Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
1 other identifier
interventional
3
1 country
1
Brief Summary
This study will test the impacts of real time fMRI neurofeedback in patients with Borderline Personality Disorder. This is a pilot study in a small number of people enrolled in clinical programs at Yale New Haven Hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 12, 2020
CompletedStudy Start
First participant enrolled
November 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2022
CompletedMay 22, 2023
May 1, 2023
1.9 years
March 10, 2020
May 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Affective Lability
This outcome will be measured by the change in variance of negative emotions measured using ecologic momentary assessment (EMA: surveys sent to participants by smartphone app) repeatedly over a four-day period at each timepoint. The variance between measurements at each timepoint will be calculated, and compared to the other timepoints. There will be 5 negative emotion items at each timepoint, and a higher score indicates more negative emotion.
Baseline compared to the week after intervention
Secondary Outcomes (3)
Change in Mean Negative Affect
Baseline compared to the week after intervention
Change in Borderline Personality Disorder Symptoms
Baseline compared to the week after intervention
Change in Amygdala Regulation
Baseline compared to the week after intervention
Study Arms (2)
Experimental
EXPERIMENTALNeurofeedback in conjunction with Dialectical Behavior Therapy
Control
NO INTERVENTIONDialectical Behavior Therapy (treatment as usual)
Interventions
Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.
Eligibility Criteria
You may qualify if:
- enrolled in YNHH DBT-IOP
- must meet specific clinical criteria
- For female participants, not pregnant and willing to use a reliable method of contraception during the study
You may not qualify if:
- IQ\<70
- vision problem not able to be corrected to normal range
- medication changes w/in one month
- Lifetime hx of schizophrenia, schizoaffective d/o, bipolar I disorder.
- illicit substance use within 7 days of MRI scans
- taking scheduled opiates
- taking scheduled benzodiazepines
- taking scheduled anti-histamines
- history of seizures
- significant current or past neurologic illness
- BMI \< 16.5
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- AE Foundationcollaborator
- Central Institute of Mental Health, Mannheimcollaborator
Study Sites (1)
Connecticut Mental Health Center
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah K Fineberg, MD PhD
Yale University
- PRINCIPAL INVESTIGATOR
Michelle Hampson, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2020
First Posted
March 12, 2020
Study Start
November 15, 2020
Primary Completion
October 7, 2022
Study Completion
October 7, 2022
Last Updated
May 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share