Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: real time fMRI neurofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: enrolled in YNHH DBT-IOP must meet specific clinical criteria Inclusion in Experimental group requires participants meet standard safety and quality control requirements for MR scanning For female participants, not pregnant and willing to use a reliable method of contraception during the study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Neurofeedback in conjunction with Dialectical Behavior Therapy | Behavioral: real time fMRI neurofeedback<br>* Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.<br>|
| No Intervention: Control<br>Dialectical Behavior Therapy (treatment as usual) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Negative Affect | This outcome will be measured by change in mean negative emotion score measured using ecologic momentary assessment (EMA: surveys sent to participants by smartphone app) repeatedly over a four-day period at each timepoint. The mean score 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 | 
| Change in Borderline Personality Disorder Symptoms | This outcome will be measured by change in Borderline Symptom List (BSL-23) score after neurofeedback. This scale has 23 items, each scored 0-4, and total score is mean item endorsement (sum of all items divided by 23). Higher scores indicate more symptom endorsement. | Baseline compared to the week after intervention | 
| Change in Amygdala Regulation | Change in ability to regulate amygdala activity when exposed to provocative images. Amygdala activity is measured as functional magnetic resonance imaging (fMRI) blood oxygen dependant (BOLD) signal | Baseline compared to the week after intervention |