, and 6-weeks	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 40 to 160, with higher score suggesting higher levels of anxiety.4
Change in Beck Depression Scale Score (BDI)	Baseline and at 2-,4-, and 6-weeks	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 Affective Lability Scale Total (ALS)	Baseline and at 2-,4-, and 6-weeks	The Affective Lability Scale (ALS) consists of 54 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 ALS, as well as subscores for the three affective domains. Total score range from 0 to 162, with higher score indicating more affective lability.

Countries

United States

Participant flow

Recruitment details

60 participants consented. After preliminary screening visits, 26 participants were randomized.

Participants by arm

Arm	Count
Cognitive Reappraisal-by-Distancing (CRD) Subjects will be coached to use cognitive reappraisal-by-distancing to downregulate their negative reactions to aversive emotional pictures using practice pictures. 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.	13
Control Downregulate Condition (CD) Subjects will be coached to practice their customary emotion regulatory techniques in a treatment occurring twice a week for 6 weeks. 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.	13
Total	26

Withdrawals & dropouts

Period	Reason	FG001	FG002
Randomized	abnormal finding in MRI	2	0
Randomized	Lost to Follow-up	1	1
Randomized	Physician Decision	0	1
Randomized	Withdrawal by Subject	0	2

Baseline characteristics

Characteristic	Control Downregulate Condition (CD)	Total	Cognitive Reappraisal-by-Distancing (CRD)
Age, Continuous	30.46 years STANDARD_DEVIATION 9.22	30.77 years STANDARD_DEVIATION 8.52	31.08 years STANDARD_DEVIATION 8.14
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	3 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants	23 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	6 Participants	4 Participants
Race (NIH/OMB) Black or African American	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) White	8 Participants	14 Participants	6 Participants
Sex: Female, Male Female	12 Participants	24 Participants	12 Participants
Sex: Female, Male Male	1 Participants	2 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 13	0 / 13
other Total, other adverse events	0 / 13	0 / 13
serious Total, serious adverse events	0 / 13	0 / 13

Outcome results

Primary

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.

Time frame: Baseline and up to 6 weeks of treatment

Population: Data available for participants who had procedure

Arm	Measure	Group	Value (MEAN)	Dispersion
Cognitive Reappraisal-by-Distancing (CRD)	Change in PINES Network Activity	after up to 6 weeks of treatment	0.12 BOLD Signal	Standard Deviation 0.04
Cognitive Reappraisal-by-Distancing (CRD)	Change in PINES Network Activity	baseline	0.15 BOLD Signal	Standard Deviation 0.04
Control Downregulate Condition (CD)	Change in PINES Network Activity	baseline	0.14 BOLD Signal	Standard Deviation 0.03
Control Downregulate Condition (CD)	Change in PINES Network Activity	after up to 6 weeks of treatment	012 BOLD Signal	Standard Deviation 0.06

Primary

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.

Time frame: Baseline and up to 6 weeks of treatment

Population: Data available for participants who completed instrument.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cognitive Reappraisal-by-Distancing (CRD)	Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)	Baseline	15.22 score on a scale	Standard Deviation 7.7
Cognitive Reappraisal-by-Distancing (CRD)	Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)	after up to 6 weeks of treatment	10 score on a scale	Standard Deviation 9.52
Control Downregulate Condition (CD)	Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)	Baseline	12.86 score on a scale	Standard Deviation 5.7
Control Downregulate Condition (CD)	Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)	after up to 6 weeks of treatment	9.38 score on a scale	Standard Deviation 6.19

Secondary

Change in Affective Lability Scale Total (ALS)

The Affective Lability Scale (ALS) consists of 54 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 ALS, as well as subscores for the three affective domains. Total score range from 0 to 162, with higher score indicating more affective lability.