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Recruiting Phase 2 NCT06446765

NCT06446765 Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder

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Clinical Trial Summary
NCT ID NCT06446765
Status Recruiting
Phase Phase 2
Sponsor Yale University
Condition Borderline Personality Disorder
Study Type INTERVENTIONAL
Enrollment 150 participants
Start Date 2025-03-13
Primary Completion 2026-05-30

Trial Parameters

Condition Borderline Personality Disorder
Sponsor Yale University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2025-03-13
Completion 2026-05-30
Interventions
mindfulness-based Neurofeedbackcontrol Neurofeedback

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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).

Eligibility Criteria

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

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