Clinical trial NCT06446765: Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Official title: Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Borderline Personality Disorder
Keywords: fMRI neurofeedback
mindfulness
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Connecticut Mental Health Center
name: National Institute of Mental Health (NIMH)
First posted: 2024-06-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 the study PI

Eligibility will be determined by study personnel.

Primary outcomes:
measure: Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)
timeFrame: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
measure: Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback
timeFrame: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Secondary outcomes:
measure: Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback.
timeFrame: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Sarah K Fineberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: