Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

— MIND-BPD  

Official title:

Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446765
• Other study ID #: 2000037582
• Secondary ID: 1R61MH135009-01A
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2025
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: Sarah K Fineberg, MD PhD
• Phone: 203-974-7265
• Email: sarah.fineberg[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase the benefits of evidence-based psychotherapy for adults with Borderline Personality Disorder (BPD).

Description:

The focus of this study is Aim 1.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• age 18-60,
• be able to provide written informed consent,
• meet criteria for BPD on semi-structured clinical interview,
• able to plan to keep any prescribed medications and psychotherapy constant during the study
• fluent in English.

Exclusion criteria:

• current DBT psychotherapy outside the study
• lifetime primary psychotic disorder or Bipolar I disorder
• developmental disorder (e.g. autism)
• history of learning disorder
• moderate or severe substance use disorder in the last 6 months
• active suicidal ideation with intent or plan in the past 3 months
• history of major medical or neurologic disorder
• MRI contraindications, including pregnancy
• poor performance on reading task (WRAT > 11 errors)
• newly prescribed medications in the past 8 weeks
• daytime sedating medications (e.g. benzodiazepines, opiates, sedating neuroleptics)
• any scheduled daily benzodiazepines
• change in psychotherapy type or frequency in the past 12 weeks.
• At the discretion of the study PI Eligibility will be determined by study personnel.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• mindfulness-based Neurofeedback
Participants will complete one session of mindfulness-based fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.

Other:
• control Neurofeedback
Participants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Connecticut Mental Health Center, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)	Defined as within-DMN connectivity as the resting state seed-based connectivity between core nodes of medial prefrontal cortex (mPFC) and posterior cingulate cortex (PCC). Change = post-NF within-DMN connectivity - pre-NF within-DMN connectivity.	From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Primary	Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback	Defined as DMN-FPCN anticorrelation as the fMRI seed-based connectivity from mPFC to dorsolateral prefrontal cortex (dlPFC)). Change = post-NF mPFC-dlPFC anticorrelation - pre-NF mPFC-dlPFC anticorrelation	From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Secondary	Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback.	The State Mindfulness Scale (SMS) is a validated self-reported 21 item instrument assessing state mindfulness over the past 15 minutes. Possible scores range from 21 (not mindful) to 105 (very mindful).	From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day