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Neurofeedback for Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amygdala Neurofeedback
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring fMRI neurofeedback, amygdala

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • right-handed adults (ages 18 - 55) with a primary diagnosis of Borderline Personality Disorder according to diagnostic criteria in the Structured Interview for DSM Personality Disorders
  • must be able to give written informed consent prior to participation
  • unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
  • English speaking

Exclusion Criteria:

  • have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
  • Current moderate or severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild alcohol or substance use would also interfere with the effects of the intervention.
  • have a history of traumatic brain injury
  • are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
  • are currently pregnant or breast feeding
  • are unable to complete questionnaires written in English
  • current (within 3 weeks of testing) use of any antipsychotics, benzodiazepines, beta-blockers, or other medications (except SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population
  • have a DSM-5 diagnosis of psychotic or organic mental disorder
  • have any eye problems or difficulties in corrected vision.
  • Serious suidicial ideation

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amygdala Neurofeedback

Arm Description

Participants will undergo real-time fMRI neurofeedback training to increase their amygdala response while recalling positive autobiographical memories. 2 sessions will occur within a one week period.

Outcomes

Primary Outcome Measures

Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks
Assessment of severity of borderline symptoms. This scale contains 24 items rated on a four-point scale (0=false to 3=very true). Scores range from 0-72, and are converted to T scores, with higher scores indicating more borderline symptoms. Scores below 59 indicate healthy, scores at or above 70T indicate the respondent is likely to have borderline personality disorder.

Secondary Outcome Measures

Change from Baseline in Beck Depression Inventory at 12 weeks
Assessment of severity of depressive symptoms. This is a 21 item self-report scale with items rated from 0-3 and scores ranging from 0 to 63 with higher scores indicating worse depression. A score less than 13 is considered to be in the healthy range, scores 14-19 indicate mild depression, scores 20-28 indicate moderate depression, scores 29-63 indicate severe depression.

Full Information

First Posted
May 25, 2022
Last Updated
August 2, 2023
Sponsor
University of Pittsburgh
Collaborators
AE Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05398627
Brief Title
Neurofeedback for Borderline Personality Disorder
Official Title
Amygdala rtfMRI Neurofeedback for Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
AE Foundation

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
The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as an intervention for borderline personality disorder.
Detailed Description
We will assess the treatment effects of real-time fMRI neurofeedback in adults with borderline personality disorder. This is an experimental longitudinal design where participants will be followed every two weeks after receiving 2 sessions of neurofeedback from the amygdala . Procedures involve a battery of self-report measures, fMRI and psychophysiological indices (heart rate, respiration).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
fMRI neurofeedback, amygdala

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amygdala Neurofeedback
Arm Type
Experimental
Arm Description
Participants will undergo real-time fMRI neurofeedback training to increase their amygdala response while recalling positive autobiographical memories. 2 sessions will occur within a one week period.
Intervention Type
Behavioral
Intervention Name(s)
Amygdala Neurofeedback
Intervention Description
real-time feedback on the hemodynamic response of the amygdala during positive autobiographical memory recall
Primary Outcome Measure Information:
Title
Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks
Description
Assessment of severity of borderline symptoms. This scale contains 24 items rated on a four-point scale (0=false to 3=very true). Scores range from 0-72, and are converted to T scores, with higher scores indicating more borderline symptoms. Scores below 59 indicate healthy, scores at or above 70T indicate the respondent is likely to have borderline personality disorder.
Time Frame
Baseline vs 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Beck Depression Inventory at 12 weeks
Description
Assessment of severity of depressive symptoms. This is a 21 item self-report scale with items rated from 0-3 and scores ranging from 0 to 63 with higher scores indicating worse depression. A score less than 13 is considered to be in the healthy range, scores 14-19 indicate mild depression, scores 20-28 indicate moderate depression, scores 29-63 indicate severe depression.
Time Frame
Baseline vs 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: right-handed adults (ages 18 - 55) with a primary diagnosis of Borderline Personality Disorder according to diagnostic criteria in the Structured Interview for DSM Personality Disorders must be able to give written informed consent prior to participation unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable) English speaking Exclusion Criteria: have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder Current moderate or severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild alcohol or substance use would also interfere with the effects of the intervention. have a history of traumatic brain injury are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body) are currently pregnant or breast feeding are unable to complete questionnaires written in English current (within 3 weeks of testing) use of any antipsychotics, benzodiazepines, beta-blockers, or other medications (except SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population have a DSM-5 diagnosis of psychotic or organic mental disorder have any eye problems or difficulties in corrected vision. Serious suidicial ideation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kymberly Young, PhD
Phone
412-648-6179
Email
youngk@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Barb, MSW
Phone
412-864-3514
Email
barbsm3@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kymberl Young, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kymberly Young
Phone
412-648-6179
Email
youngk@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be made available to researchers who sign a data sharing agreement with the PI

Learn more about this trial

Neurofeedback for Borderline Personality Disorder

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