Neurofeedback for Borderline Personality Disorder

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05398627
• Collaborator: AE Foundation (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder	Behavioral: Amygdala Neurofeedback	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Amygdala rtfMRI Neurofeedback for Borderline Personality Disorder
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amygdala Neurofeedback 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.	Behavioral: Amygdala Neurofeedback; real-time feedback on the hemodynamic response of the amygdala during positive autobiographical memory recall

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks [Baseline vs 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

1. Change from Baseline in Beck Depression Inventory at 12 weeks [Baseline vs 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• AE Foundation

Investigators

• Principal Investigator: Kymberl Young, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kymberly Young, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT05398627
• Other Study ID Numbers: STUDY22040107
• First Posted: Jun 1, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kymberly Young, Associate Professor, University of Pittsburgh: fMRI neurofeedback; amygdala
• Additional relevant MeSH terms: Personality Disorders; Borderline Personality Disorder

Study Results

No Results Posted as of Aug 5, 2022