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Cognitive Reappraisal Training for Borderline Personality Disorder (BPD Trial)

N/A
Recruiting
Led By Harold Koenigsberg, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights

BPD Trial Summary

This trial will test a new clinical intervention for patients with Borderline Personality Disorder. The intervention is training in reappraisal-by-distancing, which is hypothesized to improve neural and behavioral targets. If successful, this intervention has the potential to improve clinical outcomes for patients with BPD.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is a psychological training intervention rather than a drug, traditional physical side effects are not expected. However, participants may experience emotional discomfort when engaging in the exercises.

BPD Trial Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in PINES Network activity
Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)
Secondary outcome measures
Change in Affective Lability Scale total (ALS)
Change in Beck Depression Scale score (BDI)
Change in Difficulty in Emotion Regulation Scale Scores (DERS)
+3 more

BPD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Reappraisal-by-Distancing (CRD)Experimental Treatment1 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 Control1 Intervention
Subjects will be coached to practice their customary emotion regulatory techniques in a treatment occurring twice a week for 6 weeks.

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Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,199 Total Patients Enrolled
11 Trials studying Borderline Personality Disorder
1,823 Patients Enrolled for Borderline Personality Disorder
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,398 Total Patients Enrolled
3 Trials studying Borderline Personality Disorder
209 Patients Enrolled for Borderline Personality Disorder
William Marsh Rice UniversityOTHER
45 Previous Clinical Trials
27,775 Total Patients Enrolled

Media Library

Cognitive Reappraisal by Distancing Clinical Trial Eligibility Overview. Trial Name: NCT04967222 — N/A
Borderline Personality Disorder Research Study Groups: Cognitive Reappraisal-by-Distancing (CRD), Control Downregulate Condition (CD)
Borderline Personality Disorder Clinical Trial 2023: Cognitive Reappraisal by Distancing Highlights & Side Effects. Trial Name: NCT04967222 — N/A
Cognitive Reappraisal by Distancing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04967222 — N/A
Borderline Personality Disorder Patient Testimony for trial: Trial Name: NCT04967222 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research project currently seeking participants?

"Indeed, the information accessible on clinicaltrials.gov claims that this medical trial is presently recruiting volunteers. The study was initially posted on November 30th 2021 and has been recently amended as of July 7th 2022. A total of 228 individuals are required at a single clinical centre for enrollment in the trial to be completed."

Answered by AI

Is participation in this trial limited to individuals of a certain age bracket?

"The investigators for this trial have specified that only those aged 18 to 55 can be enrolled. For younger and elderly participants, there are 6 separate studies available for their consideration."

Answered by AI

Who is the optimal participant for this clinical research?

"This trial is enrolling 228 suitable participants aged 18 - 55 diagnosed with Borderline personality disorder. To qualify, applicants must be medically sound and mentally capable of giving informed consent in written form."

Answered by AI

What are the primary goals that this trial is aiming to accomplish?

"This medical trial's primary outcome is the Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD). Secondary outcomes are the Difficulty in Emotion Regulation Scale Scores (DERS) from 6 to 216, Beck Depression Inventory Score 0-63, and State-Trait Anxiety Inventory score 20 - 80. All of these metrics will be assessed at Baseline and up to 6 weeks into treatment."

Answered by AI

To what extent is the public participating in this experiment?

"Correct. Documentation on clinicaltrials.gov attests to this experiment being currently open for recruitment, with the initial posting date of November 30th 2021 and last update dated July 7th 2022. The study is aiming to enroll 228 participants from a single location."

Answered by AI

Who else is applying?

What state do they live in?
Florida
New Jersey
Other
New York
How old are they?
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
3+

Why did patients apply to this trial?

Looking for answers. I want compensation. I'm sick of meds stopping. Please help me with my BDP I don’t know how to deal with it and it interferes in my life everyday.
PatientReceived no prior treatments
I’ve tried everything available according to over 12 mental health professionals but NOTHING HAS WORKED.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Can a Swedish patient be accepted into the trial? Will I get transportation? Financial compensation?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
  1. Icahn School of Medicine at Mount Sinai: < 48 hours
~5 spots leftby Jul 2024