Using mindfulness-based neurofeedback to enhance psychotherapy for adults with borderline personality disorder
Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)
This study is testing if using mindfulness-based brain training can help adults with borderline personality disorder feel better during their therapy sessions.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06446765 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of mindfulness-based real-time functional magnetic resonance imaging (fMRI) neurofeedback in enhancing the outcomes of evidence-based psychotherapy for adults diagnosed with Borderline Personality Disorder (BPD). Participants will receive either mindfulness-based neurofeedback or control neurofeedback while undergoing psychotherapy. The study will assess the impact of this intervention on the symptoms of BPD and overall mental health. The research will involve adults aged 18-60 who meet specific inclusion criteria and will be conducted at the Connecticut Mental Health Center.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 who have been diagnosed with borderline personality disorder and can maintain their current treatment regimen.
Not a fit: Patients currently undergoing dialectical behavior therapy or those with severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve therapeutic outcomes for patients with borderline personality disorder.
How similar studies have performed: While mindfulness-based interventions have shown promise in mental health treatment, the specific combination of fMRI neurofeedback and psychotherapy for BPD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut
- Connecticut Mental Health Center — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Sarah K Fineberg, MD PhD — Yale University
- Study coordinator: Sarah K Fineberg, MD PhD
- Email: sarah.fineberg@yale.edu
- Phone: 203-974-7265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.