Back to resultsMeasuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
real time fMRI neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
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
Sites / Locations
- Connecticut Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Neurofeedback in conjunction with Dialectical Behavior Therapy
Dialectical Behavior Therapy (treatment as usual)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
Full Information
NCT ID
NCT04306341
First Posted
March 10, 2020
Last Updated
May 19, 2023
Sponsor
Yale University
Collaborators
AE Foundation, Central Institute of Mental Health, Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT04306341
Brief Title
Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
Official Title
Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
AE Foundation, Central Institute of Mental Health, Mannheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Neurofeedback in conjunction with Dialectical Behavior Therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Dialectical Behavior Therapy (treatment as usual)
Intervention Type
Behavioral
Intervention Name(s)
real time fMRI neurofeedback
Intervention Description
Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.
Primary Outcome Measure Information:
Title
Change in Affective Lability
Description
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.
Time Frame
Baseline compared to the week after intervention
Secondary Outcome Measure Information:
Title
Change in Mean Negative Affect
Description
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.
Time Frame
Baseline compared to the week after intervention
Title
Change in Borderline Personality Disorder Symptoms
Description
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.
Time Frame
Baseline compared to the week after intervention
Title
Change in Amygdala Regulation
Description
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
Time Frame
Baseline compared to the week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah K Fineberg, MD PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Hampson, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
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