Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder (MIND-BPD)

Yale University

Status and phase: Enrolling; Phase 2

Conditions: Borderline Personality Disorder

Treatments: Behavioral: mindfulness-based Neurofeedback; Other: control Neurofeedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06446765

1R61MH135009-01A1 (Other Grant/Funding Number)

2000037582

Details and patient eligibility

About

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).

Full description

The focus of this study is Aim 1.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

mindfulness-based Neurofeedback

Experimental group

Description:

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

Treatment:

Behavioral: mindfulness-based Neurofeedback

control Neurofeedback

Other group

Description:

Participants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.

Treatment:

Other: control Neurofeedback