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NCT06446765 | NOT YET RECRUITING | Borderline Personality Disorder

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

Condition or disease

Borderline Personality Disorder

Intervention/treatment

mindfulness-based Neurofeedback

control Neurofeedback

Phase

PHASE2

Detailed Description:

The focus of this study is Aim 1.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)
Actual Study Start Date : 2025-02
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 the study PI
    • Eligibility will be determined by study personnel.
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder

Location Details

NCT06446765

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How to Participate

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Locations

Not yet recruiting

United States, Connecticut

Connecticut Mental Health Center

New Haven, Connecticut, United States, 06519