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

Phase 2

Recruiting

• Conditions: Borderline Personality Disorder
• Interventions: Behavioral: mindfulness-based Neurofeedback; Other: control Neurofeedback

• Registration Number: NCT06446765
• Lead Sponsor: Yale University

Brief 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).

Detailed Description

The focus of this study is Aim 1.

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-06
• Study Start: 2025-03-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mindfulness-based Neurofeedback	mindfulness-based Neurofeedback	Participants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
control Neurofeedback	control Neurofeedback	Participants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.

Primary Outcome Measures

Name	Time	Method
Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)	From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day	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.
Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback	From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback.	From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day	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).

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States