Cognitive Reappraisal Training for Borderline Personality Disorder

(BPD Trial)

Overseen By Edward C Foran, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Age > 55, Schizotypal, Avoidant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with Borderline Personality Disorder (BPD) manage their emotions more effectively. It tests a technique called Cognitive Reappraisal by Distancing, which teaches participants to alter their reactions to negative situations. The trial compares this approach to standard emotional management strategies. Individuals with BPD who have not changed their therapy or medication in the last two months may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance emotional management strategies for BPD.

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications, as long as there has been no change in your treatment in the last 2 months.

What prior data suggests that this cognitive reappraisal training is safe for treating Borderline Personality Disorder?

Research shows that cognitive reappraisal training, including a technique called reappraisal-by-distancing, offers a promising way to help people with Borderline Personality Disorder (BPD) manage their emotions. Although specific safety data is limited, this approach involves changing how individuals think about and react to emotional situations. As a type of talk therapy rather than medication, it typically results in fewer physical side effects.

Previous studies have examined cognitive reappraisal in conditions like major depressive disorder and BPD, both related to emotion management. These studies suggest that cognitive reappraisal methods are generally well-tolerated. Since this is not a drug treatment, side effects are less likely and usually involve feelings or reactions during therapy rather than physical symptoms.

Overall, while specific safety details for this trial may be incomplete, cognitive reappraisal is considered a safe option for many. Participants learn new ways of thinking, which can lead to fewer negative emotional reactions without the risks associated with medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Reappraisal by Distancing (CRD) for Borderline Personality Disorder because it offers a fresh approach to managing emotional reactions. Unlike traditional treatments that often involve medication or extensive therapy sessions, CRD focuses on teaching individuals to mentally distance themselves from negative situations, helping them downregulate emotions more effectively. This technique empowers patients to actively reshape their emotional responses, potentially leading to quicker and more sustainable emotional regulation without the side effects associated with medications.

What evidence suggests that this trial's treatments could be effective for Borderline Personality Disorder?

Research shows that learning to rethink negative thoughts can help people with Borderline Personality Disorder (BPD) manage their emotions better. In this trial, participants will join one of two groups. One group will receive Cognitive Reappraisal-by-Distancing (CRD) training, which studies have shown helps people with BPD feel less negative and achieve more balanced brain activity. This training teaches them to handle emotions in a healthier way. The other group will participate in a Control Downregulate Condition (CD), practicing their customary emotion regulatory techniques. These findings suggest that the Cognitive Reappraisal-by-Distancing approach could effectively treat BPD. ^{6 7 8 9 10}

Who Is on the Research Team?

Harold Koenigsberg, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for medically healthy adults with Borderline Personality Disorder who can provide informed consent. It's not open to individuals over 55 or those with Schizotypal Personality Disorder or Avoidant Personality Disorder, due to their distinct neural activity patterns.

Inclusion Criteria

I am healthy, have Borderline Personality Disorder, and can consent to treatment.

I am healthy, have Borderline Personality Disorder, and can consent to treatment.

Exclusion Criteria

You have been diagnosed with Schizotypal Personality Disorder or Avoidant Personality Disorder. This is because people with these disorders may affect the accuracy of the study results.

I am older than 55.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive reappraisal training twice a week for 2, 4, or 6 weeks to identify the optimal dose

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 and 4 months

4 months

Open-label extension (optional)

Participants may opt into continuation of cognitive reappraisal training long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Reappraisal by Distancing
• Control Downregulate Condition

Trial Overview

The study tests a new treatment approach called cognitive reappraisal training by distancing. This method could be used alone or alongside other treatments for BPD, aiming to improve emotional regulation and influence behavior.

How Is the Trial Designed?

Group I: Cognitive Reappraisal-by-Distancing (CRD) Experimental Treatment 1 Intervention

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

Group II: Control Downregulate Condition (CD) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

William Marsh Rice University

Collaborator

Trials

50

Recruited

28,400+

Published Research Related to This Trial

A pilot study involving 29 adolescents with Borderline Personality Disorder (BPD) traits showed that those with higher BPD traits believed emotions to be fixed, leading to increased rumination and decreased cognitive reappraisal.

After a single virtual reality intervention aimed at changing beliefs about emotions, participants reported a greater belief in the changeability of their emotions, suggesting that modifying these beliefs could be beneficial in treating adolescents with BPD traits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Borderline Personality Traits and Emotion Regulation Strategies in Adolescents: The Role of Implicit Theories. McLachlan, J., Mehdikhani, M., Larham, B., et al.[2022]

Metacognitive therapy (MCT) was found to be a feasible treatment for patients with Borderline Personality Disorder, with all 12 participants completing the program and most maintaining follow-up assessments over two years.

Significant improvements were observed in borderline symptoms, interpersonal issues, and trauma symptoms from the start of treatment to the two-year follow-up, suggesting that MCT could be an effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive Therapy of Early Traumatized Patients With Borderline Personality Disorder: A Phase-II Baseline Controlled Trial. Nordahl, HM., Wells, A.[2023]

Metacognitive training for borderline personality disorder (B-MCT) was found to significantly reduce borderline symptoms in 74 inpatients over a six-month period compared to a control group receiving progressive muscle relaxation.

While B-MCT showed effectiveness in reducing borderline symptoms, progressive muscle relaxation was more effective in alleviating depressive symptoms at long-term follow-up, suggesting that different interventions may target different aspects of mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of metacognitive training for patients with borderline personality disorder: Preliminary results. Schilling, L., Moritz, S., Kriston, L., et al.[2019]

Individuals with borderline personality disorder (BPD) and mixed anxiety/depressive disorders (MAD) use cognitive reappraisal strategies less effectively than healthy controls, despite using a similar number of tactics.

During cognitive reappraisal tasks, individuals with BPD and MAD expressed fewer words and reported lower effectiveness in reducing negative emotions compared to healthy individuals, indicating challenges in emotional regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Reappraisal of Negative Emotional Images in Borderline Personality Disorder: Content Analysis, Perceived Effectiveness, and Diagnostic Specificity. Daros, AR., Rodrigo, AH., Norouzian, N., et al.[2021]

Metacognitive interpersonal therapy (MIT) significantly improved emotional dysregulation in patients with borderline personality disorder (BPD), showing a very large effect size (Cohen's d = 0.84) compared to structured clinical management (SCM) which had a large effect size (d = 0.76).

Both MIT and SCM were effective in reducing BPD symptoms and improving emotional regulation, but MIT had a greater impact on metacognitive functions and impulsivity, while SCM led to a larger decrease in overall BPD symptomatology. Additionally, both therapies modulated amygdala activation, indicating a neurobiological mechanism at play.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive interpersonal therapy in borderline personality disorder: Clinical and neuroimaging outcomes from the CLIMAMITHE study-A randomized clinical trial. Rossi, R., Corbo, D., Magni, LR., et al.[2023]

Metacognitive training for borderline patients (B-MCT) was well-accepted and feasible, showing significantly better subjective outcomes compared to an active control group, including improvements in symptomatology and cognitive abilities among 48 inpatients with borderline personality disorder.

Participants reported higher enjoyment and likelihood of recommending B-MCT, indicating its potential as a beneficial add-on intervention, although further research with larger samples is necessary to fully understand its impact on mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Results on Acceptance, Feasibility, and Subjective Efficacy of the Add-On Group Intervention Metacognitive Training for Borderline Patients. Schilling, L., Moritz, S., Köther, U., et al.[2020]

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