Mindfulness and brain feedback for treating depression in teens
Targeting Adolescent Depression Symptoms Using Network-based Real-time fMRI Neurofeedback and Mindfulness Meditation (NIMH); Mindfulness-Based Real-Time fMRI Neurofeedback for Depression (IRB)
This study is testing a new way to help teens with depression by using mindfulness and brain feedback to see if it can reduce negative thinking and improve their mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05617495 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of a mindfulness-based real-time fMRI neurofeedback intervention aimed at improving clinical outcomes for adolescents suffering from major depressive disorder (MDD). The study focuses on rumination, a key factor in depression, by targeting the neural mechanisms associated with it. Participants will engage in mindfulness practices while receiving neurofeedback to help alter brain activity linked to ruminative thinking. The goal is to enhance treatment efficacy for adolescents who struggle with traditional therapies.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-18 who meet the diagnostic criteria for major depressive disorder and are fluent in English.
Not a fit: Patients with a history of primary psychotic disorders, severe substance use, or other specified mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel and effective treatment option for adolescents with depression, particularly those who do not respond to standard therapies.
How similar studies have performed: While mindfulness has shown promise in mental health treatment, this specific approach combining mindfulness with fMRI neurofeedback is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 13-18 years-old * Written informed assent/consent and parental/guardian permission for 13-17 year-olds or informed consent for 18 year-olds * Tanner puberty stage ≥3 * Meets current diagnostic criteria for MDD * English fluency Exclusion Criteria: * Lifetime history of primary psychotic disorders, bipolar disorder, oppositional defiant disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disorders * Substance use disorder, moderate or severe in past 6 months * Active suicidal ideation with a specific plan * History of seizure disorder * Medical or neurological illness (e.g., severe head injury) * MRI contraindications * Current psychotropic medication use other than antidepressant medication * Intelligence quotient (IQ) \<80.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Northeastern University — Boston, Massachusetts, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Randy P Auerbach, PhD
- Email: rpa2009@cumc.columbia.edu
- Phone: 646-774-5745
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.